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

NCT ID: NCT06918821

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-17
• Study Completion Date: 2029-02-28

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.

Conditions

Childhood Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Healthy Toddler Parent Group (HTPG)

Intervention Type: BEHAVIORAL

Parent education class

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup

Intervention Type: BEHAVIORAL

Family playgroup

Interventions

Healthy Toddler Parent Group (HTPG)

Parent education class

Intervention Type: BEHAVIORAL

Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup

Family playgroup

Intervention Type: BEHAVIORAL

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

• 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.

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

University of Houston

OTHER

Sponsor Role: lead

Responsible Party

Tracey Ledoux

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Houston

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tracey L Ledoux, PhD

Role: CONTACT

taledoux@central.uh.edu

713-743-1870

Craig Johnston, PhD

Role: CONTACT

cajohn25@central.uh.edu

713-743-0613

Facility Contacts

Tracey Ledoux, PhD

Role: primary

taledoux@central.uh.edu

713-743-1870

Craig Johnston, PhD

Role: backup

cajohn25@central.uh.edu

713-743-0613

Other Identifiers

R01HD114793-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4899

Identifier Type: -

Identifier Source: org_study_id