Healthy Homes/Healthy Families (HHHF)

This study has been completed.
Sponsor:
Collaborators:
Southwest Georgia Cancer Coalition
Information provided by (Responsible Party):
Michelle C. Kegler, Emory University
ClinicalTrials.gov Identifier:
NCT01326897
First received: March 30, 2011
Last updated: November 19, 2013
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Chronic Diseases
Behavioral: Healthy Homes/Healthy Families
Behavioral: Health Education
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Healthy Homes/Healthy Families

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Diet & Physical Activity [ Time Frame: Baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]
    Diet and physical activity will be assessed by telephone interviews. Physical activity will also be assessed using accelerometers at baseline and 6 months.


Secondary Outcome Measures:
  • Weight [ Time Frame: Baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]
    Self-report weight will be assessed by telephone interview.

  • Changes in the home physical and social environment [ Time Frame: Baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]
    A home environment survey will be administered by telephone.


Enrollment: 510
Study Start Date: February 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326897

Sponsors and Collaborators
Emory University
Southwest Georgia Cancer Coalition
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
  More Information

No publications provided by Emory University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michelle C. Kegler, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01326897     History of Changes
Other Study ID Numbers: IRB00048222, HHHF
Study First Received: March 30, 2011
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014