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Adaptive Nutrition and Exercise Weight Loss (A-NEW) Study (A-NEW)

Primary Purpose

Breast Cancer, Overweight or Obesity

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Contrave

Behavioral Weight Loss

About this trial

This is an interventional other trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Female, at least 3 months after completion of local therapy (e.g. surgery, radiation), and if applicable, adjuvant chemotherapy
Diagnosed within 10 years with histologically-confirmed ductal carcinoma in situ (DCIS) or stage I-III invasive carcinoma of the breast
Up to date with recommended screening mammography within one year
Current BMI ≥ 30 kg/m2 or BMI 27.0-29.9 kg/m2 with hypertension, non-insulin dependent diabetes or hyperlipidemia; and weight ≤ 400 lbs
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Willingness to change diet, physical activity, track behaviors, engage in weekly and monthly contacts and visit, and take chronic weight loss medication
Able to read and write the English language without assistance and daily access to the e-mail and/or smartphone
Patient is aware of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.

Exclusion Criteria:

Serious/uncontrolled medical condition at the discretion of the Protocol Chair/designee likely to hinder accurate measurement of weight or any condition for which weight loss is contraindicated or would affect adipokine and inflammatory markers (e.g. active malignancy, end stage renal disease on dialysis, cirrhosis, autoimmune disease, adrenal disease, uncontrolled hypertension, seizure disorder, and history of bariatric surgery)
Pregnant or nursing within past 6 months, or plans to become pregnant in the next year
Currently enrolled or planning to enroll in a weight loss program (e.g. Weight Watchers, Jenny Craig, Nutrisystem and Medifast) or to take a chronic weight loss medication.
Diabetes on insulin or sulfonylureas within the past 3 months
Unstable psychiatric disorder or bulimia/anorexia nervosa
Alcohol, nicotine or substance abuse; or undergoing abrupt discontinuation of alcohol, benzodiazepine, barbiturate or anti-epileptic drug
Use of the following medications are excluded:
- Monoamine oxidase (MAO) inhibitors (must be >14 days from discontinuation)
- Thyroid medication use unless on stable doses for at least the past 3 months
- Buproprion containing products or opiate agonists (must be >14 days from discontinuation)
- Medications that cause weight loss (e.g., lorcaserin, phentermine, orlistat, Qsymia, Contrave) within the past 3 months
- Medications that are likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine, oral contraceptive pills, hormone replacement therapy) within the past 3 months. NOTE: An exception to this is that SSRI's and SNRI's are allowed if participant has been on stable doses for at least 3 months (if discontinued, a washout of 2 weeks from prior selective serotonin reuptake inhibitor (SSRI)/Serotonin-norepinephrine reuptake inhibitor (SNRI) use is required).
- Medications that may affect adipokine or inflammatory markers (e.g., metformin, glitazones, steroids, angiotensin converting enzyme (ACE) inhibitors, beta blockers and statins) unless on stable doses ≥3 months prior to registration (if discontinued, a washout of 2 weeks from prior use is required). Concurrent NSAIDs are allowed if use is limited to <3 times per week; chronic NSAIDs are permitted on study only if use has been ≥3 times per week for at least 3 months prior to registration and is expected to continue.

Sites / Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SLOW-BWL

FAST-BWL

Arm Description

All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose <5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave [as per the Food and Drug Administration (FDA) recommended administration] starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6.

Outcomes

Primary Outcome Measures

Number of patients with 5 percent weight loss (in SLOW-BWL)

To assess the rate of SLOW-BWL patients attaining at least 5% weight loss of their baseline body weight at 6 months with the addition of Contrave to BWL at week 9.

