Incentivizing Behavior Change Skills to Promote Weight Loss

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT02691260
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to determine the feasibility of providing incentives to people enrolled in a weight-loss program for dietary self-monitoring and/or interim weight loss.

Detailed Description

In this study, community outpatients will participate in an effective, 24-week, low-carbohydrate weight loss program delivered via biweekly group classes. An innovative information technology (IT) solution will collate dietary self-monitoring data (input by patients via a mobile phone dietary application) and weight loss data (input by patients via remote scale). An algorithm will classify participants as achieving adequate or inadequate dietary self-monitoring and weight loss to earn intermittent rewards of varying value in real-time. Participants will be notified of earning rewards via text messaging.

Study Timeline

• Study First Submitted: 2016-02-22
• Study First Submitted QC: 2016-02-22
• Study First Posted: 2016-02-25
• Study Start: 2016-04
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Results First Submitted: 2019-05-28
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-02
• Last Update Submitted: 2019-08-02
• Results First Posted: 2019-08-05
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• desire to lose weight;
• agree to attend visits per protocol;
• access to telephone and transportation;
• English speaking;
• able to complete study measures;
• smart phone with data and texting plan;
• body mass index 30 kg/m2 or greater

Exclusion Criteria

• pregnancy, breastfeeding, or lack of birth control if premenopausal
• dementia, excessive alcohol use, or psychiatric illness
• weight loss >4.5 kg in month prior to screening
• weight > 380 lb (due to limit of cellular scale)
• enrollment in other weight loss program
• residing in nursing home or receiving home health care
• unable to attend weight loss group at scheduled times
• impaired hearing
• medication other than metformin, incretin mimetics and incretin enhances for type 2 diabetes
• unstable heart disease in 3 months prior to screening
• furosemide 40 mg or higher (or equivalent)
• chronic kidney disease
• 2 or more errors on cognitive screener
• blood pressure ≥160/100 mmHg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Weight Change From Baseline to 24 Weeks	24 weeks	Measured in pounds

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States