Incentivizing Behavior Change Skills to Promote Weight Loss

Obesity Clinical Trial

Official title:

Incentivizing Behavior Change Skills to Promote Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02691260
• Other study ID #: Pro00056410
• Secondary ID: 1R34HL125669-01A
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: May 2018

Study information

• Verified date: August 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• incentives for dietary self-monitoring
Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application.
• incentives for interim weight loss
Participants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly.
• incentives for both
Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application and for losing an expected amount of weight based on weight obtained weekly.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Voils CI, Levine E, Gierisch JM, Pendergast J, Hale SL, McVay MA, Reed SD, Yancy WS Jr, Bennett G, Strawbridge EM, White AC, Shaw RJ. Study protocol for Log2Lose: A feasibility randomized controlled trial to evaluate financial incentives for dietary self- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Change From Baseline to 24 Weeks	Measured in pounds	24 weeks