NCT01222858

Brief Summary

The proposed project addresses the significant problem of obesity and uses innovative technology to improve adherence to a behavioral weight loss strategies. If the program is effective, it would provide an outstanding resource for physicians to use with their patients and thus would have tremendous clinical impact.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

2.8 years

First QC Date

October 15, 2010

Last Update Submit

July 7, 2014

Conditions

Keywords

ObesityPrimary CareInternetTechnologyBehavior Modification

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    Amount of weight lost (kg) from initial body weight at study entry.

    Baseline, 3-mos, 6-mos

Study Arms (2)

Internet Education Program

ACTIVE COMPARATOR

Participants receive 12 weekly Internet-based weight loss lessons containing information for modification of diet and activity behaviors.

Behavioral: Diet and Activity Education

Innovative Technology Intervention

EXPERIMENTAL

Participants receive a 12-week Internet-based eating and activity intervention including multimedia lessons and enhanced self-monitoring of weight loss behaviors with automated feedback.

Behavioral: Diet and Activity EducationBehavioral: Self-monitoring with Feedback

Interventions

Education about behavioral modification of eating and activity habits for weight loss.

Innovative Technology InterventionInternet Education Program

Participants self-monitor diet and activity behaviors, which are submitted via a website. Automated feedback on the self-monitoring record is provided to participants.

Innovative Technology Intervention

Eligibility Criteria

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

You may qualify if:

  • BMI between 25 and 45 kg/m2
  • Referred by their physician because of an obesity-related co-morbidity, such as diabetes, hypertension or metabolic syndrome
  • All ethnic groups will be recruited
  • No health problems that make weight loss or unsupervised exercise unsafe
  • English speaking
  • Have access to a computer and the Internet

You may not qualify if:

  • report a heart condition, chest pain during periods of activity or rest, or loss of consciousness
  • 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 participated in a study conducted by the Weight Control \& Diabetes Research Center in the past 2 years

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

Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Rena R. Wing, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 15, 2010

First Posted

October 18, 2010

Study Start

August 1, 2010

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

July 8, 2014

Record last verified: 2014-07

Locations