Testing Strategies for Weight Loss, II

NCT00739492 | Completed Phase 1

• 1 other identifier: 01074
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

In the pilot study, Testing Strategies for Weight Loss, we tested two different approaches using financial incentives to encourage weight loss. In the first, we built on previous work showing the effectiveness of 'deposit contracts', in which subjects are given the opportunity to put their own money at risk if they do not lose weight. In this incentive condition, subjects received a direct payment conditional on daily weight loss, and an optional additional payment based on their own contributions to the deposit contract. We matched their contribution 1:1 to make the option of depositing their own money attractive to this predominantly low SES population. In the second approach we built on our own prior work using lotteries to promote drug adherence. In this incentive condition, participants are entered into a daily lottery, and receive any payoffs they earn from the lottery only if they stay on track with their weight-loss goal. Given their popularity in the general population, lotteries hold the promise of providing a cost-effective means of motivating weight loss and making efforts to lose weight more salient to obese patients. Results from this trial indicate significantly higher weight loss in the incentive arms of the trial than in the control group. The low lost to follow-up rates suggest that this approach to providing daily feedback to keep weight loss salient among participants is feasible. Incentive participants who completed the study called in their daily weights an average 95.8% of the time. 17/19 (89.4%) of subjects deposited money in their deposit contracts and 14/17 participants who made initial deposits either held constant or increased their contributions each month. Subjects in both incentive groups lost significantly more weight on average than subjects in the control group (4.0 lbs) (lottery 13.1 lbs, p = 0.015; deposit contract 14.0 lbs, p = 0.003). Of the subjects not lost to follow-up in the two incentive arms (32 out of 38), all of them lost weight. Based on this promising preliminary evidence and supplemental funding from the Hewlett Foundation, we propose an 8-month study with 2 intervention arms to further examine the effect of incentives on long term weight loss success. This study will build on the work to date to examine which intervention is most successful in promoting sustained weight loss. The proposed 3-arm extension will enroll 66 participants from Philadelphia VA with BMIs between 30 and 40, starting with those potential participants who were placed on a waiting list for our previous study after an overwhelming response to the initial mailing.

Conditions

Obesity

Keywords

weight loss, obesity, financial incentives

Outcome Measures

Primary Outcomes (1)

• actual weight loss

  eight months

Study Arms (3)

1

ACTIVE COMPARATOR

deposit based incentive

Behavioral: financial incentives

2

ACTIVE COMPARATOR

deposit based incentive framed with "maintenance" period

Behavioral: financial incentives

3

NO INTERVENTION

Control arm, no financial incentive

Interventions

financial incentives BEHAVIORAL

financial incentives based on attaining weight loss goals

1; 2

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI between 30-40;
• Age between 30-70;
• At least moderately interested in losing weight (Self-reported 3,4, or 5 on 5 point scale)

You may not qualify if:

• Unstable medical conditions that would likely prevent the subject from completing the study;
• Myocardial infarction within 6 months;
• Uncontrolled hypertension, defined as BP\>170 mm Hg systolic or BP\>110 mm Hg diastolic;
• Diabetic using any medicine besides metformin to control blood sugars
• Metastatic cancer;
• Self-report of 6 or more alcoholic beverages per day;
• Severe depression;
• Active substance abuse;
• Schizophrenia
• Inability to read or severe cognitive deficits that would preclude ability to read consent form or fill out surveys).
• Participation in another research study unless copy of consent form obtained and screened for possible confounding of results.
• Those currently enrolled in a weight loss program elsewhere.
• Pregnant women

Sponsors & Collaborators

• University of Pennsylvania: lead
• William and Flora Hewlett Foundation: collaborator

Study Sites (1)

Philadelphia Veterans Administration Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Kevin Volpp, MD PhD

  Philadelphia Veterans Administration Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: August 21, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: January 1, 2010
• Last Updated: December 6, 2016

Record last verified: 2016-12

Locations

US (1)