Healthy Homes/Healthy Families

NCT ID: NCT01326897

Last Updated: 2016-01-12

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

PHASE2

Total Enrollment

510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-07-31

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.

Detailed Description

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Conditions

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Chronic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Comparison Group

Comparison group participants will be given health education materials.

Group Type ACTIVE_COMPARATOR

Health Education

Intervention Type BEHAVIORAL

Study participants in this group will receive health education materials by mail (3 times over the course of 5 months).

Intervention'

This group will receive the intervention (Healthy Homes/Healthy Families) as described below.

Group Type EXPERIMENTAL

Healthy Homes/Healthy Families

Intervention Type BEHAVIORAL

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.

Interventions

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Healthy Homes/Healthy Families

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.

Intervention Type BEHAVIORAL

Health Education

Study participants in this group will receive health education materials by mail (3 times over the course of 5 months).

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Cancer Coalition of South Georgia

UNKNOWN

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Michelle C. Kegler

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michelle C Kegler, DrPH, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University, Rollins School of Public Health

Julie Gazmararian, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University, Rollins School of Public Health

References

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Kegler MC, Haardorfer R, Alcantara IC, Gazmararian JA, Veluswamy JK, Hodge TL, Addison AR, Hotz JA. Impact of Improving Home Environments on Energy Intake and Physical Activity: A Randomized Controlled Trial. Am J Public Health. 2016 Jan;106(1):143-52. doi: 10.2105/AJPH.2015.302942.

Reference Type RESULT
PMID: 26696290 (View on PubMed)

Haardorfer R, Alcantara IC, Patil D, Hotz J, Kegler MC. Physical activity profiles of overweight and obese women in rural Georgia. JAMA Intern Med. 2014 Jan;174(1):148-9. doi: 10.1001/jamainternmed.2013.11571. No abstract available.

Reference Type DERIVED
PMID: 24145657 (View on PubMed)

Other Identifiers

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HHHF

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00048222

Identifier Type: -

Identifier Source: org_study_id

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