A Pilot Weight Control Intervention at HPHC

Study Overview
=================
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.

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.

Official Title
-----------------
A Pilot Weight Control Intervention at Harvard Pilgrim Health Care (HPHC)

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Counseling Sessions
* Behavioral: Specialized Website
* Behavioral: Telephone Counseling Calls


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Intervention Group | Behavioral: Counseling Sessions<br>* Counseling Sessions at each study visit around diet and physical activity from a registered dietician<br>Behavioral: Specialized Website<br>* 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<br>Behavioral: Telephone Counseling Calls<br>* 5 telephone calls with a health counselor, lasting 15-20 minutes each.<br>|
| No Intervention: Group 2<br>Usual Care Group | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 24 weeks | 
| Diet |  | 24 weeks | 
| Physical activity |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weight control