Clinical trial NCT02709642: Brigham and Women's Healthy Weight Study
Official title: Brigham and Women's Healthy Weight Study: Randomized Controlled Trial of a Financial Incentive for Weight Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Harvard Pilgrim Health Care
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2016-03-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if a financial deposit contract is a successful method of helping people to maintain their weight loss. A deposit contract is an agreement in which participants put their own money at risk, with the goal of "earning" it back by achieving a goal, in this case maintaining prior weight loss. The study will also evaluate the interventions using survey research to assess the feasibility and acceptability of the interventions.

Detailed description: Interested participants who can verify \>10lb weight-loss over the last year and a half will be randomly assigned to either the control group, in which they will be asked to attend weekly weigh-ins at Brigham and Women's Hospital (BWH) over the course of a year, or to the deposit contract intervention group. Both the control group and the deposit contract group will complete the weekly weigh-ins for one year. The deposit contract group will additionally have a financial component: these participants will be asked to make a deposit of at least $100 each 10-week period over the course of one year (50 weeks), and can recoup this amount as detailed above. All participants will take baseline and end-of-study surveys.

During an enrollment meeting, study staff will request via an authorization form that participants allow approved members of the research staff to examine their electronic medical record for the duration of the study if they receive their care at a BWH-affiliated practice. This will confirm their \>10lb weight loss.

At the end of every 10-week period, DC participants will receive an email with how much money they recouped. Participants who did not recoup the full amount they deposited must bring in a check to the following weigh-in to cover the difference so that participants have at least $100 deposited for the following 10-week period. Additionally, participants will have the option to use their initial study baseline weight, or be re-weighed for a new baseline weight for the following 10-week period, for which they will then use as their target weight. They will also have the option to increase or decrease their deposit for the upcoming 10-week period as needed.

Each subject may skip non-consecutive weigh-ins without losing their weekly contribution. However, if subjects skip two or more consecutive weekly weigh-ins, participants may only recoup up to one of those skipped weigh-ins if they are successful in their weight management in the week that they return for a weigh-in. Skipped weigh-ins will not roll over into a new 10-week period.

Eligibility criteria: Inclusion Criteria:

* employee of Brigham and Women's Hospital, Dana-Farber Cancer Institute (DFCI), Brigham and Women's Physicians Organization (BWPO), or Partners working at the Francis Street complex of Brigham and Women's Hospital (either part-time or full-time)
* 18 years of age or older
* successfully and intentionally lost at least 10lbs within the past 18 months
* had a BMI over 25 at some point over the previous 18 months

Exclusion Criteria:

* plan to change jobs outside of the BWH Francis Street complex in the next year
* had weight-loss surgery in the past 3 years
* currently on a very low calorie (800 or fewer calories) liquid diet or taking weight loss medicine
* currently have cancer, a severe psychiatric disorder, an eating disorder, or another severe medical illness that may affect weight beyond control
* plan to become pregnant in the next year

Primary outcomes:
measure: Weight
timeFrame: Weekly weigh-ins from baseline until the end of the study (about 1 year from April 2016-August 2017).
Secondary outcomes:
measure: Success in meeting weight goal
timeFrame: Weekly weigh-ins from baseline until the end of the study (about 1 year from April 2016-August 2017).
measure: Number of weeks in which subjects met their weight goal
timeFrame: Weekly weigh-ins from baseline until the end of the study (about 1 year from April 2016-August 2017).
measure: Number of participants who report factors of weight maintenance success as assessed by questionnaires
timeFrame: At Baseline (~April-August 2016) and at completion (~June-August 2017)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Obesity Prevention Program, Department of Population Medicine, Harvard Medical School, Harvard Pilgrim Health Care Institute, Boston, MA.
name: Jason P Block, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive-based approaches for weight loss: a randomized trial. JAMA. 2008 Dec 10;300(22):2631-7. doi: 10.1001/jama.2008.804.
citation: Jeffery RW, Thompson PD, Wing RR. Effects on weight reduction of strong monetary contracts for calorie restriction or weight loss. Behav Res Ther. 1978;16(5):363-9. doi: 10.1016/0005-7967(78)90005-0. No abstract available.