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

NCT ID: NCT01264393

Last Updated: 2013-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-03-31

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

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

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

Group Type ACTIVE_COMPARATOR

Shape Up Rhode Island + Online Weight Loss Program

Intervention Type BEHAVIORAL

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

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

Group Type ACTIVE_COMPARATOR

Shape Up Rhode Island + Online Resources

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rena R. Wing

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rena R. Wing, PhD

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital

Locations

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The Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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Wing RR, Crane MM, Thomas JG, Kumar R, Weinberg B. Improving weight loss outcomes of community interventions by incorporating behavioral strategies. Am J Public Health. 2010 Dec;100(12):2513-9. doi: 10.2105/AJPH.2009.183616. Epub 2010 Oct 21.

Reference Type BACKGROUND
PMID: 20966375 (View on PubMed)

Naparstek J, Wing RR, Xu X, Leahey TM. Internet-delivered obesity treatment improves symptoms of and risk for depression. Obesity (Silver Spring). 2017 Apr;25(4):671-675. doi: 10.1002/oby.21773. Epub 2017 Feb 22.

Reference Type DERIVED
PMID: 28224713 (View on PubMed)

Other Identifiers

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R18DK083248

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2054-10

Identifier Type: -

Identifier Source: org_study_id

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