Helping toddlers develop healthy eating and activity habits through play
Reducing Obesity Through Play: A Randomized Control Trial
This study is testing different ways to help toddlers eat healthier and be more active through play and parent education.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Months to 36 Months |
| Sex | All |
| Sponsor | University of Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06918821 on ClinicalTrials.gov |
What this trial studies
This study aims to explore different methods for encouraging healthy eating and physical activity behaviors in toddlers. Parents and their toddlers will be randomly assigned to one of three groups: a usual lifestyle group, a health promotion playgroup, or a parent education class. Over a 10-week period, various measures will be collected, including physical assessments of the toddlers and parent-reported surveys on diet, parenting, and child temperament. The study will also observe parent-toddler interactions during play tasks via Zoom to assess engagement and behavior changes.
Who should consider this trial
Good fit: Ideal candidates include parents who are the primary custodians of toddlers aged 18 to 36 months and have regular internet access.
Not a fit: Families with mental or physical conditions that hinder participation in group activities or those who cannot commit to the full program may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to effective strategies for preventing childhood obesity by promoting healthier lifestyles among toddlers.
How similar studies have performed: Other studies have shown success in using play-based interventions to promote healthy behaviors in young children, indicating that this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Parents: Primary custodian (i.e., legal guardian) of a toddler, \>18 years, have regular and frequent access to internet, fluent in English. * Toddlers: \>/=18 and \</=36 months of age, and walking. Exclusion criteria include: * Parents or toddlers who have mental or physical conditions that would prevent engagement in nutrition, physical activity, play, or instructional activities in a group setting or families unwilling to commit to the whole program (e.g., planning to move) will be excluded because participants may be randomly assigned to group interventions where engagement in these activities will be expected. * Parents who are not fluent in English will be excluded because this study was developed, and pilot tested on an English-speaking population. All study materials are in English, the interventions will be offered in English, and most of the surveys are not available or have been validated for non-English speaking audiences. * Parents who are not willing or able to participate in parent-toddler interaction assessments via Zoom will be excluded. This assessment is an important study variable. * Parents who are not willing to be recorded will be excluded because all Families Understanding Nutrition and Physically Active LIfestyles (FUNPALs) Playgroup sessions will be recorded for facilitator supervision purposes, and the parent-toddler interaction assessments will be recorded for later coding. * Only one toddler and one parent per family will be eligible, but all children and siblings within a household will be able to attend playgroups or childcare while parents are in Healthy Toddler Parent Group (HTPG) classes. * Parents and toddlers who received 1 or more sessions of the FUNPALs Playgroup or the HTPG. This study will be running 1 cohort per quarter for 4 years, so it is possible that families may drop out and want to re-enroll in a later cohort or enroll when younger siblings are eligible. They will not be eligible. Also, families from the community will be invited to participate in practice sessions of FUNPALs or HTPG to train the facilitators. These families will not be eligible to participate in the study.
Where this trial is running
Houston, Texas
- University of Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Tracey L Ledoux, PhD
- Email: taledoux@central.uh.edu
- Phone: 713-743-1870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.