A Pilot Weight Control Intervention at HPHC

NCT ID: NCT00644202

Last Updated: 2008-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-02-28

Brief Summary

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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.

Detailed Description

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* 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.

Conditions

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Obesity

Keywords

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weight control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group 1

Intervention Group

Group Type EXPERIMENTAL

Counseling Sessions

Intervention Type BEHAVIORAL

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

Specialized Website

Intervention Type BEHAVIORAL

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

Telephone Counseling Calls

Intervention Type BEHAVIORAL

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

Group 2

Usual Care Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Counseling Sessions

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

Intervention Type 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

Intervention Type BEHAVIORAL

Telephone Counseling Calls

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harvard Pilgrim Health Care

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Dana-Farber Cancer Institute

Principal Investigators

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Gary Bennett, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Department of Ambulatory Care and Prevention

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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06-007

Identifier Type: -

Identifier Source: org_study_id