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Healthy Homes/Healthy Families (HHHF)

Primary Purpose

Chronic Diseases

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Healthy Homes/Healthy Families
Health Education
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Diseases

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Comparison Group

    Intervention'

    Arm Description

    Comparison group participants will be given health education materials.

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Weight
    Self-report weight will be assessed by telephone interview.
    Changes in the home physical and social environment
    A home environment survey will be administered by telephone.

    Full Information

    First Posted
    March 30, 2011
    Last Updated
    January 8, 2016
    Sponsor
    Emory University
    Collaborators
    Centers for Disease Control and Prevention, Cancer Coalition of South Georgia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01326897
    Brief Title
    Healthy Homes/Healthy Families
    Acronym
    HHHF
    Official Title
    Healthy Homes/Healthy Families
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2011 (undefined)
    Primary Completion Date
    July 2013 (Actual)
    Study Completion Date
    July 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Emory University
    Collaborators
    Centers for Disease Control and Prevention, Cancer Coalition of South Georgia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Diseases

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    510 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Comparison Group
    Arm Type
    Active Comparator
    Arm Description
    Comparison group participants will be given health education materials.
    Arm Title
    Intervention'
    Arm Type
    Experimental
    Arm Description
    This group will receive the intervention (Healthy Homes/Healthy Families) as described below.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Healthy Homes/Healthy Families
    Intervention Description
    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
    Intervention Name(s)
    Health Education
    Intervention Description
    Study participants in this group will receive health education materials by mail (3 times over the course of 5 months).
    Primary Outcome Measure Information:
    Title
    Diet & Physical Activity
    Description
    Diet and physical activity will be assessed by telephone interviews. Physical activity will also be assessed using accelerometers at baseline and 6 months.
    Time Frame
    Baseline, 6 months, and 12 months
    Secondary Outcome Measure Information:
    Title
    Weight
    Description
    Self-report weight will be assessed by telephone interview.
    Time Frame
    Baseline, 6 months, and 12 months
    Title
    Changes in the home physical and social environment
    Description
    A home environment survey will be administered by telephone.
    Time Frame
    Baseline, 6 months, and 12 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michelle C Kegler, DrPH, MPH
    Organizational Affiliation
    Emory University, Rollins School of Public Health
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Julie Gazmararian, PhD
    Organizational Affiliation
    Emory University, Rollins School of Public Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26696290
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    24145657
    Citation
    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.
    Results Reference
    derived

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