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State-wide Health Approach to Increase Reach and Effectiveness: Study 1 (SHARE)

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ClinicalTrials.gov Identifier: NCT01264393
Recruitment Status : Completed
First Posted : December 21, 2010
Last Update Posted : April 24, 2013
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Rena R. Wing, The Miriam Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Behavioral weight loss programs can successfully reduce body weight, but these programs are available to limited numbers of overweight and obese individuals. This project evaluates a unique weight loss approach that combines a self-sustaining weight loss campaign (for outreach) with training in behavioral weight loss strategies and strategies to increase accountability (to improve weight loss success). This innovative combination has the potential to be a cost-effective model for disseminating weight control interventions.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Shape Up Rhode Island + Online Resources Behavioral: Shape Up Rhode Island + Online Weight Loss Program Behavioral: Shape Up Rhode Island + Online Weight Loss Program + Group sessions Phase 3

Detailed Description:
Participants will be randomly assigned to 1 of 3 treatment arms: Shape Up Rhode Island (SURI; a community-based weight loss campaign), SURI plus an Internet-based behavioral weight loss program (SURI + IBWL), or SURI + IBWL + optional group sessions (SURI + IBWL + Group). Primary outcome is weight loss at 12-weeks.

Study Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 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 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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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 + Online weight loss program + groups
Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention, an internet-based weight loss program, and the option of attending face-to-face group sessions
 Behavioral: Shape Up Rhode Island + Online Weight Loss Program + Group sessions
Participants will receive Shape Up Rhode Island, a 12-week statewide physical activity and weight loss campaign in addition to an online weight loss program and the option of attending group sessions
Active Comparator: Shape Up Rhode Island + Online Weight Loss Program
Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention in addition to an internet-based weight loss program
 Behavioral: Shape Up Rhode Island + Online Weight Loss Program
Participants will receive Shape Up Rhode Island, a 12-week statewide physical activity and weight loss campaign in addition to an online weight loss program
Active Comparator: Shape Up Rhode Island + Internet Resources
Participants in this arm will receive the Standard Shape Up Rhode Island statewide intervention plus access to internet resources
 Behavioral: Shape Up Rhode Island + Online Resources
Participants will receive Shape Up Rhode Island, which is a 12-week statewide physical activity and weight loss campaign in addition to online weight loss resources


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Weight change from the 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 Measures :
  1. Weight change from the initial assessment to the 6-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram. [ Time Frame: 0 to 6 months ]
  2. Weight change from the initial assessment to the 12-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram. [ Time Frame: 0 to 12-months ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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. age 18-70 years
  2. Body Mass Index >25 kg/m2
  3. Both genders will be recruited; it is estimated that 70% of participants will be women.
  4. All ethnic groups will be recruited, with a goal of recruiting 33% minorities (see below for specific recruitment plans)
  5. No health problems that make weight loss or unsupervised exercise unsafe
  6. English speaking

Exclusion criteria:

  1. report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4). Individuals endorsing joint problems, prescription medication use or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
  2. are currently pregnant or intend to become pregnant in the next 12 months
  3. are planning to move outside of the state within the next 12 months
  4. have previously participated in the Shape Up Rhode Island 2008 pilot study
Contacts and Locations
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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): NCT01264393


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Rena R. Wing, Professor, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01264393     History of Changes
Other Study ID Numbers: 2054-10
R18DK083248 ( U.S. NIH Grant/Contract )
First Posted: December 21, 2010    Key Record Dates
Last Update Posted: April 24, 2013
Last Verified: April 2013