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Avanzando Juntas: Adapting an Evidence Based Weight Loss Program for Hispanic Breast Cancer Survivors

Primary Purpose

Breast Cancer, Gynecologic Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided Lifestyle Program Intervention
Self-Guided Lifestyle Program (Control Arm)
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

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

Inclusion Criteria:

  1. Self-identify as Hispanic or Latina
  2. Female
  3. Stage 0 -III Breast and Gynecological cancer survivors
  4. Treatment (surgery, chemotherapy and/or radiation) completed at least three months before recruitment (ongoing hormonal therapy is acceptable)
  5. Age >18 at time of diagnosis
  6. BMI at least 25 kg/m2 BMI between 25 and 55 - chosen because this will include only those participants who are overweight and would not be harmed by a 5% weight loss

Exclusion Criteria:

  1. Plans to move from the community during the study
  2. A medical condition limiting adherence to diet or physical activity components
  3. History of significant mental illness
  4. Currently pregnant, less than 3 months post-partum, or pregnancy anticipated during the study
  5. Taking any medications prescribed by a doctor to lose weight participate in any organized weight loss programs or has undergone weight loss surgery or planning to undergo weight loss surgery in the next year

Sites / Locations

  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Guided Lifestyle Program

Self-Guided Lifestyle Program

Arm Description

The Intervention will be conducted in a cohort of 20 (anticipated) and is designed to increase self-efficacy, social support and perceived access to healthy eating and exercise resources and promote weight loss. Participants assigned to the Guided Lifestyle Program will participate in twice weekly sessions - the first weekly session will be 120 minutes in length with the first hour addressing lifestyle change education and strategies. The second hour will be supervised exercise including aerobics and resistance training. The second weekly session will be a one-hour supervised exercise session. Participants will also receive 2-3 text messages weekly.They will also receive a participant informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines.The Guided Lifestyle program is four months long (16 weeks). Please note, the Guided Lifestyle program participants will be offered a booster session off-study.

In the self-guided weight loss program, participants will be given the sane informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines but they will not receive in-person classes or text messaging. The study team will call these participants once a month to check in.

Outcomes

Primary Outcome Measures

Change in body composition
Ratio of percent lean mass to percent adiposity as measured by Bio-electrical Impedance Analysis Scale. More lean mass and less adiposity is favorable
Change in intake of fruits and vegetables
ASA24 dietary analysis of self reported food consumption
Change of intake of red meat/processed meat
ASA24 dietary analysis of self reported food consumption
Change in levels of physical activity- minutes per week
Change of ActiGraph monitored activity
Change in levels of physical activity- #times per week
Change of ActiGraph monitored activity
Change in resistance training- Handgrip strength
Jamar Plus Digital Hand Dynamometer
Change in resistance training- Strength and endurance
30-Second Chair Stand (Sit to Stand)
Change in Quality of Life- PROMIS (Patient Reported Outcomes Measurement Information System)
Patient Reported Outcomes Measurement Information System (PROMIS) T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. PROMIS measures physical function, depression, anxiety, fatigue, sleep disturbance, social roles, pain interference, social isolation, cognitive function, support, self-efficacy and sexual function. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like pain interference, a T-score of 60 is one SD worse than average. By comparison, a pain interference T-score of 40 is one SD better than average.
Changes in Systolic and Diastolic Blood Pressure
Participants systolic and diastolic blood pressure will be measured using a digital, automated unit
Change in Biomarkers- Lipids
Lipid blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- Glycohem
Glycohem blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- Glucose
Glucose blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- C-Peptide
C-Peptide blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- Insulin
Insulin blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- hs CRP
hs CRP blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Adipokines- Adiponectin
Adiponectin blood tests
Change in Biomarkers-Adipokines- Leptin
Adiponectin blood tests
Change in waist circumference
Change in waist circumference measurement

