Incentivizing Behavior Change Skills to Promote Weight Loss

August 2, 2019 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: no incentives
Participants do not receive financial incentives.
Active Comparator: incentives for dietary self-monitoring
Participants receive financial incentives for dietary self-monitoring.
Behavioral: incentives for dietary self-monitoring
Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application.
Active Comparator: incentives for interim weight loss
Participants receive financial incentives for interim weight loss.
Behavioral: incentives for interim weight loss
Participants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly.
Experimental: incentives for both
Participants receive incentives for dietary self-monitoring and interim weight loss.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Change From Baseline to 24 Weeks
Time Frame: 24 weeks
Measured in pounds
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Ryan J Shaw, PhD, RN, Duke Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

February 22, 2016

First Submitted That Met QC Criteria

February 22, 2016

First Posted (Estimate)

February 25, 2016

Study Record Updates

Last Update Posted (Actual)

August 5, 2019

Last Update Submitted That Met QC Criteria

August 2, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00056410
  • 1R34HL125669-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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