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

Part of paid clinical trials in Houston, Texas.

Sponsor
University of Houston
Study ID
NCT06918821
Status
Recruiting
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Conditions

  • Childhood Obesity

Eligibility Criteria

Sex
ALL
Age
18 Months - 36 Months
Healthy Volunteers
Accepted

Interventions

  • Healthy Toddler Parent Group (HTPG) — BEHAVIORAL
    Parent education class
  • Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup — BEHAVIORAL
    Family playgroup

Study Details

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.

Key Dates

Start date
May 17, 2025
Status verified
Apr 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Healthy Toddler Parent Group (HTPG)
    Parents assigned to HTPG will receive 10 weekly classes (60-minutes), which will include instruction on nutrition and physical activity for toddlers from a health educator with group discussion.
  • No Intervention: Usual Lifestyle
    Parent-toddler dyads assigned to the no treatment group will continue their normal day to day routine for 10-weeks. After parents and toddlers have participated in all data collection timepoints, they will receive a 1-month membership to a health club.
  • Experimental: Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup
    Parent-toddler dyads assigned to this group will have access to 10-weekly playgroup sessions (90-minutes each). During sessions, parents and their toddler (and siblings) will be led by 2 facilitators through physical activities, healthy snack time (includes preparation), child-directed playtime, singing, parent coaching, and yoga stretches.

Primary Outcome Measure

Weight Status [ Time Frame: baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of HoustonHoustonTexas77204
Tracey Ledoux, PhD
[email protected]
713-743-1870
Craig Johnston, PhD
[email protected]
713-743-0613
Tracey Ledoux, PhD (PRINCIPAL_INVESTIGATOR)

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