Chronic DiseasesPhase 2HHHFNCT01326897
Healthy Homes/Healthy Families
A Phase 2 study testing Healthy Homes/Healthy Families and Health Education in people with Chronic Diseases, run by Emory University.
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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Diseases
- What is being tested?
- Healthy Homes/Healthy Families and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Jul 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1 person per household
About this study
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.
- Conditions
- Chronic Diseases
- Being tested
- Healthy Homes/Healthy Families, Health Education
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Homes/Healthy FamiliesBehavioural
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 EducationBehavioural
Study participants in this group will receive health education materials by mail (3 times over the course of 5 months).
| Study group | Role | What they receive |
|---|---|---|
| Comparison Group | Active comparator | Comparison group participants will be given health education materials. Receives: Behavioral: Health Education |
| Intervention' | Experimental | This group will receive the intervention (Healthy Homes/Healthy Families) as described below. Receives: Behavioral: Healthy Homes/Healthy Families |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months, and 12 months
Secondary outcomes (2)
Weight
Self-report weight will be assessed by telephone interview.
Measured: Baseline, 6 months, and 12 months
Changes in the home physical and social environment
A home environment survey will be administered by telephone.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseasesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Cancer Coalition of South Georgia
- Responsible party
- Principal investigator, Michelle C. Kegler, Emory University
- Investigators
- Michelle C Kegler, DrPH, MPH, Principal investigator, Emory University, Rollins School of Public HealthJulie Gazmararian, PhD, Principal investigator, Emory University, Rollins School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326897
- Sponsor's protocol ID
- IRB00048222
- Other IDs
- HHHF
- Acronym
- HHHF
- Status last verified
- Jan 2016
- First submitted
- 30 Mar 2011
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26696290Haardorfer 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.
PubMed 24145657
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Homes/Healthy Families
- ClinicalTrials.gov ID
- NCT01326897
- Acronym / sponsor ID
- HHHF / IRB00048222
- Conditions
- Chronic Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Cancer Coalition of South Georgia
- Study start
- Feb 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 31 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison Group | Active comparator | Behavioral: Health EducationComparison group participants will be given health education materials. |
| Intervention' | Experimental | Behavioral: Healthy Homes/Healthy FamiliesThis group will receive the intervention (Healthy Homes/Healthy Families) as described below. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female
- 35-65 years old
- BMI greater than or equal to 25
- Speak English
- Must live with at least one other person
Key exclusion criteria (1 listed)
- 1 person per household
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Homes/Healthy FamiliesParticipants 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. | Behavioural | Intervention' |
| Health EducationStudy participants in this group will receive health education materials by mail (3 times over the course of 5 months). | Behavioural | Comparison Group |
Primary outcome
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.
2 secondary outcomes
Weight
Time frame: Baseline, 6 months, and 12 months
Changes in the home physical and social environment
Time frame: Baseline, 6 months, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- Results publication: PubMed 26696290Kegler 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.
- Derived from this study: PubMed 24145657Haardorfer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle C Kegler, DrPH, MPH principal investigator
Emory University, Rollins School of Public Health
Julie Gazmararian, PhD principal investigator
Emory University, Rollins School of Public Health
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Healthy Homes/Healthy Families and Health Education in people with Chronic Diseases, run by Emory University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet & Physical Activity (time frame: Baseline, 6 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01326897, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.