Healthy Homes/Healthy Families

Study Overview
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Brief Summary
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The purpose of the study is to learn how to make homes more supportive of healthy eating and physical activity. As part of the study, participants will be randomly assigned to one of two groups. One group will receive materials with information on healthy eating and physical activity. The materials will be mailed 3 times over a 5 month period. The other group will work with a coach to make their homes more supportive of healthy eating and physical activity. Working with a coach involves 3 home visits and 4 coaching telephone calls over a 5 month period. This group will also receive materials by mail 4 different times. All participants will be asked to complete 7 telephone interviews over a 1 year period. Participants will also be asked to wear an accelerometer, a small portable device that tracks movement from physical activity, for 7 days at 2 different points in the study.

Official Title
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Healthy Homes/Healthy Families

Conditions
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Chronic Diseases

Intervention / Treatment
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* Behavioral: Healthy Homes/Healthy Families
* Behavioral: Health Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 35-65 years old BMI greater than or equal to 25 Speak English Must live with at least one other person Live within 30 miles of 1 of 9 clinics referring patients in the study Must have no contraindications for physical activity Must have no contraindications for participating in a medically unsupervised study Exclusion Criteria: 1 person per household

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Comparison Group<br>Comparison group participants will be given health education materials. | Behavioral: Health Education<br>* Study participants in this group will receive health education materials by mail (3 times over the course of 5 months).<br>|
| Experimental: Intervention'<br>This group will receive the intervention (Healthy Homes/Healthy Families) as described below. | Behavioral: Healthy Homes/Healthy Families<br>* Participants in the intervention group will work with coaches to make their homes more supportive of healthy eating and physical activity. Each intervention participant will receive a tailored home environment profile, and will select from a menu of healthy actions to make changes in their home. The intervention will be delivered over the course of 5 months, with 3 home visits, 4 coaching calls, and 4 support mailings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet & Physical Activity | Diet and physical activity will be assessed by telephone interviews. Physical activity will also be assessed using accelerometers at baseline and 6 months. | Baseline, 6 months, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Self-report weight will be assessed by telephone interview. | Baseline, 6 months, and 12 months | 
| Changes in the home physical and social environment | A home environment survey will be administered by telephone. | Baseline, 6 months, and 12 months |