Using Partners to Enhance Long-Term Weight Loss
Partner2Lose
5 other identifiers
interventional
346
1 country
1
Brief Summary
This study involves an evaluation of the role of domestic partner support in a comprehensive weight loss initiation and maintenance program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jan 2019
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2019
CompletedFirst Posted
Study publicly available on registry
January 11, 2019
CompletedStudy Start
First participant enrolled
January 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2023
CompletedResults Posted
Study results publicly available
June 6, 2024
CompletedJune 6, 2024
May 1, 2024
4.2 years
January 3, 2019
February 6, 2024
May 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Caloric Intake (kcal)
24 months
Physical Activity
24 months
Other Outcomes (10)
Transformation of Motivation for Diet
3 months
Outcome Efficacy for Diet
3 months
Couple Efficacy for Diet
3 months
- +7 more other outcomes
Study Arms (2)
Partner-assisted intervention
EXPERIMENTALPatients and partners will receive intervention
Patient-only intervention
ACTIVE COMPARATORPatients will receive intervention
Interventions
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 Intervention will be withdrawn for the last 6 months to examine sustainability of effects.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- Duke Universitycollaborator
- RTI Internationalcollaborator
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
Study Sites (1)
University of Wisconsin-Madison
Madison, Wisconsin, 53705, United States
Related Publications (4)
Voils CI, Shaw RJ, Gavin KL, Hetzel SJ, Lewis MA, Pabich S, Johnson HM, Elwert F, Mao L, Gray KE, Yuroff A, Garza K, Yancy WS Jr, Porter LS. Outcomes from Partner2Lose: a randomized controlled trial to evaluate 24-month weight loss in a partner-assisted intervention. BMC Public Health. 2024 Jul 20;24(1):1948. doi: 10.1186/s12889-024-19464-z.
PMID: 39033273DERIVEDVoils C, Shaw R, Gavin K, Hetzel S, Lewis M, Pabich S, Johnson H, Elwert F, Mao L, Gray K, Yuroff A, Garza K, Yancy W, Porter L. Primary outcomes from Partner2Lose: A randomized controlled trial to evaluate partner involvement on long-term weight loss. Res Sq [Preprint]. 2024 Mar 11:rs.3.rs-4001003. doi: 10.21203/rs.3.rs-4001003/v1.
PMID: 38559225DERIVEDMiller 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.
PMID: 36066936DERIVEDVoils 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.
PMID: 32750431DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Corrine Voils, PhD
- Organization
- University of Wisconsin - Madison
Study Officials
- PRINCIPAL INVESTIGATOR
Corrine Voils, PhD
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2019
First Posted
January 11, 2019
Study Start
January 15, 2019
Primary Completion
March 14, 2023
Study Completion
March 20, 2023
Last Updated
June 6, 2024
Results First Posted
June 6, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share