NCT01326897

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
510

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

2.4 years

First QC Date

March 30, 2011

Last Update Submit

January 8, 2016

Conditions

Chronic Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Weight

    Baseline, 6 months, and 12 months

  • Changes in the home physical and social environment

    Baseline, 6 months, and 12 months

Study Arms (2)

Comparison Group

ACTIVE COMPARATOR

Comparison group participants will be given health education materials.

Behavioral: Health Education

Intervention'

EXPERIMENTAL

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

Behavioral: Healthy Homes/Healthy Families

Interventions

Healthy Homes/Healthy FamiliesBEHAVIORAL

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'
Health EducationBEHAVIORAL

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

Comparison Group

Eligibility Criteria

Age35 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • 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

You may not qualify if:

  • person per household

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 26696290RESULT

  • 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.

    PMID: 24145657DERIVED

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michelle C Kegler, DrPH, MPH

    Emory University, Rollins School of Public Health

    PRINCIPAL INVESTIGATOR

  • Julie Gazmararian, PhD

    Emory University, Rollins School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2011

First Posted

March 31, 2011

Study Start

February 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

January 12, 2016

Record last verified: 2016-01