Internet Assisted Obesity Treatment Enhanced With Financial Incentives

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Internet + Incentives; Behavioral: Internet Only

• Registration Number: NCT02688621
• Lead Sponsor: University of Vermont

Brief Summary

The investigators propose a randomized controlled trial to evaluate whether the addition of financial incentives to a high-quality, online behavioral weight loss intervention produces better weight losses than the online treatment alone.

Detailed Description

Overweight and obese but otherwise healthy participants (N=416) will be recruited in approximately equal numbers at two clinical centers, the University of South Carolina and the University of Vermont. Eligible participants will be randomized to one of two conditions: 1) an 18-month, 36-session group Internet behavioral weight control treatment (Internet Only) which replicates the intervention the investigators have implemented previously; or 2) the same 18-month, 36-session group Internet treatment plus financial incentives for performance of 3 key self-management behaviors (Internet+ Incentive). Both conditions will have access to the same web-based intervention platform and the same counselor-delivered intervention elements; the presence of economic incentives for behavioral and weight goals is the only difference between the conditions. Assessments will be conducted at Baseline, 2, 6, 12 and 18 months. Cost data will be collected to inform cost effectiveness evaluations.

Study Timeline

• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-02-17
• Study First Posted: 2016-02-23
• Study Start: 2016-04-11
• Primary Completion: 2019-08-02
• Study Completion: 2019-08-02
• Results First Submitted: 2020-11-20
• Results First Submitted QC: 2021-01-29
• Results First Posted: 2021-02-02
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-15
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 418

Inclusion Criteria

• over 18
• BMI between 25 and 50
• Not currently pregnant or pregnant in the previous 6 months and currently breastfeeding or planning on becoming pregnant in 18 months
• Have a computer at home or at work with flashplayer, access to the internet, and a smart phone (to allow use of step counting aps)
• Free of medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
• Not enrolled in another weight reduction program
• Not currently on medication that would affect weight loss

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Exclusion Criteria

• had a heart attack or stroke in the previous six months
• had weight loss surgery
• lost 10 pounds or more in the previous 6 months
• currently taking medications for weight loss
• required by their doctor to follow a special diet (other than low fat)
• planning to move out of the area within 18 months
• schedule conflicts making it difficult to attend online "chats"
• live more than 60 minutes driving distance from either University of South Carolina or University of Vermont campuses

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet + Incentives	Internet + Incentives	Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting.
Internet only	Internet Only	Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks and monthly for 12 months.

Primary Outcome Measures

Name	Time	Method
Weight Change	6 months	Weight will be measured at baseline, 2, 6 months. Weight loss at 6 months will be calculated as kg lost from baseline.

Secondary Outcome Measures

Name	Time	Method
Class Attendance	6 months	Average number of classes attended
Self Monitoring of Body Weight	6 months	Number of days with body weight self reported
Dietary Intake Self Monitoring	6 months	Number of days reported dietary intake over 6 months
Self Monitoring of Physical Activity	6 months	Number of days physical activity reported
Steps/Day	6 months	Number of Steps/day

Trial Locations

Locations (2)

Behavioral Weight Management Program/Univ of Vermont; 🇺🇸 Burlington, Vermont, United States

University of South Carolina; 🇺🇸 Columbia, South Carolina, United States