Digitally Delivered Child Obesity Prevention for Parents in Home Visiting Programs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: digital intervention + home visiting curriculum, Home visiting curriculum.
- Who it may be relevant to
- Registry conditions: Childhood Obesity Prevention. Basic parameters: 16 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Pilot Feasibility Study of Digitally Delivered Modules Focused on Preventing the Development of Obesity During the First Year of Life Within an Existing Statewide Home Visitation Program
Overview
The goal of this clinical trial is to determine feasibility and acceptability of a digitally-based obesity prevention intervention for mothers of infants participating in a home visitation program. The main questions it aims to answer are: * What impact does the digitally based obesity prevention intervention for parents have on children's weight? * What impact does the digitally based obesity prevention intervention have on mothers' feeding practices, child sleep, and child screen time? Researchers will compare the digital intervention to home visiting standard curriculum to see if the intervention results in larger improvements. Participants will view several digital modules including videos on feeding, activity and family topics over the course of 1 year. They will complete questionnaires at the beginning of the study and again at 4, 6 and 12 months and their child will be weighed and measured at each time point.
Detailed description
The first 1,000 days (conception to age 2) have been deemed a critical period for obesity prevention yet, effective, sustainable efforts are lacking. Current home visitation programs (HVP) targeting at-risk families for other child development related issues are a potential innovative opportunity for early childhood obesity prevention. The overall goal of the project is to reduce the prevalence of overweight and obesity in children under the age of 1 year thereby reducing obesity rates of older children and adults in the long term. Prior pilot work by members of the research team demonstrated feasibility of embedding an early childhood obesity prevention (ECHO) program in an existing home visitation program (HVP+) during an infant's first year of life.
Five obesity-associated behaviors (i.e., breastfeeding, introduction to solids, limiting juice, sleep routines, screen time) were emphasized through brief interactive lessons utilizing behavior change strategies and an ecological approach by providing linkages to community resources that support healthy behaviors. The pilot program was well received by families, mothers breastfed longer, infants had fewer nocturnal awakenings, were less likely to receive juice, and had a lower weight-for-length (WFL) z-score at 12 months. However, there is a critical need for alternative and innovative, consistent, and sustainable digital delivery methods especially during times when face-to-face home visits are not feasible. Qualitative interviews were conducted with home visitors (n=27) from Florida's (FL) Maternal, Infant Early Childhood Home Visitation (MIECHV) Program and revealed that they were highly receptive to using digital learning with at-risk families.
The specific aims of the proposed research are to a) Develop, refine, and conduct usability testing of early childhood obesity prevention digital learning modules with mothers participating in FL MIECHV; and b) Conduct a pilot RCT of a 12 month digitally-enhanced early childhood obesity prevention intervention (HVP+E), with 50 mother-infant pairs (25 HVP+E/25 standard HVP) participating in FL MIECHV to determine feasibility and acceptability of the HVP+E intervention and study recruitment, implementation and evaluation protocols; and obtain data on preliminary efficacy of the intervention on children's WFL z-scores (primary outcome), maternal feeding practices, child sleep and screen time (secondary outcomes).
Mother-infant dyads (n=50) enrolled in the Maternal, Infant Early Childhood Home Visitation (MIECHV) Program parentally or within one month of giving birth will be randomized to receive either the standard home visitation program (HVP) or the digitally delivered obesity prevention-enhanced home visitation program (HVP+E) for 1 year. HVP+E content will also be expanded to support mothers in engaging fathers and other family members in target behaviors. Mother-infant dyads will be assessed at study entry and at 4, 6 and 12 months. If efficacious, the intervention has potential for public health impact through early childhood obesity prevention in an underserved population, and dissemination through home visitation programs nationwide.
Interventions
- Behavioral digital intervention + home visiting curriculum
Digitally delivered childhood obesity prevention intervention for parents called THRIVES (Teaching Healthy Routines in Very Early Stages) will be provided to complement the standard home visiting curriculum. Parents will complete digital content containing videos, text and checkpoint questions with goal setting during the first year of their child's life over a 12 month period. Assessments will be collected at baseline, 4, 6 and 12 months. - Behavioral Home visiting curriculum
Parents will receive a standard home visiting curriculum delivered in person for at least 1 year during the project timeframe and complete assessments at baseline, 4, 6 and 12 months.
Primary outcome measures
- Child Weight for Length [Time frame: 0, 4, 6, 12 months]
Secondary outcome measures (9)
- Structure and Control in Parent Feeding Questionnaire (SCFQ) [Time frame: 0, 4, 6, 12 months]
- Baby's Basic Needs Questionnaire (BBNQ) [Time frame: 0, 4, 6, and 12 months]
- Feeding behaviors of parents (breastfeeding, timing of juice and solid food introduction) [Time frame: 0, 4, 6 and 12 months]
- Parental obesity prevention knowledge, attitudes, and behaviors [Time frame: From date of randomization until date of completion of the digital modules, assessed up to 1 year.]
- Dietary Screener Questionnaire [Time frame: 0, 4, 6 and 12 months]
- Activity and Screen time [Time frame: 0, 4, 6 and 12 months]
- Brief Infant Sleep Questionnaire [Time frame: 0, 4, 6 and 12 months]
- Family Social Support Questionnaire [Time frame: 0, 4, 6 and 12 months]
- Perceived Stress Scale [Time frame: 0, 4, 6 and 12 months]
Eligibility criteria
Inclusion criteria
- Enrolled in or eligible for home visiting program
- Ages 16 years or older
- Speaks and reads English
- Has no chronic health condition affecting growth or development
- Has a singleton birth > 37 weeks gestation.
Exclusion criteria
- Child has a major malformation
- Child admitted to the NICU
- Child considered small for gestation age (SGA) and/or have a low birth weight (<2500 gms)
- Mother has a significant maternal morbidity (e.g. cancer) or hospitalization for psychiatric disorder in past 6 months
- Extended hospital stay for mom or infant > 5 days
- Unable to speak and read English.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Florida — Gainesville
Identifiers
NCT: NCT07230808 · IRB202501112 · R34HL163373