Secondary Outcome Measures

Change in HbA1c levels among SLOW-BWL participants who achieve ≥5% weight loss

To compare HbA1c (%) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Change in HbA1c levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

To compare HbA1c (%) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Change in HbA1c levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

To compare HbA1c (%) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Change in IGF1 levels among SLOW-BWL participants who achieve ≥5% weight loss

To compare Insulin-like growth factor 1 (IGF1) (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Change in IGF1 levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

To compare IGF1 (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Change in IGF1 levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

To compare IGF1 (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Change in Fasting glucose levels among SLOW-BWL participants who achieve ≥5% weight loss

To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Change in Fasting glucose levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Change in Fasting glucose levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Change in Fasting lipids levels among SLOW-BWL participants who achieve ≥5% weight loss

To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Change in Fasting lipids levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Change in Fasting lipids levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Change in Fasting insulin levels among SLOW-BWL participants who achieve ≥5% weight loss

To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Change in Fasting insulin levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Change in Fasting insulin levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Change in Adiponectin levels among SLOW-BWL women who achieve ≥5% weight loss

To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Change in Adiponectin levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Change in Adiponectin levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Change in Leptin levels among SLOW-BWL participants who achieve ≥5% weight loss

To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Change in Leptin levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Change in Leptin levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

Change in Microbiome composition among SLOW-BWL participants who achieve ≥5% weight loss

To compare microbiome composition (ratio of bacteroides and firmacutes) at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Change in Microbiome composition among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

To compare microbiome composition (ratio of bacteroides and firmacutes) at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Change in Microbiome composition among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

To compare microbiome composition (ratio of bacteroides and firmacutes) at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Change in Scores on Godin Leisure-Time Exercise questionnaire among SLOW-BWL participants who achieve ≥5% weight loss

To compare Godin (score range start from 0 with no upper limit but higher scores indicate more exercise) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Change in Scores on Godin Leisure-Time Exercise questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

To compare Godin (score range start from 0 with no upper limit but higher scores indicate more exercise) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Change in Scores on Godin Leisure-Time Exercise questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

To compare Godin (score range start from 0 with no upper limit but higher scores indicate more exercise) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Change in Scores on Pittsburgh Sleep Quality Index (PSQI) questionnaire among SLOW-BWL participants who achieve ≥5% weight loss

To compare PSQI (scores range 0-21 with higher scores indicating poorer sleep) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Change in Scores on Pittsburgh Sleep Quality Index (PSQI) questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

To compare PSQI (scores range 0-21 with higher scores indicating poorer sleep) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Change in Scores on Pittsburgh Sleep Quality Index (PSQI) questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

To compare PSQI (scores range 0-21 with higher scores indicating poorer sleep) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss

To compare Physical Function - Short Form (scores range 10-50 with higher scores indicating better physical functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Change in Scores on PROMIS Physical Function - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Change in Scores on PROMIS Physical Function - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

To compare Physical Function - Short Form (scores range 10-50 with higher scores indicating better physical functioning) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Change in Scores on PROMIS Pain Interference - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss

To compare Pain Interference - Short Form (scores range 6-30 with lower scores indicating less pain interference) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Change in Scores on PROMIS Pain Interference - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

To compare Pain Interference - Short Form (scores range 6-30 with lower scores indicating less pain interference) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Change in Scores on PROMIS Pain Interference - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

To compare Pain Interference - Short Form (scores range 6-30 with lower scores indicating less pain interference) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Change in Scores on PROMIS Fatigue - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss

To compare Fatigue - Short Form (scores range 7-35 with higher scores indicating more fatigue) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Change in Scores on PROMIS Fatigue - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

To compare Fatigue - Short Form (scores range 7-35 with higher scores indicating more fatigue) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Change in Scores on PROMIS Fatigue - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

To compare Fatigue - Short Form (scores range 7-35 with higher scores indicating more fatigue) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Change in Scores on PROMIS Emotional Distress - Depression - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss

To compare Depression - Short Form (scores range 8-40 with lower scores indicating lower levels of depression) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Change in Scores on PROMIS Emotional Distress - Depression - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

To compare Depression - Short Form (scores range 8-40 with lower scores indicating lower levels of depression) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Change in Scores on PROMIS Emotional Distress - Depression - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

To compare Depression - Short Form (scores range 8-40 with lower scores indicating lower levels of depression) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Change in Scores on PROMIS Emotional Distress - Anxiety - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss

To compare Anxiety - Short Form (scores range 7-35 with lower scores indicating lower levels of anxiety) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Change in Scores on PROMIS Emotional Distress - Anxiety - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

