Using Partners to Enhance Long-Term Weight Loss

Obesity Clinical Trial

— Partner2Lose  

Official title:

Using Partners to Enhance Long-Term Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03801174
• Other study ID #: 2018-1400
• Secondary ID: 1R01DK111491-01A
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: March 20, 2023

Study information

• Verified date: April 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 In months 19-24, intervention will be withdrawn to examine sustainability of effects.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 462
• Est. completion date: March 20, 2023
• Est. primary completion date: March 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Weight Loss

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.
• 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.

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison	Madison	Wisconsin

Sponsors (4)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Duke University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), RTI International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Outcome efficacy for diet	5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)	3 months
Other	Couple efficacy for diet	5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)	3 months
Other	Social support for diet	9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)	3 months
Other	Use of communal coping strategies for diet	5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)	3 months
Other	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
Other	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
Other	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
Other	Social support for physical activity	9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)	3 months
Other	Use of communal coping strategies for physical activity	5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)	3 months
Primary	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	Caloric intake (kcal)	average estimated daily intake from ASA24 Dietary Assessment Tool, assessed every 6 months with 24 months as primary endpoint	24 months
Secondary	Physical activity	average daily minutes of moderate activity over past 7 days from Fitbit, assessed every 6 months with 24 months as primary endpoint	24 months

External Links

•   Partner2Lose website