Secondary Outcome Measures

Full Information

First Posted
February 26, 2020
Last Updated
December 14, 2022
Sponsor
Medical College of Wisconsin
Collaborators
Loyola University Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT04321135
Brief Title
Avanzando Juntas: Adapting an Evidence Based Weight Loss Program for Hispanic Breast Cancer Survivors
Official Title
Avanzando Juntas: Adapting an Evidence Based Weight Loss Program for Hispanic Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Loyola University Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study examine the feasibility and efficacy of Avanzando Juntas, a four-month community-based lifestyle intervention rooted in the evidence-based Moving Forward lifestyle intervention developed with and for AA breast cancer survivors. This intervention was adapted in collaboration with Hispanic/Latina BC & GC survivors. It will offer twice-weekly sessions aimed at supporting adherence to ACS nutrition and physical activity guidelines to promote weight loss and improved quality of life.
Detailed Description
Aim 1. To adapt the Moving Forward weight loss intervention for overweight/obese Hispanic BCS using an iterative process engaging Hispanic BCS and a community advisory committee. Aim 2. To conduct a randomized pilot with 40 overweight/obese Hispanic BCS to establish the feasibility of the adapted Moving Forward program based on recruitment, adherence, retention and efficacy. Aim 3. To explore the effects of the adapted Moving Forward program (Avanzando Juntas) on anthropometric (weight, % body fat, lean mass), behavioral (dietary intake, physical activity) psychosocial (quality of life) and biological (cholesterol, hemoglobin A1c, adiponectin, leptin, inflammation, insulin resistance) outcomes. Hypothesis: Women in the weight loss program will exhibit improvements in outcomes compared to women in the wait list control group. Avanzando Juntas supports BC & GC survivors in adopting physical activity and eating patterns to promote weight loss, bolster QOL and reduce the risk for comorbidities and, potentially, BC & GC recurrence. A strong, multidisciplinary study team provides expertise in culturally competent programs for Hispanic BCS, cognitive behavioral lifestyle interventions, body composition, breast cancer and program adaptation. This study is novel in its focus on weight loss among Hispanic BCS and the incorporation of anthropometric, behavioral, biological and psychosocial outcomes. An additional strength is the foundation of community partnerships that will support the current study's efforts, as well as those for a larger trial, and, if successful, the dissemination of the program.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to either a guided or self-guided lifestyle intervention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guided Lifestyle Program
Arm Type
Experimental
Arm Description
The Intervention will be conducted in a cohort of 20 (anticipated) and is designed to increase self-efficacy, social support and perceived access to healthy eating and exercise resources and promote weight loss. Participants assigned to the Guided Lifestyle Program will participate in twice weekly sessions - the first weekly session will be 120 minutes in length with the first hour addressing lifestyle change education and strategies. The second hour will be supervised exercise including aerobics and resistance training. The second weekly session will be a one-hour supervised exercise session. Participants will also receive 2-3 text messages weekly.They will also receive a participant informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines.The Guided Lifestyle program is four months long (16 weeks). Please note, the Guided Lifestyle program participants will be offered a booster session off-study.
Arm Title
Self-Guided Lifestyle Program
Arm Type
Active Comparator
Arm Description
In the self-guided weight loss program, participants will be given the sane informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines but they will not receive in-person classes or text messaging. The study team will call these participants once a month to check in.
Intervention Type
Behavioral
Intervention Name(s)
Guided Lifestyle Program Intervention
Intervention Description
The Guided Lifestyle Program will receive sessions that meet twice weekly and 2-3 text messages weekly.They will also receive a participant informational binder (wellness guide) with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines.
Intervention Type
Behavioral
Intervention Name(s)
Self-Guided Lifestyle Program (Control Arm)
Intervention Description
