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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Rena R. Wing, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01264393
First received: December 17, 2010
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose
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 Intervention 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

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Enrollment: 500
Study Start Date: January 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

Responsible Party: Rena R. Wing, Professor, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01264393     History of Changes
Other Study ID Numbers: 2054-10  R18DK083248 
Study First Received: December 17, 2010
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 27, 2016