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Clinical Trial NCT07346300 for Physical Activities is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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We-Move With Windy: Gross Motor Development for Early Childhood 266 At-Home Child-Friendly Randomized

Recruiting
Clinical Trial NCT07346300 is an interventional study for Physical Activities that is recruiting. It started on 28 July 2025 with plans to enroll 266 participants. Led by Arkansas Children's Hospital Research Institute, it is expected to complete by 1 July 2031. The latest data from ClinicalTrials.gov was last updated on 22 January 2026.
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 unders...Show More
Detailed Description
Children born to mothers with obesity are at elevated risk for obesity and related cardiometabolic conditions beginning early in life. Evidence suggests that these children may engage in lower levels of physical activity, experience delays in gross motor skill development, and encounter additional barriers to movement and active play prior to school entry. Early childhood represents a critical window for establishing...Show More
Official Title

Pediatric Physical Activity: Tailored Intervention for Children Born to Mothers With Obesity

Conditions
Physical Activities
Other Study IDs
  • 260646
NCT ID Number
NCT07346300
Start Date (Actual)
2025-07-28
Last Update Posted
2026-01-22
Completion Date (Estimated)
2031-07-01
Enrollment (Estimated)
266
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Preschool children
Early childhood
Physical activity intervention
Gross motor skills
Motor development
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalWe Move with Windy
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.
We Move with Windy
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 ...Show More
No InterventionControl
Children are encouraged to follow the physical activity recommendations of their physician.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Raman Spectroscopy
The Veggie Meter uses Raman Spectroscopy (RS) technology to measures skin carotenoid levels as a biomarker for colorful FV intake with an optical hand scan. RS reflects intake over the prior 4 weeks and is sensitive to individual differences and experimental changes. Children are asked to use hand sanitizer prior to placing their finger in the RS scanner. Scores range from 0 to 100 with higher scores reflecting greater carotenoid intake.
At baseline (prior to intervention initiation) and at post-intervention (approximately 19-25 weeks after baseline).
Accelerometry
Staff provide accelerometer equipment and instructions to family and gather the equipment at the next scheduled on-site intervention assessment. Participants wear the monitors for up to 8 days, including two weekend days, only removing them during showers/baths and water activities such as swimming in a pool, lake, going to a water park, etc.
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)
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Minimum Age
3 Years
Eligible Sexes
All

Mother-child pair where the mother has

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

  • mothers sharing that a doctor has requested that either mother or child not exercise (e.g., asthma).
Arkansas Children's Hospital Research Institute logoArkansas Children's Hospital Research Institute
Study Responsible Party
Taren Swindle, Principal Investigator, Associate Professor, Arkansas Children's Hospital Research Institute
Study Central Contact
Contact: Taren Swindle, 18702360997, [email protected]
1 Study Locations in 1 Countries

Arkansas

Arkansas Children's Research Institute, Little Rock, Arkansas, 72202, United States
Taren Swindle, Contact, 8702360997, [email protected]
Recruiting