跳至主要内容
临床试验/NCT07346300
NCT07346300招募中不适用

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

Arkansas Children's Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2025年7月28日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
266
试验地点
1
主要终点
Test of Gross Motor Development-2

研究概览

简要总结

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.

详细描述

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 movement competence, physical activity behaviors, and dietary exposures that track into later childhood and adulthood. Interventions during this developmental period may therefore offer an important opportunity to reduce health risk trajectories. To address this need, the research team developed a family-based, developmentally tailored physical activity intervention designed to support gross motor skill development, promote enjoyable movement experiences, and reinforce healthy eating behaviors among preschool-aged children at elevated risk.

Prior to initiating the this trial, the team conducted a series of formative and pilot phases to refine intervention components and ensure alignment with family needs and preferences. First, a needs assessment with mothers of preschool-aged children was conducted to identify perceived barriers to child physical activity, contextual constraints within the home environment, and desired forms of support. Findings from this phase informed iterative refinement of program content and delivery strategies. Next, the revised materials were pre-tested with three mother-child dyads over a six-week period to assess usability, engagement, and logistical feasibility. Building on these findings, we conducted an 18-week pilot randomized trial to further evaluate feasibility, acceptability, and preliminary implementation outcomes.

The current study is a larger-scale randomized controlled trial enrolling up to 266 families. Families are randomized to either the intervention condition or a control condition. The intervention integrates developmentally appropriate, play-based movement activities for children with structured support for parents to facilitate and reinforce physical activity in the home. Intervention sessions focus on foundational gross motor skills-including jumping, balancing, running, and throwing-while also fostering coordination, self-efficacy, and positive affect toward physical activity. Activities are designed to be adaptable to children's developmental skill levels and household environments, enhancing feasibility for diverse families.

Intervention delivery combines in-person and technology-delivered components. In-person sessions provide hands-on instruction and guided practice to support skill acquisition and movement confidence. Technology-delivered components extend learning beyond in-person sessions by offering brief, low-burden activity prompts that families can integrate into daily routines (e.g., movement games during transitions, short balance or hopping challenges, or active play during household tasks). This hybrid approach is intended to promote skill generalization, reinforce parent engagement, and support sustained physical activity opportunities in the home.

In response to strong interest expressed by parents during formative work, nutrition exposure is embedded in in-person sessions. Children participate in brief, developmentally appropriate fruit and vegetable tastings, accompanied by simple, family-friendly recipes to encourage at-home practice. Objective assessment of fruit and vegetable intake is conducted at baseline and follow-up using Veggie Meter scans to examine changes in carotenoid status over time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
3 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mother-child pair where the mother has
  • Body mass index >30 and
  • The child is between 3 and 5 years of age.

排除标准

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

研究组 & 干预措施

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.

干预措施: We Move with Windy (Behavioral)

Control

No Intervention

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

结局指标

主要结局

Test of Gross Motor Development-2

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

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.

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Taren Swindle

Associate Professor

Arkansas Children's Hospital Research Institute

研究点 (1)

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