Internet Assisted Obesity Treatment Enhanced With Financial Incentives

Obesity Clinical Trial

— iREACH3  

Official title:

Internet Assisted Obesity Treatment Enhanced With Financial Incentives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02688621
• Other study ID #: CHRBS 15-259
• Secondary ID: R01DK056746
• Status: Completed
• Phase: N/A
• Start date: April 11, 2016
• Est. completion date: August 2, 2019

Study information

• Verified date: October 2021
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: August 2, 2019
• Est. primary completion date: August 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Internet Only
18 month behavioral weight loss intervention delivered online
• Internet + Incentives
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

Locations

Country	Name	City	State
United States	Behavioral Weight Management Program/Univ of Vermont	Burlington	Vermont
United States	University of South Carolina	Columbia	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of Vermont	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Change	Weight will be measured at baseline, 2, 6 months. Weight loss at 6 months will be calculated as kg lost from baseline.	6 months
Secondary	Class Attendance	Average number of classes attended	6 months
Secondary	Self Monitoring of Body Weight	Number of days with body weight self reported	6 months
Secondary	Dietary Intake Self Monitoring	Number of days reported dietary intake over 6 months	6 months
Secondary	Self Monitoring of Physical Activity	Number of days physical activity reported	6 months
Secondary	Steps/Day	Number of Steps/day	6 months