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New treatment option for Childhood Obesity
Official title Reducing Obesity Through Play Among Toddlers: Tiny Steps to Health (TSHS) Study
ClinicalTrials.gov ID: NCT06918821
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 36. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- include:
- Parents or toddlers who have mental or physical conditions that would prevent engagement in nutrition, physical activity, play, or instructional...
- Parents who are not fluent in English will be excluded because this study was developed, and pilot tested on an English-speaking population. All...
- Parents who are not willing or able to participate in parent-toddler interaction assessments via Zoom will be excluded. This assessment is an...
- Parents who are not willing to be recorded will be excluded because all Families Understanding Nutrition and Physically Active LIfestyles (FUNPALs)...
- 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...
See the full eligibility 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.
- 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...
- 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...
- 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...
- 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)...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 months to 36 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.