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Completed

NCT Number: NCT03801174

Using Partners to Enhance Long-Term Weight Loss

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

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

About this study

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 In months 19-24, intervention will be withdrawn to examine sustainability of effects.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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Partner-assisted intervention

Behavioral

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

Behavioral

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 outcomes

  1. Body Weight (kg)

    Time frame: 24 months

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

Secondary outcomes

  1. Caloric Intake (kcal)

    Time frame: 24 months

    average estimated daily intake from ASA24 Dietary Assessment Tool, assessed every 6 months with 24 months as primary endpoint

  2. Physical Activity

    Time frame: 24 months

    average daily steps over past 7 days from Fitbit, assessed every 6 months with 24 months as primary endpoint

Other outcomes

  1. Transformation of Motivation for Diet

    Time frame: 3 months

    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)

  2. Outcome Efficacy for Diet

    Time frame: 3 months

    5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)

  3. Couple Efficacy for Diet

    Time frame: 3 months

    5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)

  4. Social Support for Diet

    Time frame: 3 months

    9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)

  5. Use of Communal Coping Strategies for Diet

    Time frame: 3 months

    5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)

  6. Transformation of Motivation for Physical Activity

    Time frame: 3 months

    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)

  7. Outcome Efficacy for Physical Activity

    Time frame: 3 months

    5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)

  8. Couple Efficacy for Physical Activity

    Time frame: 3 months

    5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)

  9. Social Support for Physical Activity

    Time frame: 3 months

    9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)

  10. Use of Communal Coping Strategies for Physical Activity

    Time frame: 3 months

    5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Duke University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • RTI International

Registry information

Acronym: Partner2Lose

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 11, 2019
Registry last updated
Jun 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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