Clinical trial NCT06918821: Reducing Obesity Through Play Among Toddlers: Tiny Steps to Health (TSHS) Study
Official title: Reducing Obesity Through Play: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Obesity
Keywords: toddlers
diet
physical activity
parenting
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Baylor College of Medicine
First posted: 2025-04-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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 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.

Eligibility 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, 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.

Primary outcomes:
measure: Weight Status
timeFrame: baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)
measure: Weight Status
timeFrame: baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)
Secondary outcomes:
measure: Toddler Dietary Intake.
timeFrame: baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)
measure: Toddler carotenoid (FV) intake.
timeFrame: baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)
measure: Activity
timeFrame: baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
References: