RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Reducing Obesity Through Play: A Randomized Control Trial

Quick Facts

Study Start:2025-05-17
Study Completion:2029-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06918821

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Months to 36 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Parents: Primary custodian (i.e., legal guardian) of a toddler, \>18 years, have regular and frequent access to internet, fluent in English.
  2. * Toddlers: \>/=18 and \</=36 months of age, and walking.
  3. * 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.
  4. * 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.
  5. * 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.
  6. * 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.
  7. * 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.
  8. * 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.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Tracey L Ledoux, PhD
CONTACT
713-743-1870
taledoux@central.uh.edu
Craig Johnston, PhD
CONTACT
713-743-0613
cajohn25@central.uh.edu

Study Locations (Sites)

University of Houston
Houston, Texas, 77204
United States

Collaborators and Investigators

Sponsor: University of Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-17
Study Completion Date2029-02-28

Study Record Updates

Study Start Date2025-05-17
Study Completion Date2029-02-28

Terms related to this study

Keywords Provided by Researchers

  • toddlers
  • diet
  • physical activity
  • parenting

Additional Relevant MeSH Terms

  • Childhood Obesity