Internet Assisted Obesity Treatment Enhanced With Financial Incentives

NCT ID: NCT02688621

Last Updated: 2021-10-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

418 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-11

Study Completion Date

2019-08-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

weight loss financial incentives internet weight loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Internet only

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.

Group Type ACTIVE_COMPARATOR

Internet Only

Intervention Type BEHAVIORAL

18 month behavioral weight loss intervention delivered online

Internet + Incentives

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.

Group Type EXPERIMENTAL

Internet + Incentives

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Internet Only

18 month behavioral weight loss intervention delivered online

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of South Carolina

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Vermont

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jean R. Harvey, PhD, RD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Delia Smith West, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Jean R Harvey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of South Carolina

Columbia, South Carolina, United States

Site Status

Behavioral Weight Management Program/Univ of Vermont

Burlington, Vermont, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35089159 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34932889 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32446752 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01DK056746

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHRBS 15-259

Identifier Type: -

Identifier Source: org_study_id