Childhood ObesityTSHSNCT06918821
Reducing Obesity Through Play Among Toddlers: Tiny Steps to Health (TSHS) Study
A study testing Healthy Toddler Parent Group (HTPG) and Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup in people with Childhood Obesity, run by University of Houston at 1 site in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Healthy Toddler Parent Group (HTPG) and Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2025to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Houston
Houston, Texas, 77204
Tracey Ledoux, PhD, 713-743-1870, taledoux@central.uh.edu
Craig Johnston, PhD, 713-743-0613, cajohn25@central.uh.edu
About this study
Official title: Reducing Obesity Through Play: A Randomized Control Trial
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.
Read the detailed description
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.
- Conditions
- Childhood Obesity
- Being tested
- Healthy Toddler Parent Group (HTPG), Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup
- Keywords
- toddlers, diet, physical activity, parenting
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Toddler Parent Group (HTPG)Behavioural
Parent education class
Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) PlaygroupBehavioural
Family playgroup
| Study group | Role | What they receive |
|---|---|---|
| Healthy Toddler Parent Group (HTPG) | Active comparator | 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. Receives: Behavioral: Healthy Toddler Parent Group (HTPG) |
| Usual Lifestyle | No intervention | 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. |
| Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup | Experimental | 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. Receives: Behavioral: Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start17 May 2025
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Baylor College of Medicine, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Tracey Ledoux, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918821
- Sponsor's protocol ID
- 4899
- Other IDs
- R01HD114793-01
- Acronym
- TSHS
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Obesity Through Play: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06918821
- Acronym / sponsor ID
- TSHS / 4899
- Conditions
- Childhood Obesity
- Keywords
- toddlers, diet, physical activity, parenting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Baylor College of Medicine, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 17 May 2025 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Toddler Parent Group (HTPG) | Active comparator | Behavioral: Healthy 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. |
| Usual Lifestyle | No intervention | –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. |
| Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup | Experimental | Behavioral: Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) PlaygroupParent-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. |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Toddler Parent Group (HTPG)Parent education class | Behavioural | Healthy Toddler Parent Group (HTPG) |
| Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) PlaygroupFamily playgroup | Behavioural | Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup |
Primary outcome
Weight Status
Time frame: baseline (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 Status
Time frame: baseline (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.
3 secondary outcomes
Toddler Dietary Intake.
Time frame: baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)
Toddler carotenoid (FV) intake.
Time frame: baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)
Activity
Time frame: baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Toddler Parent Group (HTPG) and Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup in people with Childhood Obesity, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tracey L Ledoux, PhD (713-743-1870, taledoux@central.uh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Status (time frame: baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.