Recruiting

Tiny Steps to Health

Sponsor:

University of Houston

Code:

NCT06918821

Conditions

Childhood Obesity

Eligibility Criteria

Sex: All

Age: 1 - 3

Healthy Volunteers: Accepted

Interventions

Healthy Toddler Parent Group (HTPG)

Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup

Study Details

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.

Conditions

Childhood Obesity

Study ID

NCT06918821

Start date

May 17, 2025

Status verified date

Apr, 2026

Completion date

Feb 28, 2029

Anticipated

Primary completion date

Feb 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 3

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Healthy Toddler Parent Group (HTPG)

Parent education class

Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup

Family playgroup

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Tracey L Ledoux, PhD

713-743-1870taledoux@central.uh.edu

Craig Johnston, PhD

713-743-0613cajohn25@central.uh.edu

Locations

University of Houston

Recruiting

Houston, Texas, United States, 77204

Contacts

Tracey Ledoux, PhD

713-743-1870taledoux@central.uh.edu

Craig Johnston, PhD

713-743-0613cajohn25@central.uh.edu

Principal Investigator:

Tracey Ledoux, PhD

More Information

Sponsor

University of Houston

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • toddlers
  • diet
  • physical activity
  • parenting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Houston on 2026-05-05.