Digitally Delivered Child Obesity Prevention for Parents in Home Visiting Programs

NCT07230808 | Not Yet Recruiting

• 2 other identifiers: IRB202501112R34HL163373
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Childhood Obesity Prevention

Keywords

childhood obesity; home visiting; parents; infants; nutrition education; eHealth; digital intervention

Outcome Measures

Primary Outcomes (1)

• Child Weight for Length

  Weight for Length (WFL) z-score. A z-score of 0 indicates a child is a the median for WFL. Scores above 0 indicate that a child has a higher WFL and may be at risk for overweight or obesity. Scores below 0 indicate that a child has a lower WFL and may be at risk for undernutrition.

  0, 4, 6, 12 months

Secondary Outcomes (10)

• Structure and Control in Parent Feeding Questionnaire (SCFQ)

  0, 4, 6, 12 months

• Baby's Basic Needs Questionnaire (BBNQ)

  0, 4, 6, and 12 months

• Feeding behaviors of parents (breastfeeding, timing of juice and solid food introduction)

  0, 4, 6 and 12 months

• Parental obesity prevention knowledge, attitudes, and behaviors

  From date of randomization until date of completion of the digital modules, assessed up to 1 year.

• Dietary Screener Questionnaire

  0, 4, 6 and 12 months

Study Arms (2)

Digital intervention

EXPERIMENTAL

digitally delivered childhood obesity prevention intervention for parents

Behavioral: digital intervention + home visiting curriculum

standard home visiting curriculum

ACTIVE COMPARATOR

standard home visiting program for parents

Behavioral: Home visiting curriculum

Interventions

digital intervention + home visiting curriculum BEHAVIORAL

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.

Digital intervention

Home visiting curriculum BEHAVIORAL

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.

standard home visiting curriculum

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amy Mobley, PhD, RD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Mobley, PhD, RD

CONTACT

352-294-1813; amy.mobley@ufl.edu

Alyssa Watkins, MPH

CONTACT

alyssaberger94@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share