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Using Partners to Enhance Long-Term Weight Loss (Partner2Lose)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Partner-assisted intervention
Patient-only intervention
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (patients):

  • Aged 18-74 years
  • BMI 27-29.9 kg/m2 plus at least one obesity-related comorbidity or BMI >=30 kg/m2
  • Cohabitating and at least daily contact with a spouse/domestic partner
  • Access to reliable transportation
  • Desire to lose weight
  • Speak and read English
  • Agree to attend visits per protocol
  • Score of at least 4 out of 6 on Callahan cognitive screener
  • Able to stand without assistance for weight measurements without assistance
  • Possess individual email address
  • Possess individual smart phone with data and texting plan
  • Able to complete online screener without assistance
  • Able to use a smartphone, tablet or computer with a video camera or webcam and microphone to download apps and to connect to a video conference call without assistance

Exclusion Criteria (patients):

  • Currently or planning to become pregnant or breastfeeding in the study timeframe
  • Weight loss ≥ 5 lb in the month prior to screening
  • Currently enrolled, or enrolled in previous 3 months, in a clinical or research program focusing on lifestyle change that could affect weight
  • Significant dementia, schizophrenia, psychosis, or drug or alcohol abuse
  • Chronic or unstable illness that would limit ability to participate (e.g., recent hospitalization; unstable heart disease in the 6 months prior to screening, chronic kidney disease stage 4 or higher)
  • Living a nursing home or receiving visits from a home health care agency
  • Planning to relocate in the next 2.5 years
  • Current use of prescription or over-the-counter weight loss medications
  • History of bariatric surgery or planning to have bariatric surgery in the study timeframe
  • Impaired hearing
  • Currently receiving, or received in the past 6 months, treatment for cancer other than skin cancer
  • Use of insulin, sulfonylureas, or meglinitides for diabetes
  • High diuretic dose
  • Exertional chest pain, dizziness, or lightheadedness
  • Pain or other condition than prohibits mild-moderate exercise
  • History of ascites requiring paracentesis

Inclusion criteria (partner):

  • Aged 18 or older
  • Willing to participate
  • Access to reliable transportation
  • Speak and read English
  • Score of at least 4 out of 6 on Callahan cognitive screener
  • Possess smart phone with data and texting plan (not shared with index patient)
  • Possess email address (not shared with index patient)
  • Able to complete online screener without assistance

Exclusion criteria (partner):

  • BMI <18.5 kg/m2
  • Significant dementia, schizophrenia, psychosis, or drug or alcohol abuse
  • Residing in a nursing home or receiving home health care
  • Impaired hearing
  • Currently receiving, or received in the past 6 months, treatment for cancer other than skin cancer
  • Chronic or unstable illness that would limit ability to participate (e.g., recent hospitalization; unstable heart disease in the 6 months prior to screening)

Sites / Locations

  • University of Wisconsin-Madison

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Partner-assisted intervention

Patient-only intervention

Arm Description

Patients and partners will receive intervention

Patients will receive intervention

Outcomes

Primary Outcome Measures

Body weight (kg)
Measured on a calibrated, digital scale to the nearest 0.1 kg, assessed every 6 months with 24 months as primary endpoint

Secondary Outcome Measures

Caloric intake (kcal)
average estimated daily intake from ASA24 Dietary Assessment Tool, assessed every 6 months with 24 months as primary endpoint
Physical activity
average daily minutes of moderate activity over past 7 days from Fitbit, assessed every 6 months with 24 months as primary endpoint

Full Information

First Posted
January 3, 2019
Last Updated
April 4, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
Duke University, RTI International, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03801174
Brief Title
Using Partners to Enhance Long-Term Weight Loss
Acronym
Partner2Lose
Official Title
Using Partners to Enhance Long-Term Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
March 14, 2023 (Actual)
Study Completion Date
March 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Duke University, RTI International, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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 involves an evaluation of the role of domestic partner support in a comprehensive weight loss initiation and maintenance program.
Detailed Description
Couples will be randomized to a comprehensive weight program directed at patients alone or involving their partners. In months 1-6, all patients will receive group-based weight loss program. In months 7-18, all patients will receive a telephone-based weight loss maintenance intervention. In the partner-assisted arm only, partners will participate in the intervention, learning and practicing communication skills and support strategies. In months 19-24, intervention will be withdrawn to examine sustainability of effects. Due to COVID-19, option of doing screening and outcome assessment visits and attending the group classes (including exercise) remotely via a video conference may be available. COVID-19 survey will be administered every 3 month starting at screening/enrollment visit.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
462 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Partner-assisted intervention
Arm Type
Experimental
Arm Description
Patients and partners will receive intervention
Arm Title
Patient-only intervention
Arm Type
Active Comparator
Arm Description
Patients will receive intervention
Intervention Type
Behavioral
Intervention Name(s)
Partner-assisted intervention
Intervention Description
All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Partners will attend some patient group sessions and be informed of patients' goals and relapse plans. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.
Intervention Type
Behavioral
Intervention Name(s)
Patient-only intervention
Intervention Description
All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.
Primary Outcome Measure Information:
Title
Body weight (kg)
Description
Measured on a calibrated, digital scale to the nearest 0.1 kg, assessed every 6 months with 24 months as primary endpoint
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Caloric intake (kcal)
Description
average estimated daily intake from ASA24 Dietary Assessment Tool, assessed every 6 months with 24 months as primary endpoint
Time Frame
24 months
Title
Physical activity
Description
average daily minutes of moderate activity over past 7 days from Fitbit, assessed every 6 months with 24 months as primary endpoint
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Transformation of motivation for diet
Description
Score based on 12-item Unidimensional Relationship Closeness Scale (1-7, strongly disagree to strongly agree) and single-item Inclusion of Other in Self scale (7 Venn diagrams)
Time Frame
3 months
Title
Outcome efficacy for diet
Description
5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)
Time Frame
3 months
Title
Couple efficacy for diet
Description
5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)
Time Frame
3 months
Title
Social support for diet
Description
9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)
Time Frame
3 months
Title
Use of communal coping strategies for diet
Description
5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)
Time Frame
3 months
Title
Transformation of motivation for physical activity
Description
Score based on 12-item Unidimensional Relationship Closeness Scale (1-7, strongly disagree to strongly agree) and single-item Inclusion of Other in Self scale (7 Venn diagrams)
Time Frame
3 months
Title
Outcome efficacy for physical activity
Description
5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)
Time Frame
3 months
Title
Couple efficacy for physical activity
Description
5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)
Time Frame
3 months
Title
Social support for physical activity
Description
9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)
Time Frame
3 months
Title
Use of communal coping strategies for physical activity
Description
5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (patients): Aged 18-74 years BMI 27-29.9 kg/m2 plus at least one obesity-related comorbidity or BMI >=30 kg/m2 Cohabitating and at least daily contact with a spouse/domestic partner Access to reliable transportation Desire to lose weight Speak and read English Agree to attend visits per protocol Score of at least 4 out of 6 on Callahan cognitive screener Able to stand without assistance for weight measurements without assistance Possess individual email address Possess individual smart phone with data and texting plan Able to complete online screener without assistance Able to use a smartphone, tablet or computer with a video camera or webcam and microphone to download apps and to connect to a video conference call without assistance Exclusion Criteria (patients): Currently or planning to become pregnant or breastfeeding in the study timeframe Weight loss ≥ 5 lb in the month prior to screening Currently enrolled, or enrolled in previous 3 months, in a clinical or research program focusing on lifestyle change that could affect weight Significant dementia, schizophrenia, psychosis, or drug or alcohol abuse Chronic or unstable illness that would limit ability to participate (e.g., recent hospitalization; unstable heart disease in the 6 months prior to screening, chronic kidney disease stage 4 or higher) Living a nursing home or receiving visits from a home health care agency Planning to relocate in the next 2.5 years Current use of prescription or over-the-counter weight loss medications History of bariatric surgery or planning to have bariatric surgery in the study timeframe Impaired hearing Currently receiving, or received in the past 6 months, treatment for cancer other than skin cancer Use of insulin, sulfonylureas, or meglinitides for diabetes High diuretic dose Exertional chest pain, dizziness, or lightheadedness Pain or other condition than prohibits mild-moderate exercise History of ascites requiring paracentesis Inclusion criteria (partner): Aged 18 or older Willing to participate Access to reliable transportation Speak and read English Score of at least 4 out of 6 on Callahan cognitive screener Possess smart phone with data and texting plan (not shared with index patient) Possess email address (not shared with index patient) Able to complete online screener without assistance Exclusion criteria (partner): BMI <18.5 kg/m2 Significant dementia, schizophrenia, psychosis, or drug or alcohol abuse Residing in a nursing home or receiving home health care Impaired hearing Currently receiving, or received in the past 6 months, treatment for cancer other than skin cancer Chronic or unstable illness that would limit ability to participate (e.g., recent hospitalization; unstable heart disease in the 6 months prior to screening)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corrine Voils, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36066936
Citation
Miller HN, Voils CI, Cronin KA, Jeanes E, Hawley J, Porter LS, Adler RR, Sharp W, Pabich S, Gavin KL, Lewis MA, Johnson HM, Yancy WS Jr, Gray KE, Shaw RJ. A Method to Deliver Automated and Tailored Intervention Content: 24-month Clinical Trial. JMIR Form Res. 2022 Sep 6;6(9):e38262. doi: 10.2196/38262.
Results Reference
derived
PubMed Identifier
32750431
Citation
Voils CI, Shaw R, Adler R, Jeanes E, Lewis MA, Sharp W, Cronin KA, Hetzel S, Mao L, Johnson HM, Elwert F, Pabich S, Gavin KL, Yancy WS Jr, Porter LS. Protocol for Partner2Lose: A randomized controlled trial to evaluate partner involvement on long-term weight loss. Contemp Clin Trials. 2020 Sep;96:106092. doi: 10.1016/j.cct.2020.106092. Epub 2020 Aug 1.
Results Reference
derived
Links:
URL
http://www.partner2lose.com
Description
Partner2Lose website

Learn more about this trial

Using Partners to Enhance Long-Term Weight Loss

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