NCT07346300

Brief Summary

The long-term goal of this project is to learn whether a tailored physical activity program is practical, enjoyable, and helpful for families, and whether it has the potential to improve children's physical development and health. Before launching a large study, the research team completed several early phases to make sure the program met families' needs. First, a needs assessment was conducted with mothers to understand barriers to physical activity and what types of support would be most useful. Using this feedback, the program was refined and tested with three mother-child pairs over six weeks. Finally, there was an 18-week pilot randomized trial to examine feasibility and acceptability. Researchers are now conducting a larger randomized trial with up to 266 families. Half of the families are randomly assigned to receive the physical activity program, and half to a comparison group. The program combines fun, age-appropriate movement activities for children with practical support for parents. Sessions focus on building core movement skills such as jumping, balancing, running, and throwing, while also encouraging confidence, coordination, and enjoyment of being active. Activities can be adapted to each child's ability and home environment, making the program realistic for busy families. The program includes both in-person sessions and technology-based activities. In-person sessions provide hands-on support for learning new skills. Technology-based activities offer simple ideas families can use at home or during daily routines, such as hopping games, balance challenges, or quick movement breaks. Because parents in earlier phases wanted nutrition support, in-person sessions also includes a brief, child-friendly exposure to fruits and vegetables, along with simple recipes. A "Tasting Party" at the start of the program allows children to try different foods, and Veggie Meter scans at the beginning and end of the study help track changes in fruit and vegetable intake. Overall, this study will help determine whether a family-tailored physical activity program is a promising approach to improving physical activity, movement skills, and early health indicators in young children born to mothers with obesity.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for not_applicable

Timeline
63mo left

Started Jul 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Jul 2025Jul 2031

Study Start

First participant enrolled

July 28, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

4.9 years

First QC Date

December 4, 2025

Last Update Submit

January 21, 2026

Conditions

Keywords

Preschool childrenEarly childhoodPhysical activity interventionGross motor skillsMotor development

Outcome Measures

Primary Outcomes (1)

  • Test of Gross Motor Development-2

    The Test of Gross Motor Development-2 (TGMD-2)31 was used to assess children's motor skill competence. The TGMD-2 assesses 12 skills: run, gallop, hop, leap, horizontal jump, slide (locomotor skills); striking a stationary ball, stationary dribble, kick, catch, overhand throw, and underhand roll (object control skills). A research team member demonstrates the proficient technique to the child; then, the child is asked to perform the skill twice. Researchers score each attempt to perform the skill based on set criteria. Scores on the TGMD range from 0 to 100 with higher scores reflecting greater gross motor skill proficiency.

    At baseline (prior to intervention initiation) and at post-intervention (approximately 19-25 weeks after baseline).

Secondary Outcomes (2)

  • Raman Spectroscopy

    At baseline (prior to intervention initiation) and at post-intervention (approximately 19-25 weeks after baseline).

  • Accelerometry

    One 7-day assessment period during the intervention (approximately weeks 6-12) and one 7-day assessment period at post-intervention (approximately 19-25 weeks)

Study Arms (2)

We Move with Windy

EXPERIMENTAL

Children and their moms attend 18 weeks of intervention. The first 6 weeks are fully in person for 1 hour, twice per week. The next 6 weeks are 1 in person 1 hour session and 1 zoom-based session for. The final 6 weeks are 2 sessions per week via zoom for 30-45 minuets with one in person session every other week to maintain engagement. The third phase includes home-based activity suggestions.

Behavioral: We Move with Windy

Control

NO INTERVENTION

Children are encouraged to follow the physical activity recommendations of their physician.

Interventions

The intervention is an 18-week, family-centered program designed to increase physical activity and gross motor skills in preschool children born to mothers with obesity. Families in the treatment group participate in fun, developmentally appropriate movement activities-such as jumping, balancing, and throwing-through a mix of in-person sessions and technology-delivered activities that can be done at home. Activities are tailored to each child's skill level and each family's environment. Parents learn simple ways to support activity and practice skills in daily routines. Each in-person session also includes a brief fruit-and-vegetable exposure activity and recipe to promote healthy eating habits

We Move with Windy

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index \>30 and
  • The child is between 3 and 5 years of age.

You may not qualify if:

  • mothers sharing that a doctor has requested that either mother or child not exercise (e.g., asthma).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Research Institute

Little Rock, Arkansas, 72202, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Taren Swindle

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Taren Swindle

CONTACT

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

December 4, 2025

First Posted

January 16, 2026

Study Start

July 28, 2025

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2031

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations