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Incentivizing Behavior Change Skills to Promote Weight Loss

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
incentives for dietary self-monitoring
incentives for interim weight loss
incentives for both
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, behavioral intervention, diet

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Experimental

Arm Label

no incentives

incentives for dietary self-monitoring

incentives for interim weight loss

incentives for both

Arm Description

Participants do not receive financial incentives.

Participants receive financial incentives for dietary self-monitoring.

Participants receive financial incentives for interim weight loss.

Participants receive incentives for dietary self-monitoring and interim weight loss.

Outcomes

Primary Outcome Measures

Weight Change From Baseline to 24 Weeks
Measured in pounds

Secondary Outcome Measures

Full Information

First Posted
February 22, 2016
Last Updated
August 2, 2019
Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02691260
Brief Title
Incentivizing Behavior Change Skills to Promote Weight Loss
Official Title
Incentivizing Behavior Change Skills to Promote Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, behavioral intervention, diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
no incentives
Arm Type
No Intervention
Arm Description
Participants do not receive financial incentives.
Arm Title
incentives for dietary self-monitoring
Arm Type
Active Comparator
Arm Description
Participants receive financial incentives for dietary self-monitoring.
Arm Title
incentives for interim weight loss
Arm Type
Active Comparator
Arm Description
Participants receive financial incentives for interim weight loss.
Arm Title
incentives for both
Arm Type
Experimental
Arm Description
Participants receive incentives for dietary self-monitoring and interim weight loss.
Intervention Type
Behavioral
Intervention Name(s)
incentives for dietary self-monitoring
Intervention Description
Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application.
Intervention Type
Behavioral
Intervention Name(s)
incentives for interim weight loss
Intervention Description
Participants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly.
Intervention Type
Behavioral
Intervention Name(s)
incentives for both
Intervention Description
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 Measure Information:
Title
Weight Change From Baseline to 24 Weeks
Description
Measured in pounds
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan J Shaw, PhD, RN
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29289702
Citation
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-monitoring and interim weight loss in adults with obesity. Contemp Clin Trials. 2018 Feb;65:116-122. doi: 10.1016/j.cct.2017.12.007. Epub 2017 Dec 28.
Results Reference
result
PubMed Identifier
33245118
Citation
Voils CI, Pendergast J, Hale SL, Gierisch JM, Strawbridge EM, Levine E, McVay MA, Reed SD, Yancy WS, Shaw RJ. A randomized feasibility pilot trial of a financial incentives intervention for dietary self-monitoring and weight loss in adults with obesity. Transl Behav Med. 2021 Apr 26;11(4):954-969. doi: 10.1093/tbm/ibaa102.
Results Reference
derived
PubMed Identifier
30758297
Citation
Shaw R, Levine E, Streicher M, Strawbridge E, Gierisch J, Pendergast J, Hale S, Reed S, McVay M, Simmons D, Yancy W, Bennett G, Voils C. Log2Lose: Development and Lessons Learned From a Mobile Technology Weight Loss Intervention. JMIR Mhealth Uhealth. 2019 Feb 13;7(2):e11972. doi: 10.2196/11972.
Results Reference
derived

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Incentivizing Behavior Change Skills to Promote Weight Loss

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