Healthy Homes, Healthy Habits

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether an intervention targeting healthy habit development reduces the risk and prevalence of obesity in low-income mothers and children. The study intends to evaluate whether the intervention, delivered in the context of home visitation services for low-income families, reduces weight gain and risk factors associated with parent and childhood obesity compared to those receiving standard home visitation services.

Detailed Description
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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.

Official Title
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Leveraging Ongoing Home Visitation Programs to Address Obesity Disparities Among Underserved, Low-Income Mothers and Children

Conditions
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Obesity, Obesity, Childhood, Obesity; Familial

Intervention / Treatment
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* Behavioral: Home visitation + HABITS program
* Behavioral: Standard home visitation program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Caregiver-child dyads will be randomized to either the intervention group (receiving home intervention + HABITS program) or the a control group to receive their standard of care (home intervention without HABITS)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home visitation + HABITS Program<br>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. | Behavioral: Home visitation + HABITS program<br>* 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.<br>Behavioral: Standard home visitation program<br>* 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.<br>|
| Active Comparator: Standard home visitation program<br>Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module. | Behavioral: Standard home visitation program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight of mothers | change in body weight (kg) from baseline to follow-up assessments. | Baseline, 6 months, 12 months | 
| Rate of weight gain of children | Changes in Body weight (kg) from baseline to follow-up assessments. | Baseline, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal eating practices | 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 | 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 | 
| Effects of treatment on habit strength of targeted behaviors | Habit strength will be assessed using the Self-Reported Habit Index (SRHI) specific to target behaviors. | Baseline, 6 months, 12 months | 
| Household environment (HFA) | Household environment assessing availability, accessibility, and visibility of food and activity items will be assessed using a modified Home Food Assessment (HFA) relating to the 5 target behaviors. | Baseline, 6 months, 12 months | 
| Household environment (H-IDEA) | Household environment assessing availability, accessibility, and visibility of food and activity items will be assessed using a modified Home - Inventory Describing Eating and Activity Development (H-IDEA) form relating to the 5 target habit behaviors. | Baseline, 6 months, 12 months | 
| Personal Health Questionnaire Depression Scale (PHQ-8) | 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 | Self-reported demographic history (gender, age, race, household income, etc) will be collected. | Baseline | 
| Medical history | Self-reported medical history (child and parent/caregiver illnesses, etc.) will be collected. | 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, low-income, health disparities, home visitation, prevention, childhood obesity, habit