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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01760486
First Posted: January 4, 2013
Last Update Posted: January 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
The Miriam Hospital
  Purpose
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.

Condition Intervention
Obesity Behavioral: Shape Up Rhode Island Behavioral: Shape Up Rhode Island + Professional Coach + Incentives Behavioral: Shape Up Rhode Island + Peer Coach + Incentives

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using a State-wide Initiative to Disseminate Effective Behavioral Weight Loss Strategies

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: January 2013
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
Behavioral: Shape Up Rhode Island + Peer Coach + Incentives

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760486


Locations
United States, Rhode Island
The Miriam Hospital's Weight Control and Diabetes Research Center
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Rena R Wing, PhD The Miriam Hospital
  More Information

Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01760486     History of Changes
Other Study ID Numbers: 211699-11
R18DK083248 ( U.S. NIH Grant/Contract )
First Submitted: January 2, 2013
First Posted: January 4, 2013
Last Update Posted: January 12, 2016
Last Verified: December 2013