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

This study involves an evaluation of the role of domestic partner support in a comprehensive weight loss initiation and maintenance program.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Partner-assisted intervention; Behavioral: Patient-only intervention

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 In months 19-24, intervention will be withdrawn to examine sustainability of effects.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.

• Study Type: Interventional
• Enrollment (Actual): 346
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin-Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Partner-assisted intervention; Patients and partners will receive intervention	Behavioral: Partner-assisted intervention; 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.
Active Comparator: Patient-only intervention; Patients will receive intervention	Behavioral: Patient-only intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caloric Intake (kcal)	average estimated daily intake from ASA24 Dietary Assessment Tool, assessed every 6 months with 24 months as primary endpoint	24 months
Physical Activity	average daily steps over past 7 days from Fitbit, assessed every 6 months with 24 months as primary endpoint	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transformation of Motivation for Diet	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)	3 months
Outcome Efficacy for Diet	5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)	3 months
Couple Efficacy for Diet	5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)	3 months
Social Support for Diet	9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)	3 months
Use of Communal Coping Strategies for Diet	5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)	3 months
Transformation of Motivation for Physical Activity	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)	3 months
Outcome Efficacy for Physical Activity	5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)	3 months
Couple Efficacy for Physical Activity	5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)	3 months
Social Support for Physical Activity	9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)	3 months
Use of Communal Coping Strategies for Physical Activity	5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)	3 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Duke University; RTI International
• Investigators: Principal Investigator: Corrine Voils, PhD, University of Wisconsin, Madison

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Partner2Lose website

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): March 14, 2023
• Study Completion (Actual): March 20, 2023

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (Actual): January 11, 2019

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 2018-1400; A539722 (Other Identifier: UW Madison); SMPH/SURGERY (Other Identifier: UW Madison); 1R01DK111491-01A1 (U.S. NIH Grant/Contract); 2018-1400-CP028 (Other Identifier: Most recent IRB approved protocol)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No