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State-wide Health Approach to Increase Reach and Effectiveness: Study 3 (SHARE)

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ClinicalTrials.gov Identifier: NCT01760486
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : January 12, 2016
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
The Miriam Hospital

January 2, 2013
January 4, 2013
January 12, 2016
January 2013
November 2015   (Final data collection date for primary outcome measure)
weight change from month 2 (i.e. immediately following the weight loss phase) to the 12 month follow-up assessment measured on a digital scale to the nearest 0.1 kilogram [ Time Frame: 2 to 12 months ]
Same as current
Complete list of historical versions of study NCT01760486 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
State-wide Health Approach to Increase Reach and Effectiveness: Study 3
Using a State-wide Initiative to Disseminate Effective Behavioral Weight Loss Strategies
The investigators have shown that adding an internet behavioral weight loss program to a statewide campaign improves weight loss outcomes. However, our follow-up data suggest that once the intervention is stopped, participants begin to experience weight regain. Thus, the purpose of this project is extend this line of work and pilot test health coaches and monetary incentives for weight loss maintenance. The investigators hypothesize that coaching and incentives will improve longer-term weight outcomes.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Obesity
  • Behavioral: Shape Up Rhode Island
  • Behavioral: Shape Up Rhode Island + Professional Coach + Incentives
  • Behavioral: Shape Up Rhode Island + Peer Coach + Incentives
  • Active Comparator: Shape Up Rhode Island
    Individuals who join Shape Up Rhode Island 2013, enter our research study, and lose 5% of their initial body weight during the first two months of Shape Up will be randomized to one of the three maintenance interventions. If randomized to this treatment arm, participants will receive periodic newsletters throughout the 12 month trial.
    Intervention: Behavioral: Shape Up Rhode Island
  • Experimental: Shape Up Rhode Island + Professional Coach + Incentives
    Individuals who join Shape Up Rhode Island 2013, enter our research study, and lose 5% of their initial body weight during the first two months of Shape Up will be randomized to one of the three maintenance interventions. If randomized to this treatment arm, participants will receive a professional weight loss coach and will be incentivized for submitting information to their coach and meeting weight goals.
    Intervention: Behavioral: Shape Up Rhode Island + Professional Coach + Incentives
  • Experimental: Shape Up Rhode Island + Peer Coach + Incentives
    Individuals who join Shape Up Rhode Island 2013, enter our research study, and lose 5% of their initial body weight during the first two months of Shape Up will be randomized to one of the three maintenance interventions. If randomized to this treatment arm, participants will receive a peer coach and will be incentivized for reporting to their coach and meeting weight goals.
    Intervention: Behavioral: Shape Up Rhode Island + Peer Coach + Incentives
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
Same as current
November 2015
November 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Body Mass Index >=25kg/m2
  2. English speaking

Exclusion Criteria:

  1. Health problems that make weight loss or unsupervised exercise unsafe
  2. Current pregnancy or plan to become pregnant in the next 12 months
  3. Planned relocation
  4. Previous participation in Shape Up Rhode Island research studies
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01760486
211699-11
R18DK083248 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
The Miriam Hospital
The Miriam Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Rena R Wing, PhD The Miriam Hospital
The Miriam Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP