Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06918821

Reducing Obesity Through Play Among Toddlers: Tiny Steps to Health (TSHS) Study

Reducing Obesity Through Play: A Randomized Control Trial

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
300 (estimated)
Sponsor
University of Houston · Academic / Other
Sex
All
Age
18 Months – 36 Months
Healthy volunteers
Accepted

Summary

The purpose of this study is to test various ways to help toddlers develop healthy eating and activity behaviors. Parents and toddlers, who participate in this research will be randomly assigned to either 1) continue their lifestyle behaviors for 10-weeks and then receive a health club membership for 1-month, 2) attend a health promotion playgroup together for 10 weeks, or 3) to attend an educational class for parents while toddlers are in childcare for 10-weeks. Physical measures of toddlers (height, weight, dietary intake, activity) will be collected. Parent-report surveys with questions about parenting, toddler diet, toddler temperament, food security status, demographic qualities, and satisfaction with group assignment will be collected. Last, the interactions between parents and toddlers will be observed and assessed during short play tasks via Zoom. All measures will be collected immediately upon signing up for the study (week 0), 10-weeks later (post), and 24-weeks after signing up for the study.

Detailed description

In this randomized control trial, 300 parent-toddler dyads will be recruited and randomly assigned to one of three groups for 10-weeks. Those dyads assigned to the usual lifestyle group will not make any changes and will maintain their normal behaviors. Dyads assigned to the Families Understanding Nutrition and Physically Activity Lifestyles (FUNPALs) Playgroup will be invited to attend weekly playgroup sessions together. For those assigned to the Healthy Toddler Parent Group, parents will attend weekly health education classes where toddler health behaviors will be discussed. At baseline (week 0), immediate follow up (week 10-11), and long term follow up (week 24) parent report, physical, and observational measures of diet, activity, parenting, child temperament, food insecurity status, and quality of life will be completed.

Conditions

Interventions

TypeNameDescription
BEHAVIORALHealthy Toddler Parent Group (HTPG)Parent education class
BEHAVIORALFamilies Understanding Nutrition and Physically Active Lifestyles (FUNPALs) PlaygroupFamily playgroup

Timeline

Start date
2025-05-17
Primary completion
2029-02-28
Completion
2029-02-28
First posted
2025-04-09
Last updated
2025-04-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06918821. Inclusion in this directory is not an endorsement.