In the self-guided weight loss program, participants will be given the sane informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines but they will not receive in-person classes or text messaging
Primary Outcome Measure Information:
Title
Change in body composition
Description
Ratio of percent lean mass to percent adiposity as measured by Bio-electrical Impedance Analysis Scale. More lean mass and less adiposity is favorable
Time Frame
Baseline to 4 month
Title
Change in intake of fruits and vegetables
Description
ASA24 dietary analysis of self reported food consumption
Time Frame
Baseline to 4 month
Title
Change of intake of red meat/processed meat
Description
ASA24 dietary analysis of self reported food consumption
Time Frame
Baseline to 4 month
Title
Change in levels of physical activity- minutes per week
Description
Change of ActiGraph monitored activity
Time Frame
Baseline to 4 month
Title
Change in levels of physical activity- #times per week
Description
Change of ActiGraph monitored activity
Time Frame
Baseline to 4 month
Title
Change in resistance training- Handgrip strength
Description
Jamar Plus Digital Hand Dynamometer
Time Frame
Baseline to 4 month
Title
Change in resistance training- Strength and endurance
Description
30-Second Chair Stand (Sit to Stand)
Time Frame
Baseline to 4 month
Title
Change in Quality of Life- PROMIS (Patient Reported Outcomes Measurement Information System)
Description
Patient Reported Outcomes Measurement Information System (PROMIS) T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. PROMIS measures physical function, depression, anxiety, fatigue, sleep disturbance, social roles, pain interference, social isolation, cognitive function, support, self-efficacy and sexual function. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like pain interference, a T-score of 60 is one SD worse than average. By comparison, a pain interference T-score of 40 is one SD better than average.
Time Frame
Baseline to 4 month
Title
Changes in Systolic and Diastolic Blood Pressure
Description
Participants systolic and diastolic blood pressure will be measured using a digital, automated unit
Time Frame
Baseline to 4 month
Title
Change in Biomarkers- Lipids
Description
Lipid blood tests measured by Wisconsin Diagnostic Laboratory
Time Frame
Baseline to 4 month
Title
Change in Biomarkers- Glycohem
Description
Glycohem blood tests measured by Wisconsin Diagnostic Laboratory
Time Frame
Baseline to 4 month
Title
Change in Biomarkers- Glucose
Description
Glucose blood tests measured by Wisconsin Diagnostic Laboratory
Time Frame
Baseline to 4 month
Title
Change in Biomarkers- C-Peptide
Description
C-Peptide blood tests measured by Wisconsin Diagnostic Laboratory
Time Frame
Baseline to 4 month
Title
Change in Biomarkers- Insulin
Description
Insulin blood tests measured by Wisconsin Diagnostic Laboratory
Time Frame
Baseline to 4 month
Title
Change in Biomarkers- hs CRP
Description
hs CRP blood tests measured by Wisconsin Diagnostic Laboratory
Time Frame
Baseline to 4 month
Title
Change in Biomarkers-Adipokines- Adiponectin
Description
Adiponectin blood tests
Time Frame
Baseline to 4 month
Title
Change in Biomarkers-Adipokines- Leptin
Description
Adiponectin blood tests
Time Frame
Baseline to 4 month
Title
Change in waist circumference
Description
Change in waist circumference measurement
Time Frame
Baseline to 4 month

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female Breast and Gynecological study participants
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Self-identify as Hispanic or Latina Female Stage 0 -III Breast and Gynecological cancer survivors Treatment (surgery, chemotherapy and/or radiation) completed at least three months before recruitment (ongoing hormonal therapy is acceptable) Age >18 at time of diagnosis BMI at least 25 kg/m2 BMI between 25 and 55 - chosen because this will include only those participants who are overweight and would not be harmed by a 5% weight loss Exclusion Criteria: Plans to move from the community during the study A medical condition limiting adherence to diet or physical activity components History of significant mental illness Currently pregnant, less than 3 months post-partum, or pregnancy anticipated during the study Taking any medications prescribed by a doctor to lose weight participate in any organized weight loss programs or has undergone weight loss surgery or planning to undergo weight loss surgery in the next year
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Avanzando Juntas: Adapting an Evidence Based Weight Loss Program for Hispanic Breast Cancer Survivors

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