Healthy Homes/Healthy Families

Chronic Diseases Clinical Trial

— HHHF  

Official title:

Healthy Homes/Healthy Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326897
• Other study ID #: IRB00048222
• Secondary ID: HHHF
• Status: Completed
• Phase: Phase 2
• First received: March 30, 2011
• Last updated: January 8, 2016
• Start date: February 2011
• Est. completion date: July 2013

Study information

• Verified date: January 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	Cancer Coalition of South Georgia, Centers for Disease Control and Prevention

References & Publications (1)

Kegler MC, Haardörfer 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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Weight	Self-report weight will be assessed by telephone interview.	Baseline, 6 months, and 12 months	No
Secondary	Changes in the home physical and social environment	A home environment survey will be administered by telephone.	Baseline, 6 months, and 12 months	No