Recruiting

Digital Intervention

Sponsor:

University of Florida

Code:

NCT07230808

Conditions

Childhood Obesity Prevention

Eligibility Criteria

Sex: All

Age: 16 - 65

Healthy Volunteers: Accepted

Interventions

digital intervention + home visiting curriculum

Home visiting curriculum

Study Details

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

Study ID

NCT07230808

Start date

May 21, 2026

Status verified date

Jun, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Digital intervention

digitally delivered childhood obesity prevention intervention for parents

active comparator: standard home visiting curriculum

standard home visiting program for parents

Interventions

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.

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 measure

  • Child Weight for Length [ Time Frame: 0, 4, 6, 12 months ]

Central Contacts and Locations

Central contacts

Amy Mobley, PhD, RD

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

Alyssa Watkins, MPH

alyssaberger94@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Amy Mobley

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

Principal Investigator:

Amy Mobley, PhD

More Information

Sponsor

University of Florida

Last update posted

Jul 6, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-07-06.