Healthy Homes, Healthy Habits

Not Applicable

Completed

• Conditions: Obesity; Familial; Obesity; Obesity, Childhood
• Interventions: Behavioral: Home visitation + HABITS program; Behavioral: Standard home visitation program

• Registration Number: NCT03433456
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

Participants will be 140 mothers (\>50% African American; 100% meet federal poverty level) and their children (n=140; 0-4yo at baseline) (total of N=140 mother-child dyads; i.e., 140 mothers + 140 children = 280 total participants) 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 Timeline

• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-02-07
• Study First Posted: 2018-02-14
• Study Start: 2019-12-02
• Primary Completion: 2023-02-27
• Results First Submitted: 2024-02-23
• Results First Submitted QC: 2024-03-27
• Study Completion: 2024-04-24
• Results First Posted: 2024-04-24
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 296

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home visitation + HABITS Program	Standard home visitation 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.
Standard home visitation program	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.
Home visitation + HABITS Program	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.

Primary Outcome Measures

Name	Time	Method
Weight of Mothers	Baseline, 6 months, 12 months	Body weight (kg) at baseline and follow-up assessments.
Weight of Children	Baseline, 6 months, 12 months	Body weight (kg) at baseline and follow-up assessments..

Secondary Outcome Measures

Name	Time	Method
Habit Strength of Targeted Behaviors	Baseline, 6 months, 12 months	Habit strength for caregivers will be assessed using the Self-Reported Habit Index (SRHI) specific to target behaviors on a scale from 1-5 with scores of 5 indicating higher caregiver habit strength for the target behavior.
Household Environment Assessing the Number of Different Food Items Available	Baseline, 6 months, 12 months	Household environment assessing the number of different food items available in the home of the caregiver will be assessed using a modified Home Food Assessment (HFA) relating to the 4 food-related target behaviors (fruits, vegetables, sugary beverages, and fried foods). Higher values indicate more different food items in that category (fruits, vegetables, sugary beverages, and fried foods) are available within the home.
Household Environment Assessing the Number of Different Activity-promoting Items Available	Baseline, 6 months, 12 months	Household environment assessing the number of different activity-promoting items available in the home of the caregiver will be assessed using a modified Home - Inventory Describing Eating and Activity Development (H-IDEA) form. Higher values indicate more availability of different activity-promoting items in the home.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States