NCT01264393

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3 obesity

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2010

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 24, 2013

Status Verified

April 1, 2013

Enrollment Period

2.2 years

First QC Date

December 17, 2010

Last Update Submit

April 23, 2013

Conditions

Outcome Measures

Primary Outcomes (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.

    0 to 3 months

Secondary Outcomes (2)

  • 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

Study Arms (3)

Shape Up Rhode Island + Online weight loss program + groups

ACTIVE COMPARATOR

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

Shape Up Rhode Island + Online Weight Loss Program

ACTIVE COMPARATOR

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

Shape Up Rhode Island + Internet Resources

ACTIVE COMPARATOR

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

Interventions

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

Shape Up Rhode Island + Internet Resources

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 + 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 and the option of attending group sessions

Shape Up Rhode Island + Online weight loss program + groups

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • are currently pregnant or intend to become pregnant in the next 12 months
  • are planning to move outside of the state within the next 12 months
  • have previously participated in the Shape Up Rhode Island 2008 pilot study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

Related Publications (2)

  • 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.

    PMID: 20966375BACKGROUND
  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rena R. Wing, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 17, 2010

First Posted

December 21, 2010

Study Start

January 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 24, 2013

Record last verified: 2013-04

Locations