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Internet Assisted Obesity Treatment Enhanced With Financial Incentives (iREACH3)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet Only
Internet + Incentives
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring weight loss, financial incentives, internet weight loss

Eligibility Criteria

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

Inclusion Criteria:

  • over 18
  • BMI between 25 and 50
  • Not currently pregnant or pregnant in the previous 6 months and currently breastfeeding or planning on becoming pregnant in 18 months
  • Have a computer at home or at work with flashplayer, access to the internet, and a smart phone (to allow use of step counting aps)
  • Free of medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
  • Not enrolled in another weight reduction program
  • Not currently on medication that would affect weight loss

Exclusion Criteria:

  • had a heart attack or stroke in the previous six months
  • had weight loss surgery
  • lost 10 pounds or more in the previous 6 months
  • currently taking medications for weight loss
  • required by their doctor to follow a special diet (other than low fat)
  • planning to move out of the area within 18 months
  • schedule conflicts making it difficult to attend online "chats"
  • live more than 60 minutes driving distance from either University of South Carolina or University of Vermont campuses

Sites / Locations

  • University of South Carolina
  • Behavioral Weight Management Program/Univ of Vermont

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Internet only

Internet + Incentives

Arm Description

Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks and monthly for 12 months.

Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting.

Outcomes

Primary Outcome Measures

Weight Change
Weight will be measured at baseline, 2, 6 months. Weight loss at 6 months will be calculated as kg lost from baseline.

Secondary Outcome Measures

Class Attendance
Average number of classes attended
Self Monitoring of Body Weight
Number of days with body weight self reported
Dietary Intake Self Monitoring
Number of days reported dietary intake over 6 months
Self Monitoring of Physical Activity
Number of days physical activity reported
Steps/Day
Number of Steps/day

Full Information

First Posted
February 9, 2016
Last Updated
October 15, 2021
Sponsor
University of Vermont
Collaborators
University of South Carolina, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02688621
Brief Title
Internet Assisted Obesity Treatment Enhanced With Financial Incentives
Acronym
iREACH3
Official Title
Internet Assisted Obesity Treatment Enhanced With Financial Incentives
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 11, 2016 (Actual)
Primary Completion Date
August 2, 2019 (Actual)
Study Completion Date
August 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
University of South Carolina, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators propose a randomized controlled trial to evaluate whether the addition of financial incentives to a high-quality, online behavioral weight loss intervention produces better weight losses than the online treatment alone.
Detailed Description
Overweight and obese but otherwise healthy participants (N=416) will be recruited in approximately equal numbers at two clinical centers, the University of South Carolina and the University of Vermont. Eligible participants will be randomized to one of two conditions: 1) an 18-month, 36-session group Internet behavioral weight control treatment (Internet Only) which replicates the intervention the investigators have implemented previously; or 2) the same 18-month, 36-session group Internet treatment plus financial incentives for performance of 3 key self-management behaviors (Internet+ Incentive). Both conditions will have access to the same web-based intervention platform and the same counselor-delivered intervention elements; the presence of economic incentives for behavioral and weight goals is the only difference between the conditions. Assessments will be conducted at Baseline, 2, 6, 12 and 18 months. Cost data will be collected to inform cost effectiveness evaluations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
weight loss, financial incentives, internet weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
418 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet only
Arm Type
Active Comparator
Arm Description
Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks and monthly for 12 months.
Arm Title
Internet + Incentives
Arm Type
Experimental
Arm Description
Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting.
Intervention Type
Behavioral
Intervention Name(s)
Internet Only
Intervention Description
18 month behavioral weight loss intervention delivered online
Intervention Type
Behavioral
Intervention Name(s)
Internet + Incentives
Intervention Description
18 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing
Primary Outcome Measure Information:
Title
Weight Change
Description
Weight will be measured at baseline, 2, 6 months. Weight loss at 6 months will be calculated as kg lost from baseline.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Class Attendance
Description
Average number of classes attended
Time Frame
6 months
Title
Self Monitoring of Body Weight
Description
Number of days with body weight self reported
Time Frame
6 months
Title
Dietary Intake Self Monitoring
Description
Number of days reported dietary intake over 6 months
Time Frame
6 months
Title
Self Monitoring of Physical Activity
Description
Number of days physical activity reported
Time Frame
6 months
Title
Steps/Day
Description
Number of Steps/day
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: over 18 BMI between 25 and 50 Not currently pregnant or pregnant in the previous 6 months and currently breastfeeding or planning on becoming pregnant in 18 months Have a computer at home or at work with flashplayer, access to the internet, and a smart phone (to allow use of step counting aps) Free of medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component Not enrolled in another weight reduction program Not currently on medication that would affect weight loss Exclusion Criteria: had a heart attack or stroke in the previous six months had weight loss surgery lost 10 pounds or more in the previous 6 months currently taking medications for weight loss required by their doctor to follow a special diet (other than low fat) planning to move out of the area within 18 months schedule conflicts making it difficult to attend online "chats" live more than 60 minutes driving distance from either University of South Carolina or University of Vermont campuses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delia Smith West, PhD
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean R Harvey, PhD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States
Facility Name
Behavioral Weight Management Program/Univ of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35089159
Citation
Stansbury ML, Harvey J, Krukowski RA, Pellegrini CA, Wang X, West DS. Describing Transitions in Adherence to Physical Activity Self-monitoring and Goal Attainment in an Online Behavioral Weight Loss Program: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2022 Jan 28;24(1):e30673. doi: 10.2196/30673.
Results Reference
derived
PubMed Identifier
34932889
Citation
West DS, Krukowski RA, Monroe CM, Stansbury ML, Carpenter CA, Finkelstein EA, Naud S, Ogden D, Harvey JR. Randomized controlled trial of financial incentives during weight-loss induction and maintenance in online group weight control. Obesity (Silver Spring). 2022 Jan;30(1):106-116. doi: 10.1002/oby.23322.
Results Reference
derived
PubMed Identifier
32446752
Citation
West DS, Krukowski RA, Finkelstein EA, Stansbury ML, Ogden DE, Monroe CM, Carpenter CA, Naud S, Harvey JR. Adding Financial Incentives to Online Group-Based Behavioral Weight Control: An RCT. Am J Prev Med. 2020 Aug;59(2):237-246. doi: 10.1016/j.amepre.2020.03.015. Epub 2020 May 21.
Results Reference
derived

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Internet Assisted Obesity Treatment Enhanced With Financial Incentives

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