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

Reducing Obesity Through Play: A Randomized Control Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Childhood Obesity
• Intervention / Treatment: Behavioral: Healthy Toddler Parent Group (HTPG); Behavioral: Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tracey L Ledoux, PhD; Phone Number: 713-743-1870; Email: taledoux@central.uh.edu
• Study Contact Backup: Name: Craig Johnston, PhD; Phone Number: 713-743-0613; Email: cajohn25@central.uh.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77204
      • Recruiting
      • University of Houston
      • Contact: Craig Johnston, PhD; Phone Number: 713-743-0613; Email: cajohn25@central.uh.edu
      • Contact: Tracey Ledoux, PhD; Phone Number: 713-743-1870; Email: taledoux@central.uh.edu
      • Principal Investigator: Tracey Ledoux, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Healthy Toddler Parent Group (HTPG); Parent education class
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.	Behavioral: Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup; Family playgroup

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Status	Weight-for-length (WFL) percentile for toddlers <24 months. Length and weight measures will each be taken two times and averaged. Trained research assistants will measure height to the nearest 0.1 cm using a recumbent height board for children <24 months. Weight will be measured to the nearest 0.1 kg using an electronic self-calibrating digital scale. For toddlers <24 months, weight for length (WFL) will be calculated. Sex- and age-standardized WFL will be determined from Centers for Disease Control and Prevention (CDC) growth charts. Age and gender corrected WFL will be used to categorize weight status groups: <5th percentile WFL will be considered underweight, 5th-84.99th percentile will be considered normal weight, >85 percentile will be considered overweight and >95 percentile will be considered obese per CDC guidelines.	baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)
Weight Status	Body mass index (BMI) percentile for toddlers >/= 24 months. Height and weight measures will each be taken two times and averaged. Trained research assistants will measure height to the nearest 0.1 cm using a portable stadiometer for children >/=24 months. Weight will be measured to the nearest 0.1 kg using an electronic self-calibrating digital scale. For toddlers >/=24 months, BMI will be calculated. Sex- and age-standardized BMI percentiles will be determined from Centers for Disease Control and Prevention (CDC) growth charts. Age and gender corrected BMI percentile ranks will be used to categorize weight status groups: <5th percentile BMI will be considered underweight, 5th-84.99th percentile will be considered normal weight, >85 percentile will be considered overweight and >95 percentile will be considered obese per CDC guidelines.	baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toddler Dietary Intake.	National Cancer Institute's (NCI's) Automated Self-Administered 24 hour dietary recall (ASA24)- Parents will be sent a link on 3 non-consecutive days via email and/or text within a 1-week period of time. The link will take them to a series of questions to assess what their child has eaten and drank in the last 24-hours. The ASA24 system provides a complete nutritional analysis of the diet including servings of food groups and amounts of micro and macronutrients consumed. The average number of servings of fruits, vegetables, and whole grain foods; grams of sugar; and grams of saturated fat will be retained for this study.	baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)
Toddler carotenoid (FV) intake.	Child fruit and vegetable (FV) consumption will be assessed using dermal reflectance spectrometry (Veggie Meter, Longevity Link Corp). Carotenoids are red, orange, and yellow fat-soluble pigments found in FV, and non-invasively measured dermal carotenoids are a valid and reliable proxy for intake of red, orange, yellow and dark green FV in adults and children. Per standard protocol under the direction of Nancy Moran, PhD (co-investigator) one finger from each child will be scanned using the Veggie Meter (Longevity Link Corp) to provide a linear score that represents dermal carotenoid intensity (0-850). Skin carotenoid levels can range from 0-850 with 3.9% standard deviation (SD). Two readings will be collected and if there is more than 33 units (1 SD based on normative data from manufacturer) difference, a third will be collected.	baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)
Activity	Accelerometers (GT3X+ Actigraph, Pensacola, FL). Following standard protocols for young children41,84,111,112, toddlers will wear the activity monitors for 8-consecutive days with the goal of obtaining at least 4 days of valid wear time. We had increased compliance with wear time by providing CareAline wraps to the families in our pilot study. These wraps are stretchy Velcro-fastened covers that are usually used to protect central line ports from toddlers' curious hands. Research staff will show parents directly how to place the actigraph on their child. Parents will receive an instruction guide to take home for reference and they will be encouraged to call research staff if they have any questions about it at home. Parents will be instructed to keep a detailed log of the child's activity when the child wears the actigraph to differential low count data (sleep vs non wear vs sedentary). Parents will be instructed to return the actigraph during the next measurement session.	baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)

Collaborators and Investigators

• Sponsor: University of Houston
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Baylor College of Medicine; National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2025
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: physical activity; parenting; diet; toddlers
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Pediatric Obesity; Motor Activity
• Other Study ID Numbers: 4899; R01HD114793-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data to be collected include toddler's anthropometric data, skin carotenoid levels, diet (parent report food frequency questionnaire), activity measured via wearable device, demographic qualities (parent report), food insecurity (parent report), and toddler temperament (parent report); parent's behaviors (self-report and observation) and perceptions of interventions (self-report). Data will be collected on parent-toddler dyads at three time points. To facilitate the interpretation and reuse of the data, a README file and data dictionary will be generated and deposited into a repository along with all shared datasets. The README file will include a description of data collection methods. The data dictionary will define and describe all variables in the dataset.
• IPD Sharing Time Frame: Data will be available as soon as possible but no later than within one year of the completion of the funded project period or upon acceptance of specific data for publication. Data will be available a minimum of 10 years after the completion of the funded project.
• IPD Sharing Access Criteria: Deidentified data will be made available as public use data to the research community via openIPSR. Users of the public use data must register with ICPSR and agree to the Terms of Use, which are designed to protect study participants by limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, and requiring immediate reporting of any disclosure of study participant identity. Data users also agree not to share or redistribute any data downloads.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No