- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03433456
Healthy Homes, Healthy Habits (HABITS)
Leveraging Ongoing Home Visitation Programs to Address Obesity Disparities Among Underserved, Low-Income Mothers and Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants will be 298 mothers (>50% African American; 100% meet federal poverty level) and their children (0-4yo at baseline) enrolled in our home visitation partner in central Alabama. Home visitors will be randomly assigned to deliver the home visitation curriculum with or without HABITS (an obesity prevention program targeting key eating and activity behaviors) as part of their monthly home visits for 12 months. Treatment sessions for standard of care or standard + HABITS arms will be facilitated by trained home visitors. If a mother or primary caregiver and her child are randomized to participate in the HABITS + Standard home visitation curriculum, they will receive ~15 minutes of information, activities, and assistance regarding the development of key behaviors relating to obesity prevention, which will be imbedded within the existing home visitation curriculum. The HABITS program will address habit-formation of four behaviors relevant to mothers or primary caregivers and children: (1) limit fried foods; (2) limit sugar-sweetened beverages (SSB); (3) increase daily steps; (4) increase fruits and vegetables. Additionally, mothers or primary caregivers will also practice habit formation focused on self-monitoring of weight and the four behaviors previously mentioned. Skill training will focus on habit formation and home environment modification conducive to the four behaviors.
Mothers or primary caregivers in the intervention group will be provided the HABITS + standard home visitation program for 12 months, while those in the control group will be provided the standard home visitation program during this time. Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35205
- University of Alabama at Birmingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
*Important: Mother (or caregiver) and child dyads are enrolled together. Both must meet inclusion criteria to participate.
Mothers or Primary Caregivers:
- Age 18-75 years of age
- Enrollment in First Teacher Home Visiting Program (First Teacher) through the Family Guidance Center of Alabama.
- Mother or primary caregiver of 0-4 year old child
- Generally Healthy
Children:
- 0-4 years of age at time of enrollment
- Parent or primary caregiver enrolled in First Teacher
Exclusion Criteria:
Mothers or primary caregivers:
- Currently enrolled in a diet and weight loss program, AND either a) significant weight loss of 10+ pounds in the last 6 months, OR b) unwilling to discontinue from current diet and weight loss program.
Children:
- Child has a history of a feeding or eating disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Home visitation + HABITS Program
The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.
Participants will receive the HABITS module in addition to their standard home visitation services.
|
The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.
Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
Active Comparator: Standard home visitation program
Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.
|
Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight of mothers
Time Frame: Baseline, 6 months, 12 months
|
change in body weight (kg) from baseline to follow-up assessments.
|
Baseline, 6 months, 12 months
|
Weight of children
Time Frame: Baseline, 6 months, 12 months
|
Change in Body weight (kg) from baseline to follow-up assessments.
|
Baseline, 6 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Habit strength of targeted behaviors
Time Frame: Baseline, 6 months, 12 months
|
Habit strength will be assessed using the Self-Reported Habit Index (SRHI) specific to target behaviors.
|
Baseline, 6 months, 12 months
|
Household environment (HFA)
Time Frame: Baseline, 6 months, 12 months
|
Household environment assessing availability of food items will be assessed using a modified Home Food Assessment (HFA) relating to the 4 food-related target behaviors.
|
Baseline, 6 months, 12 months
|
Household environment (H-IDEA)
Time Frame: Baseline, 6 months, 12 months
|
Household environment assessing availability of activity items will be assessed using a modified Home - Inventory Describing Eating and Activity Development (H-IDEA) form.
|
Baseline, 6 months, 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal eating practices
Time Frame: Baseline, 6 months, 12 months
|
Assessed using modified food and activity frequency measure from the National Health and Nutrition Examination Survey (NHANES), amended to measure target habit behaviors of feeding and activity.
|
Baseline, 6 months, 12 months
|
Maternal feeding practices
Time Frame: Baseline, 6 months, 12 months
|
Assessed using modified food and activity frequency measure from NHANES, amended to measure target habit behaviors of feeding and activity.
|
Baseline, 6 months, 12 months
|
Personal Health Questionnaire Depression Scale (PHQ-8)
Time Frame: Baseline, 6 months, 12 months
|
The PHQ-8, a validated self-report measure of depressive symptoms experienced over the past two weeks, will be administered.
Range 0-24, higher scores indicate higher depression.
|
Baseline, 6 months, 12 months
|
Demographic History
Time Frame: Baseline
|
Self-reported demographic history (gender, age, race, household income, etc) will be collected.
|
Baseline
|
Medical history
Time Frame: 6 months, 12 months
|
Self-reported medical history (child and parent/caregiver illnesses, etc.) will be collected.
|
6 months, 12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sarah J. Salvy, PhD, University of Alabama at Birmingham
- Principal Investigator: Gareth R. Dutton, PhD, University of Alabama at Birmingham
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000517527
- 2U54MD000502-15 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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