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Incentivizing Behavior Change Skills to Promote Weight Loss

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ClinicalTrials.gov Identifier: NCT02691260
Recruitment Status : Completed
First Posted : February 25, 2016
Last Update Posted : October 15, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: incentives for dietary self-monitoring Behavioral: incentives for interim weight loss Behavioral: incentives for both Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Incentivizing Behavior Change Skills to Promote Weight Loss
Study Start Date : April 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. weight [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691260


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27701
Sponsors and Collaborators
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Ryan J Shaw, PhD, RN Duke University Health System

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02691260     History of Changes
Other Study ID Numbers: Pro00056410
1R34HL125669-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Duke University:
obesity
behavioral intervention
diet

Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms