Overview

This trial is active, not recruiting.

Condition obesity
Treatments incentives, environmental strategies
Sponsor University of Pennsylvania
Collaborator Centers for Disease Control and Prevention
Start date September 2014
End date September 2019
Trial size 344 participants
Trial identifier NCT02878343, 821428

Summary

This study will evaluate the comparative effectiveness of behavioral economic financial incentives and environmental strategies, separately and together, in achieving initial weight loss and maintenance of weight loss, in obese employee populations. Our study contributes to the Centers for Disease Control and Prevention's efforts to combat obesity but in particular to the Centers for Disease Control's winnable battles (physical activity and obesity); the National Center for Chronic Disease Prevention and Health Promotion's strategic priorities around well-being, health equity, and evaluation and dissemination of environmental and systems-wide solutions to address public health problems; and the National Center for Chronic Disease Prevention and Health Promotion's domain around healthier work-site initiatives, the Centers for Disease Control and Prevention's efforts to improve nutrition and physical activity to prevent obesity, and reduction of cardiovascular disease risk. This study is a 4-arm randomized controlled trial in which 344 employees of the City of Philadelphia, Independence Blue Cross, and South Eastern Pennsylvania Transportation Authority with initial Body Mass Index of 30 will be randomized to receive one of the following: 1) Daily lottery type incentives tied to achievement of weight loss goals (incentive arm); 2) individually tailored environmental strategies around food intake and physical activity (environmental arm); 3) a combination of incentives and environmental strategies (combined arm); or 4) standard employee wellness benefits and weigh-ins every 6 months (control arm). Phase I of the study (first 6 months) will focus on weight loss; Phase II (months 7-18) will focus on continued weight loss or maintenance for those who choose to maintain weight loss as opposed to continuing to try to lose weight; Phase III (months 19-24) will provide a period of post-intervention follow-up to measure sustainability of effects.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Active Comparator)
Daily lottery type incentives tied to achievement of weight loss goals
incentives
Daily lottery type incentives tied to achievement of weight loss goals
(Active Comparator)
Individually tailored environmental strategies around food intake and physical activity; automated text/emails sent from study website platform
environmental strategies
Individually tailored environmental strategies around food intake and physical activity; automated text/emails sent from study website platform
(Active Comparator)
A combination of incentives and environmental strategies
incentives
Daily lottery type incentives tied to achievement of weight loss goals
environmental strategies
Individually tailored environmental strategies around food intake and physical activity; automated text/emails sent from study website platform
(No Intervention)
Standard employee wellness benefits

Primary Outcomes

Measure
Weight change
time frame: 18 months (baseline until month 18)

Secondary Outcomes

Measure
Costs to implement study arms, relative to effectiveness, for weight loss, including costs associated with incentive payments, administrative costs of program, project personnel costs, medical expenditures, and exercise and counseling services costs.
time frame: 18 months (baseline until month 18)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Men and women > 18 yrs. of age - Full-time or part-time employees at Southeastern Pennsylvania Transportation Authority , Independence Blue Cross, or the City of Philadelphia - BMI of 30 to 55 kg/m2 - Participants must receive their health benefits from Independence Blue Cross; one of our partners in the study Exclusion Criteria: - Unstable heart disease, uncontrolled hypertension, kidney disease, and other serious chronic illness (e.g., transplant recipient, terminal illness) - Substance abuse; bulimia nervosa or related behaviors; or diabetes medication other than metformin - Pregnancy or breast feeding - Contraindications to counseling about diet, physical activity, or weight reduction - Unstable mental illness - Individuals unable to read consent forms or fill out surveys in English will be excluded.

Additional Information

Official title A Randomized Controlled Trial of Incentives Versus Environmental Strategies for Weight Loss
Principal investigator Kevin Volpp, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Pennsylvania.