SHARE Study 4: Financial Incentives for Weight Loss
Primary Purpose
Obesity
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Online weight loss + incentives for behavior 3 months
Online weight loss + incentives for weight loss at month 3
Online weight loss + Incentives for behavior 12 months
Online weight loss + Incentives for weight loss 12 months
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- BMI >=25kg/m2
- English speaking
- Age 18-70
Exclusion Criteria:
- Health problems that make weight loss or unsupervised exercise unsafe
- Current pregnancy or plan to become pregnant int he next 12 months
- Planned relocation
- Current participation in weight loss research study
Sites / Locations
- The Miriam Hospital's Weight Control and Diabetes Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Online weight loss + Incentives for behavior 3 months
Online weight loss + Incentives for weight loss 3 months
Online weight loss + Incentives for behavior 12 months
Online weight loss + Incentives for weight loss 12 months
Arm Description
Outcomes
Primary Outcome Measures
weight change from initial assessment to the 3-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram
Secondary Outcome Measures
weight change from the initial assessment to the 12 month assessment measured on a digital scale to the nearest 0.1-kilogram
Weight change from the 3 month assessment to the 12 month assessment measured on a digital scale to the nearest 0.1-kilogram
Full Information
NCT ID
NCT02008474
First Posted
December 6, 2013
Last Updated
August 29, 2016
Sponsor
The Miriam Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT02008474
Brief Title
SHARE Study 4: Financial Incentives for Weight Loss
Official Title
Using a State-wide Initiative to Disseminate Effective Behavioral Weight Loss Strategies: Study 4
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine different types of monetary incentive paradigms for weight loss.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Online weight loss + Incentives for behavior 3 months
Arm Type
Active Comparator
Arm Title
Online weight loss + Incentives for weight loss 3 months
Arm Type
Active Comparator
Arm Title
Online weight loss + Incentives for behavior 12 months
Arm Type
Active Comparator
Arm Title
Online weight loss + Incentives for weight loss 12 months
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Online weight loss + incentives for behavior 3 months
Intervention Description
Participants will receive monetary incentives for submitting their behavior change information into a study website
Intervention Type
Behavioral
Intervention Name(s)
Online weight loss + incentives for weight loss at month 3
Intervention Description
Participants will receive an incentive for meeting their weight loss goal at month 3.
Intervention Type
Behavioral
Intervention Name(s)
Online weight loss + Incentives for behavior 12 months
Intervention Description
Participants will receive incentives for submitting behavior change information over the course of 12 months.
Intervention Type
Behavioral
Intervention Name(s)
Online weight loss + Incentives for weight loss 12 months
Intervention Description
Participants will be receive monetary incentives for reaching their weight loss goal at months 3 and 12.
Primary Outcome Measure Information:
Title
weight change from initial assessment to the 3-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram
Time Frame
0 to 3 months
Secondary Outcome Measure Information:
Title
weight change from the initial assessment to the 12 month assessment measured on a digital scale to the nearest 0.1-kilogram
Time Frame
0 to 12 months
Title
Weight change from the 3 month assessment to the 12 month assessment measured on a digital scale to the nearest 0.1-kilogram
Time Frame
3 to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI >=25kg/m2
English speaking
Age 18-70
Exclusion Criteria:
Health problems that make weight loss or unsupervised exercise unsafe
Current pregnancy or plan to become pregnant int he next 12 months
Planned relocation
Current participation in weight loss research study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rena Wing, PhD
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tricia M Leahey, PhD
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Miriam Hospital's Weight Control and Diabetes Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
SHARE Study 4: Financial Incentives for Weight Loss
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