MedPath

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

Phase 3
Completed
Conditions
Obesity
Interventions
Behavioral: Shape Up Rhode Island + Online Weight Loss Program + Group sessions
Behavioral: Shape Up Rhode Island + Online Weight Loss Program
Behavioral: Shape Up Rhode Island + Online Resources
Registration Number
NCT01264393
Lead Sponsor
The Miriam Hospital
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
500
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
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Shape Up Rhode Island + Online weight loss program + groupsShape Up Rhode Island + Online Weight Loss Program + Group sessionsParticipants 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
Shape Up Rhode Island + Online Weight Loss ProgramShape Up Rhode Island + Online Weight Loss ProgramParticipants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention in addition to an internet-based weight loss program
Shape Up Rhode Island + Internet ResourcesShape Up Rhode Island + Online ResourcesParticipants in this arm will receive the Standard Shape Up Rhode Island statewide intervention plus access to internet resources
Primary Outcome Measures
NameTimeMethod
Weight change from the initial assessment to the 3-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram.0 to 3 months
Secondary Outcome Measures
NameTimeMethod
Weight change from the initial assessment to the 6-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram.0 to 6 months
Weight change from the initial assessment to the 12-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram.0 to 12-months

Trial Locations

Locations (1)

The Miriam Hospital's Weight Control and Diabetes Research Center

🇺🇸

Providence, Rhode Island, United States

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