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OpenTrials
Completed

NCT Number: NCT01326897

Healthy Homes/Healthy Families

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.

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Key information

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy Homes/Healthy Families

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.

Health Education

Behavioral

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

Primary outcomes

  1. Diet & Physical Activity

    Time frame: Baseline, 6 months, and 12 months

    Diet and physical activity will be assessed by telephone interviews. Physical activity will also be assessed using accelerometers at baseline and 6 months.

Secondary outcomes

  1. Weight

    Time frame: Baseline, 6 months, and 12 months

    Self-report weight will be assessed by telephone interview.

  2. Changes in the home physical and social environment

    Time frame: Baseline, 6 months, and 12 months

    A home environment survey will be administered by telephone.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Cancer Coalition of South Georgia
  • Centers for Disease Control and Prevention

Registry information

Acronym: HHHF

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 31, 2011
Registry last updated
Jan 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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