Healthy Homes, Healthy Habits
HABITS
Leveraging Ongoing Home Visitation Programs to Address Obesity Disparities Among Underserved, Low-Income Mothers and Children
2 other identifiers
interventional
296
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Dec 2019
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2018
CompletedFirst Posted
Study publicly available on registry
February 14, 2018
CompletedStudy Start
First participant enrolled
December 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2024
CompletedResults Posted
Study results publicly available
April 24, 2024
CompletedOctober 29, 2024
October 1, 2024
3.2 years
January 31, 2018
February 23, 2024
October 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Habit Strength of Targeted Behaviors
Baseline, 6 months, 12 months
Household Environment Assessing the Number of Different Food Items Available
Baseline, 6 months, 12 months
Household Environment Assessing the Number of Different Activity-promoting Items Available
Baseline, 6 months, 12 months
Other Outcomes (4)
Maternal Eating Practices
Baseline, 6 months, 12 months
Maternal Feeding Practices
Baseline, 6 months, 12 months
Caregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8)
Baseline, 6 months, 12 months
- +1 more other outcomes
Study Arms (2)
Home visitation + HABITS Program
EXPERIMENTALThe 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
ACTIVE COMPARATORParticipants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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:
- years of age at time of enrollment
- Parent or primary caregiver enrolled in First Teacher
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35205, United States
Related Publications (1)
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.
PMID: 29802965BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to COVID-19, there were protocol changes to the study and no data available for some of the 6-month study visits.
Results Point of Contact
- Title
- Dr. Gareth Dutton
- Organization
- University of Alabama at Birmingham
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah J. Salvy, PhD
University of Alabama at Birmingham
- PRINCIPAL INVESTIGATOR
Gareth R. Dutton, PhD
University of Alabama at Birmingham
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 31, 2018
First Posted
February 14, 2018
Study Start
December 2, 2019
Primary Completion
February 27, 2023
Study Completion
April 24, 2024
Last Updated
October 29, 2024
Results First Posted
April 24, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
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.