Healthy Homes, Healthy Habits (HABITS)

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Obesity, Childhood; Obesity; Familial
• Intervention / Treatment: Behavioral: Home visitation + HABITS program; Behavioral: Standard home visitation program

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 Type: Interventional
• Enrollment (Actual): 296
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 71 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

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

Number of Arms

2

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.	Behavioral: Home visitation + HABITS program; 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.; Behavioral: Standard home visitation program; 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.	Behavioral: Standard home visitation program; 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	Body weight (kg) at baseline and follow-up assessments.	Baseline, 6 months, 12 months
Weight of Children	Body weight (kg) at baseline and follow-up assessments..	Baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Habit Strength of Targeted Behaviors	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.	Baseline, 6 months, 12 months
Household Environment Assessing the Number of Different Food Items Available	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.	Baseline, 6 months, 12 months
Household Environment Assessing the Number of Different Activity-promoting Items Available	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.	Baseline, 6 months, 12 months

Other 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. Scored on a scale from 0-6 with higher values indicated more frequent consumption of that food or engagement in that behavior.	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. Scored from 0-7 with higher values indicated more frequent consumption of food or engagement in the behavior.	Baseline, 6 months, 12 months
Caregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8)	The Personal Health Questionnaire Depression Scale (PHQ-8), a validated self-report measure of depressive symptoms experienced over the past two weeks, will be administered to caregivers. PHQ-8 scores range from 0-24, higher scores indicate higher caregiver depressive symptoms.	Baseline, 6 months, 12 months
Number of Caregivers With Changes to Their Medical History	Self-reported changes to medical history for caregivers (caregiver illnesses, etc.) will be collected.	6 months, 12 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• 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

General Publications

• Salvy SJ, Dutton GR, Borgatti A, Kim YI. Habit formation intervention to prevent obesity in low-income preschoolers and their mothers: A randomized controlled trial protocol. Contemp Clin Trials. 2018 Jul;70:88-98. doi: 10.1016/j.cct.2018.05.015. Epub 2018 May 24.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2019
• Primary Completion (Actual): February 27, 2023
• Study Completion (Actual): April 24, 2024

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: February 7, 2018
• First Posted (Actual): February 14, 2018

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: obesity; childhood obesity; prevention; health disparities; home visitation; low-income; habit
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• 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)?: YES
• IPD Plan Description: With the documented permission of the IRB, the PI may develop a transportable de-identified database, codebook, and mechanism by which data can be shared with qualified investigators. Interested investigators will be asked to complete a standardized request form stating the specific aims of the analyses, the analytic plan, available resources for completing the proposed project, proposed timeline, and goals (i.e., manuscripts, presentations, and/or grant applications). The PI and research team will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to complete the request, and whether data will be adequately protected and managed. If any of these issues are problematic, the PI and research team will attempt to negotiate a fair resolution with the interested investigators and NIMHD program staff.
• 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: No
• Studies a U.S. FDA-regulated device product: No