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OpenTrials
Completed

NCT Number: NCT02691260

Incentivizing Behavior Change Skills to Promote Weight Loss

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.

Completed

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Incentives for dietary self-monitoring

Behavioral

Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application.

incentives for interim weight loss

Behavioral

Participants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly.

incentives for both

Behavioral

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.

Primary outcomes

  1. Weight Change From Baseline to 24 Weeks

    Time frame: 24 weeks

    Measured in pounds

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 25, 2016
Registry last updated
Aug 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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