To compare Anxiety - Short Form (scores range 7-35 with lower scores indicating lower levels of anxiety) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Change in Scores on PROMIS Emotional Distress - Anxiety - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

To compare Anxiety - Short Form (scores range 7-35 with lower scores indicating lower levels of anxiety) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Change in Scores on Sexual Function questionnaire among SLOW-BWL participants who achieve ≥5% weight loss

To compare Sexual Function (scores range 4-20 with lower scores indicating better sexual functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Change in Scores on Sexual Function questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

To compare Sexual Function (scores range 4-20 with lower scores indicating better sexual functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Change in Scores on Sexual Function questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

To compare Sexual Function (scores range 4-20 with lower scores indicating better sexual functioning) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Change in NCI quick food scan comparison among SLOW-BWL participants who achieve ≥5% weight loss

To compare NCI quick food scan scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Change in NCI quick food scan comparison among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

To compare NCI quick food scan scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Change in NCI quick food scan comparison among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

To compare NCI quick food scan scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) among SLOW-BWL participants who achieve ≥5% weight loss

To compare FACT-ES (scores range 0-76 with higher scores indicating poorer functional assessment) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

To compare FACT-ES (scores range 0-76 with higher scores indicating poorer functional assessment) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

To compare FACT-ES (scores range 0-76 with higher scores indicating poorer functional assessment) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Change in Minutes of Moderate to Vigorous Physical Activity (MVPA)

To compare minutes of MVPA reported in Fitbit at 2 and 6 months to baseline levels among SLOW-BWL who achieved ≥5% weight loss vs the SLOW-BWL who did not achieve 5% weight loss.

Change in Number of daily steps

To compare the number of daily steps reported in Fitbit at 2 and 6 months to baseline levels among SLOW-BWL who achieved ≥5% weight loss vs the SLOW-BWL who did not achieve 5% weight loss.

Full Information

NCT ID

NCT04499950

First Posted

July 31, 2020

Last Updated

July 7, 2023

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

American Institute for Cancer Research, Breast Cancer Research Foundation, Hopkins-WellSpan Cancer Research Fund

1. Study Identification

Unique Protocol Identification Number

NCT04499950

Brief Title

Adaptive Nutrition and Exercise Weight Loss (A-NEW) Study

Acronym

A-NEW

Official Title

A Phase II Single Arm Adaptive Weight Loss Study in Women With Early Stage Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 8, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

American Institute for Cancer Research, Breast Cancer Research Foundation, Hopkins-WellSpan Cancer Research Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

This is a single arm phase II study designed to determine the effects of pharmacotherapy and a remote behavioral weight loss intervention on weight loss in breast cancer survivors who are overweight or obese, and the impact of successful weight loss on serum biomarkers and gut microbiome.

Detailed Description

The investigators will evaluate the extent to which implementation of a chronic weight loss medication, Contrave® (Naltrexone/Bupropion), is associated with achieving ≥5% weight loss. All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL) while those who lose <5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave (as per Federal Drug Administration [FDA] recommended administration) starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6. During month 3, all participants continue to have weekly calls with the behavioral coach and will be asked about symptoms, which may be related to initiation of pharmacotherapy; any symptoms are reported to the PI for further evaluation. In addition to total weight loss, the investigators will evaluate biomarkers associated with obesity, microbiome and cardiometabolic factors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Overweight or Obesity

7. Study Design

Primary Purpose

Other

Study Phase

Phase 2

Interventional Study Model

Sequential Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SLOW-BWL

Arm Type

Experimental

Arm Description

Arm Title

FAST-BWL

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Contrave

Other Intervention Name(s)

Naltrexone/Bupropion

Intervention Description

Initiate Contrave at 1 tab in morning (AM) for Week 9; then 1 tab in AM and 1 tab in evening (PM) for Week 10; then 2 tab in AM and 1 tab in PM for Week 11; then 2 tab in AM and 2 tab in PM for week 12; then constant dose for months 4-6.

Intervention Type

Behavioral

Intervention Name(s)

Behavioral Weight Loss

Intervention Description

6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6.

