NCT00644202

Brief Summary

The purpose of this study is to examine how adults can improve their physical activity levels and eating habits using an interactive web-based weight control program and regular contact with a dietician.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started May 2006

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

2 active sites

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

May 1, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
Last Updated

March 26, 2008

Status Verified

March 1, 2008

Enrollment Period

9 months

First QC Date

March 20, 2008

Last Update Submit

March 20, 2008

Conditions

Obesity

Keywords

weight control

Outcome Measures

Primary Outcomes (1)

  • Weight

    24 weeks

Secondary Outcomes (3)

  • Blood pressure

    24 weeks

  • Diet

    24 weeks

  • Physical activity

    24 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Intervention Group

Behavioral: Counseling SessionsBehavioral: Specialized WebsiteBehavioral: Telephone Counseling Calls

Group 2

NO INTERVENTION

Usual Care Group

Interventions

Counseling SessionsBEHAVIORAL

Counseling Sessions at each study visit around diet and physical activity from a registered dietician

Group 1
Specialized WebsiteBEHAVIORAL

Specialized website that allows participants to track their eating and physical activity patterns, learn new weight management skills, interact with the dietician, and receive support from other participants

Group 1
Telephone Counseling CallsBEHAVIORAL

5 telephone calls with a health counselor, lasting 15-20 minutes each.

Group 1

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 65 years of age
  • Body mass index between 30-40 kg/m2
  • Non-smoker (quit within previous 6 months)
  • Comfort reading and speaking English
  • Stage 1 hypertension
  • Not currently pregnant
  • Regular web access from home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Department of Ambulatory Care and Prevention

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Gary Bennett, Ph.D

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 20, 2008

First Posted

March 26, 2008

Study Start

May 1, 2006

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

March 26, 2008

Record last verified: 2008-03

Locations

US(2)