Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Behavioral: Shape Up Rhode Island Behavioral: Shape Up Rhode Island + Professional Coach + Incentives Behavioral: Shape Up Rhode Island + Peer Coach + Incentives Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
Study Start Date : January 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Rena R Wing, PhD The Miriam Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01760486    
Other Study ID Numbers: 211699-11
R18DK083248 ( U.S. NIH Grant/Contract )
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: December 2013