Primary Outcome Measure Information:

Title

Number of patients with 5 percent weight loss (in SLOW-BWL)

Description

To assess the rate of SLOW-BWL patients attaining at least 5% weight loss of their baseline body weight at 6 months with the addition of Contrave to BWL at week 9.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Change in HbA1c levels among SLOW-BWL participants who achieve ≥5% weight loss

Description

To compare HbA1c (%) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in HbA1c levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Description

To compare HbA1c (%) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in HbA1c levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

Description

To compare HbA1c (%) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in IGF1 levels among SLOW-BWL participants who achieve ≥5% weight loss

Description

To compare Insulin-like growth factor 1 (IGF1) (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in IGF1 levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Description

To compare IGF1 (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Time Frame

Baseline, 2 months and 6 Months

Title

Change in IGF1 levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

Description

To compare IGF1 (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Fasting glucose levels among SLOW-BWL participants who achieve ≥5% weight loss

Description

To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Fasting glucose levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Description

To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Fasting glucose levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Fasting lipids levels among SLOW-BWL participants who achieve ≥5% weight loss

Description

To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Fasting lipids levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Description

To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Fasting lipids levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

Description

To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Time Frame

6 Months

Title

Change in Fasting insulin levels among SLOW-BWL participants who achieve ≥5% weight loss

Description

To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Fasting insulin levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Description

To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Fasting insulin levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Adiponectin levels among SLOW-BWL women who achieve ≥5% weight loss

Description

To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Adiponectin levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Description

To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Adiponectin levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

Description

To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Leptin levels among SLOW-BWL participants who achieve ≥5% weight loss

Description

To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Leptin levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Description

To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Leptin levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

Description

To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Microbiome composition among SLOW-BWL participants who achieve ≥5% weight loss

Description

To compare microbiome composition (ratio of bacteroides and firmacutes) at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Microbiome composition among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Microbiome composition among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on Godin Leisure-Time Exercise questionnaire among SLOW-BWL participants who achieve ≥5% weight loss

Description

To compare Godin (score range start from 0 with no upper limit but higher scores indicate more exercise) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on Godin Leisure-Time Exercise questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on Godin Leisure-Time Exercise questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on Pittsburgh Sleep Quality Index (PSQI) questionnaire among SLOW-BWL participants who achieve ≥5% weight loss

Description

To compare PSQI (scores range 0-21 with higher scores indicating poorer sleep) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on Pittsburgh Sleep Quality Index (PSQI) questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on Pittsburgh Sleep Quality Index (PSQI) questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on PROMIS Physical Function - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on PROMIS Physical Function - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on PROMIS Pain Interference - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on PROMIS Pain Interference - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on PROMIS Pain Interference - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on PROMIS Fatigue - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss

Description

To compare Fatigue - Short Form (scores range 7-35 with higher scores indicating more fatigue) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on PROMIS Fatigue - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on PROMIS Fatigue - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on PROMIS Emotional Distress - Depression - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on PROMIS Emotional Distress - Depression - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on PROMIS Emotional Distress - Anxiety - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss

Description

To compare Anxiety - Short Form (scores range 7-35 with lower scores indicating lower levels of anxiety) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on PROMIS Emotional Distress - Anxiety - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on Sexual Function questionnaire among SLOW-BWL participants who achieve ≥5% weight loss

Description

To compare Sexual Function (scores range 4-20 with lower scores indicating better sexual functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on Sexual Function questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on Sexual Function questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in NCI quick food scan comparison among SLOW-BWL participants who achieve ≥5% weight loss

Description

To compare NCI quick food scan scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in NCI quick food scan comparison among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Description

To compare NCI quick food scan scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in NCI quick food scan comparison among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

Description

To compare NCI quick food scan scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) among SLOW-BWL participants who achieve ≥5% weight loss

Description

To compare FACT-ES (scores range 0-76 with higher scores indicating poorer functional assessment) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Description

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Minutes of Moderate to Vigorous Physical Activity (MVPA)

Description

To compare minutes of MVPA reported in Fitbit at 2 and 6 months to baseline levels among SLOW-BWL who achieved ≥5% weight loss vs the SLOW-BWL who did not achieve 5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Title

Change in Number of daily steps

Description

To compare the number of daily steps reported in Fitbit at 2 and 6 months to baseline levels among SLOW-BWL who achieved ≥5% weight loss vs the SLOW-BWL who did not achieve 5% weight loss.

Time Frame

Baseline, 2 months and 6 Months

Other Pre-specified Outcome Measures:

Title

Number of patients with 5% weight loss (in FAST-BWL)

Description

To assess the proportion of women in the FAST-BWL arm who maintain ≥5% weight loss at 6 months.

Time Frame

6 months

Title

Number of participants with AA genotype and 5% weight loss

Description

To assess prevalence of AA genotype of MnSOD in breast cancer survivors with excess weight and if a greater proportion of women with the AA genotype achieve ≥5% weight loss and improvement in biomarkers at 6 months compared to the women who do not.

Time Frame

6 months

Title

Number of participants with AA genotype and Contrave

Description

To determine if women who display the AA genotype of MnSOD and undergo addition of Contrave to BWL have greater weight loss compared to women who do not receive Contrave.

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female, at least 3 months after completion of local therapy (e.g. surgery, radiation), and if applicable, adjuvant chemotherapy Diagnosed within 10 years with histologically-confirmed ductal carcinoma in situ (DCIS) or stage I-III invasive carcinoma of the breast Up to date with recommended screening mammography within one year Current BMI ≥ 30 kg/m2 or BMI 27.0-29.9 kg/m2 with hypertension, non-insulin dependent diabetes or hyperlipidemia; and weight ≤ 400 lbs Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Willingness to change diet, physical activity, track behaviors, engage in weekly and monthly contacts and visit, and take chronic weight loss medication Able to read and write the English language without assistance and daily access to the e-mail and/or smartphone Patient is aware of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form. Exclusion Criteria: Serious/uncontrolled medical condition at the discretion of the Protocol Chair/designee likely to hinder accurate measurement of weight or any condition for which weight loss is contraindicated or would affect adipokine and inflammatory markers (e.g. active malignancy, end stage renal disease on dialysis, cirrhosis, autoimmune disease, adrenal disease, uncontrolled hypertension, seizure disorder, and history of bariatric surgery) Pregnant or nursing within past 6 months, or plans to become pregnant in the next year Currently enrolled or planning to enroll in a weight loss program (e.g. Weight Watchers, Jenny Craig, Nutrisystem and Medifast) or to take a chronic weight loss medication. Diabetes on insulin or sulfonylureas within the past 3 months Unstable psychiatric disorder or bulimia/anorexia nervosa Alcohol, nicotine or substance abuse; or undergoing abrupt discontinuation of alcohol, benzodiazepine, barbiturate or anti-epileptic drug Use of the following medications are excluded: Monoamine oxidase (MAO) inhibitors (must be >14 days from discontinuation) Thyroid medication use unless on stable doses for at least the past 3 months Buproprion containing products or opiate agonists (must be >14 days from discontinuation) Medications that cause weight loss (e.g., lorcaserin, phentermine, orlistat, Qsymia, Contrave) within the past 3 months Medications that are likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine, oral contraceptive pills, hormone replacement therapy) within the past 3 months. NOTE: An exception to this is that SSRI's and SNRI's are allowed if participant has been on stable doses for at least 3 months (if discontinued, a washout of 2 weeks from prior selective serotonin reuptake inhibitor (SSRI)/Serotonin-norepinephrine reuptake inhibitor (SNRI) use is required). Medications that may affect adipokine or inflammatory markers (e.g., metformin, glitazones, steroids, angiotensin converting enzyme (ACE) inhibitors, beta blockers and statins) unless on stable doses ≥3 months prior to registration (if discontinued, a washout of 2 weeks from prior use is required). Concurrent NSAIDs are allowed if use is limited to <3 times per week; chronic NSAIDs are permitted on study only if use has been ≥3 times per week for at least 3 months prior to registration and is expected to continue.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer Sheng

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Adaptive Nutrition and Exercise Weight Loss (A-NEW) Study

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