Clinical trial NCT02688621: Internet Assisted Obesity Treatment Enhanced With Financial Incentives
Official title: Internet Assisted Obesity Treatment Enhanced With Financial Incentives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: weight loss
financial incentives
internet weight loss
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: University of South Carolina
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-02-23
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Weight Change
timeFrame: 6 months
Secondary outcomes:
measure: Class Attendance
timeFrame: 6 months
measure: Self Monitoring of Body Weight
timeFrame: 6 months
measure: Dietary Intake Self Monitoring
timeFrame: 6 months
measure: Self Monitoring of Physical Activity
timeFrame: 6 months
measure: Steps/Day
timeFrame: 6 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
city: Burlington
country: United States
facility: Behavioral Weight Management Program/Univ of Vermont
state: Vermont
Study officials:
affiliation: University of South Carolina
name: Delia Smith West, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont
name: Jean R Harvey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.