NCT01560130

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 tests the efficacy of adding components designed to enhance accountability and increase motivation for weight loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3 obesity

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_3 obesity

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

April 24, 2013

Status Verified

April 1, 2013

Enrollment Period

1.1 years

First QC Date

March 20, 2012

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 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 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 + Incentives

ACTIVE COMPARATOR
Behavioral: Shape Up Rhode Island + Online weight loss + Incentives

Shape Up Rhode Island + Online weight loss program

ACTIVE COMPARATOR
Behavioral: Shape Up Rhode Island + Online weight loss program

Shape Up Rhode Island + Online weight loss program + groups

ACTIVE COMPARATOR
Behavioral: Shape Up Rhode Island + Online weight loss program + Groups

Interventions

Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention and an Internet-based behavioral weight loss program.

Shape Up Rhode Island + Online weight loss program

Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention, an Internet-based behavioral weight loss program, and the option to attend group sessions.

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 behavioral weight loss program, and monetary incentives for submitting self-monitoring information and for achieving clinically significant weight loss.

Shape Up Rhode Island + Online Weight Loss + Incentives

Eligibility Criteria

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

You may qualify if:

  • Body mass index \>=25 kg/m2
  • English speaking

You may not qualify if:

  • Health problems that make weight loss or unsupervised exercise unsafe
  • Current pregnancy or plan to become pregnant in the next 12 months
  • Planned relocation
  • Previous participation in Shape Up Rhode Island research studies

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

MeSH Terms

Conditions

Obesity

Interventions

Population Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

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

March 20, 2012

First Posted

March 22, 2012

Study Start

January 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

April 24, 2013

Record last verified: 2013-04

Locations