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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
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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)
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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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