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L'essai clinique NCT06918821 (TSHS) pour Obésité de l'enfance est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Université de HoustonReducing Obesity Through Play Among Toddlers: Tiny Steps to Health (TSHS) Study
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L'étude clinique NCT06918821 (TSHS) est un essai interventionnel pour Obésité de l'enfance. Son statut actuel est : en recrutement. L'étude a débuté le 17 mai 2025 et vise à recruter 300 participants. Dirigé par l'Université de Houston, l'essai devrait être terminé d'ici le 28 février 2029. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 9 avril 2025.
Résumé succinct
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.
Description détaillée
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.
Titre officiel
Reducing Obesity Through Play: A Randomized Control Trial
Conditions
Obésité de l'enfanceAutres identifiants de l'essai
Numéro NCT
Date de début (réel)
2025-05-17
Dernière mise à jour publiée
2025-04-09
Date de fin (estimée)
2029-02-28
Inscription (estimée)
300
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
toddlers
diet
physical activity
parenting
diet
physical activity
parenting
Objectif principal
Prévention
Plan d'attribution
Randomisé
Modèle d'intervention
Factoriel
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Comparateur actifHealthy 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. | Healthy Toddler Parent Group (HTPG) Parent education class |
Aucune interventionUsual 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. | N/A |
ExpérimentalFamilies 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. | Families Understanding Nutrition and Physically Active Lifestyles (FUNPALS) Playgroup Family playgroup |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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) |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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) |
Critères d'éligibilité
Âges éligibles
Enfant
Âge minimum
18 Months
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
- 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.
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.
Université de Houston289 essais cliniques actifs à explorer- National Institutes of Health (NIH)
- Baylor College of Medicine291 essais cliniques actifs à explorer
Partie responsable de l'essai
Tracey Ledoux, Investigateur principal, Associate Professor, University of Houston
Contact central de l'essai
Contact: Tracey L Ledoux, PhD, 713-743-1870, [email protected]
Contact: Craig Johnston, PhD, 713-743-0613, [email protected]
1 Centres de l'essai dans 1 pays
Texas
University of Houston, Houston, Texas, 77204, United States
Tracey Ledoux, PhD, Contact, 713-743-1870, [email protected]
Craig Johnston, PhD, Contact, 713-743-0613, [email protected]
Tracey Ledoux, PhD, Investigateur principal
En recrutement