An interventional study of Healthy Toddler Parent Group (HTPG) and Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup in Childhood Obesity, sponsored by University of Houston. Recruiting at 1 site in United States. Open to participants aged 18 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University of Houston · Not applicable, Interventional, and Prevention
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.
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.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →University of Houston is the lead sponsor of 102 studies on the registry; 17 are open to participants now.
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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 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-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.
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
Parent education class
Family playgroup
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.
Time frame: 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.
Time frame: baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)
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.
Time frame: 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.
Time frame: 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.
Time frame: baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)
Plan to share: Yes — 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.
Supporting information: Study protocol, Informed consent form, Analytic code
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.
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.
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