Status:
RECRUITING
Reducing Obesity Through Play Among Toddlers: Tiny Steps to Health (TSHS) Study
Lead Sponsor:
University of Houston
Collaborating Sponsors:
National Institutes of Health (NIH)
Baylor College of Medicine
Conditions:
Childhood Obesity
Eligibility:
All Genders
18-36 years
Phase:
NA
Brief 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 ei...
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 ...
Eligibility Criteria
Inclusion
- 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, we will invite families from the community participate in practice sessions of FUNPALs or HTPG to train the facilitators. These families will not be eligible to participate in the study.
Exclusion
Key Trial Info
Start Date :
May 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06918821
Start Date
May 17 2025
End Date
February 28 2029
Last Update
April 9 2025
Active Locations (1)
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1
University of Houston
Houston, Texas, United States, 77204