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

Lifespan

Status and phase: Completed; Phase 3

Conditions: Obesity

Treatments: Behavioral: Shape Up Rhode Island + Online Weight Loss Program + Group sessions; Behavioral: Shape Up Rhode Island + Online Resources; Behavioral: Shape Up Rhode Island + Online Weight Loss Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01264393

R18DK083248 (U.S. NIH Grant/Contract)

2054-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 3 patient groups

Shape Up Rhode Island + Online weight loss program + groups

Active Comparator group

Description:

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

Treatment:

Behavioral: Shape Up Rhode Island + Online Weight Loss Program + Group sessions

Shape Up Rhode Island + Online Weight Loss Program

Active Comparator group

Description:

Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention in addition to an internet-based weight loss program

Treatment:

Behavioral: Shape Up Rhode Island + Online Weight Loss Program

Shape Up Rhode Island + Internet Resources

Active Comparator group

Description:

Participants in this arm will receive the Standard Shape Up Rhode Island statewide intervention plus access to internet resources

Treatment:

Behavioral: Shape Up Rhode Island + Online Resources