NCT02688621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
418

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 23, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 11, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2019

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 2, 2021

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

3.3 years

First QC Date

February 9, 2016

Results QC Date

November 20, 2020

Last Update Submit

October 15, 2021

Conditions

Obesity

Keywords

weight lossfinancial incentivesinternet weight loss

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Class Attendance

    6 months

  • Self Monitoring of Body Weight

    6 months

  • Dietary Intake Self Monitoring

    6 months

  • Self Monitoring of Physical Activity

    6 months

  • Steps/Day

    6 months

Study Arms (2)

Internet only

ACTIVE COMPARATOR

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.

Behavioral: Internet Only

Internet + Incentives

EXPERIMENTAL

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.

Behavioral: Internet + Incentives

Interventions

Internet OnlyBEHAVIORAL

18 month behavioral weight loss intervention delivered online

Internet only
Internet + IncentivesBEHAVIORAL

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

Internet + Incentives

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Behavioral Weight Management Program/Univ of Vermont

Burlington, Vermont, 05405, United States

Location

Related Publications (3)

  • 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.

    PMID: 35089159DERIVED

  • 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.

    PMID: 34932889DERIVED

  • 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.

    PMID: 32446752DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Results Point of Contact

Title
Doris Ogden
Organization
University of Vermont
doris.ogden@uvm.edu
802-656-1960

Study Officials

  • Delia Smith West, PhD

    University of South Carolina

    PRINCIPAL INVESTIGATOR

  • Jean R Harvey, PhD

    University of Vermont

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 23, 2016

Study Start

April 11, 2016

Primary Completion

August 2, 2019

Study Completion

August 2, 2019

Last Updated

October 29, 2021

Results First Posted

February 2, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)