NCT00948415

Brief Summary

Obesity is a major health problem that has reached epidemic levels. Efforts are needed to develop cost-effective public health approaches for weight loss and maintenance. One such approach is to develop team-based programs that may motivate people to lose weight and/or increase their physical activity. One such program is entitled Shape-up Rhode Island (SURI). The current trial is investigating whether adding both a behavioral intervention delivered online PLUS automated feedback to self-monitoring would enhance the outcomes of SURI participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2009

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

Study Start

First participant enrolled

January 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

1.9 years

First QC Date

July 27, 2009

Last Update Submit

July 7, 2014

Conditions

Obesity

Keywords

ObesityWeight lossInternet

Outcome Measures

Primary Outcomes (1)

  • Weight loss at the end of Shape Up RI

    3 Months

Secondary Outcomes (1)

  • Weight loss maintenance 6 months after program completion

    6 months

Study Arms (2)

SURI Enhanced

EXPERIMENTAL
Behavioral: Evaluation of the Shape Up RI Campaign

SURI Standard

ACTIVE COMPARATOR
Behavioral: Evaluation of the Shape Up RI Campaign

Interventions

Evaluation of the Shape Up RI CampaignBEHAVIORAL

The SURI enhanced group will receive the standard Shape Up RI program. In addition, participants will be asked to record and report their daily calorie intake, body weight, minutes of physical activity, and pedometer steps. Participants will receive automated feedback on progress as well as a behavioral lesson delivered online during each week of the program. Participants assigned to the SURI Standard arm will receive the standard Shape Up RI program. The intervention will take place during the 12-week Shape Up RI campaign.

SURI EnhancedSURI Standard

Eligibility Criteria

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

You may qualify if:

  • Overweight or obese
  • Current participant in the Shape Up RI program weight loss competition

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 27, 2009

First Posted

July 29, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

July 8, 2014

Record last verified: 2014-07

Locations

US(1)