Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06918821

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Months to 36 Months
SexAll
Healthy volunteersAccepted
ConditionChildhood Obesity

Full registry 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 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.

Treatments and study arms

Healthy Toddler Parent Group (HTPG)

Behavioral

Parent education class

Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup

Behavioral

Family playgroup

Primary outcomes

Weight Statusbaseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)

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.

Weight Statusbaseline (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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Houston🇺🇸 Houston, Texas, United States
Tracey Ledoux, PhDContact
Craig Johnston, PhDContact
Tracey Ledoux, PhDPrincipal Investigator