Clinical trial NCT03801174: Using Partners to Enhance Long-Term Weight Loss
Official title: Using Partners to Enhance Long-Term Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Duke University
name: RTI International
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-01-11
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 In months 19-24, intervention will be withdrawn to examine sustainability of effects.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

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)

Primary outcomes:
measure: Body Weight (kg)
timeFrame: 24 months
Secondary outcomes:
measure: Caloric Intake (kcal)
timeFrame: 24 months
measure: Physical Activity
timeFrame: 24 months
Other outcomes:
measure: Transformation of Motivation for Diet
timeFrame: 3 months
measure: Outcome Efficacy for Diet
timeFrame: 3 months
measure: Couple Efficacy for Diet
timeFrame: 3 months
measure: Social Support for Diet
timeFrame: 3 months
measure: Use of Communal Coping Strategies for Diet
timeFrame: 3 months
measure: Transformation of Motivation for Physical Activity
timeFrame: 3 months
measure: Outcome Efficacy for Physical Activity
timeFrame: 3 months
measure: Couple Efficacy for Physical Activity
timeFrame: 3 months
measure: Social Support for Physical Activity
timeFrame: 3 months
measure: Use of Communal Coping Strategies for Physical Activity
timeFrame: 3 months
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Corrine Voils, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.