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

Not Applicable

Recruiting

• Conditions: Childhood Obesity

• Registration Number: NCT06918821
• Lead Sponsor: University of Houston

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.

Study Timeline

• Study First Submitted: 2025-03-19
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Study Start: 2025-05-17
• Primary Completion: 2029-02-28
• Study Completion: 2029-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Weight Status	baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)	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.

Secondary Outcome Measures

Name	Time	Method
Toddler Dietary Intake.	baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)	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.
Toddler carotenoid (FV) intake.	baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)	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.
Activity	baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)	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.

Trial Locations

Locations (1)

University of Houston; 🇺🇸 Houston, Texas, United States