Healthy Homes/Healthy Families (HHHF)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Diseases
• Intervention / Treatment: Behavioral: Health Education; Behavioral: Healthy Homes/Healthy Families

• Study Type: Interventional
• Enrollment (Actual): 510
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Comparison Group; Comparison group participants will be given health education materials.	Behavioral: Health Education; Study participants in this group will receive health education materials by mail (3 times over the course of 5 months).
Experimental: Intervention'; This group will receive the intervention (Healthy Homes/Healthy Families) as described below.	Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Centers for Disease Control and Prevention; Cancer Coalition of South Georgia
• Investigators: Principal Investigator: Michelle C Kegler, DrPH, MPH, Emory University, Rollins School of Public Health; Principal Investigator: Julie Gazmararian, PhD, Emory University, Rollins School of Public Health

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: March 30, 2011
• First Submitted That Met QC Criteria: March 30, 2011
• First Posted (Estimate): March 31, 2011

Study Record Updates

• Last Update Posted (Estimate): January 12, 2016
• Last Update Submitted That Met QC Criteria: January 8, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: IRB00048222; HHHF (Other Identifier: Other)