A Pilot Weight Control Intervention at HPHC

This study has been completed.
Sponsor:
Collaborator:
Harvard Pilgrim Health Care
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00644202
First received: March 20, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Counseling Sessions
Behavioral: Specialized Website
Behavioral: Telephone Counseling Calls

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Weight Control Intervention at Harvard Pilgrim Health Care (HPHC)

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Diet [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: May 2006
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Intervention Group
Behavioral: Counseling Sessions
Counseling Sessions at each study visit around diet and physical activity from a registered dietician
Behavioral: Specialized Website
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
Behavioral: Telephone Counseling Calls
5 telephone calls with a health counselor, lasting 15-20 minutes each.
No Intervention: Group 2
Usual Care Group

Detailed Description:
  • All study participants must have regular access to the Internet, however, the study will not provide this access. Participants will be randomly placed in one of two study groups (Group 1 or Group 2).
  • Group 1 participants will be asked to make 3 in-person visits, each lasting 75-90 minutes. The following information will be collected: name, mailing address, telephone number, and email address. During the study visit, the following measurements will be taken: height, weight, waist circumference, blood pressure and dietary patterns.
  • Group 1 participants will also receive counseling around diet and physical activity from a registered dietician and be asked to use a specialized website that will allow them to track eating and physical activity patterns, learn new weight management skills, interact with the dietician, and receive support from other participants.
  • Group 1 will also receive 5 telephone counseling calls with a health counselor. During the telephone calls, we will teach the participant new skills such as tracking diet and physical activity, goal-setting and staying motivated.
  • Group 2 participants will be asked to make 2 in-person visits, each lasting 75-90 minutes in length. The following information will be collected: your name, mailing address, and telephone number. During the study visit, the following measurements will be taken: height, weight, waist circumference, blood pressure and dietary patterns.
  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 25 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644202

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Department of Ambulatory Care and Prevention
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Harvard Pilgrim Health Care
Investigators
Principal Investigator: Gary Bennett, Ph.D Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Gary Bennett, Ph.D, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00644202     History of Changes
Other Study ID Numbers: 06-007
Study First Received: March 20, 2008
Last Updated: March 20, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
weight control

ClinicalTrials.gov processed this record on September 22, 2014