Play-Based Interventions for Childhood Obesity

(TSHS Trial)

Overseen By Craig Johnston, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Houston

Disqualifiers: Mental conditions, Physical conditions, English fluency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 10 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores methods to encourage toddlers to develop healthier eating and activity habits. Families will be randomly assigned to one of three groups: continuing their usual lifestyle, joining a health-focused playgroup (Families Understanding Nutrition and Physically Active Lifestyles, or FUNPALs Playgroup), or participating in educational classes for parents while toddlers are in childcare (Healthy Toddler Parent Group, or HTPG). The trial tracks each toddler's growth, diet, and activity levels, and observes parent-child interactions. Families with toddlers aged 18 to 36 months who are already walking and have internet access may be a good fit for this study. As an unphased trial, this study offers families the chance to contribute to valuable research that could shape healthier futures for children.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on lifestyle and behavior changes rather than medication use.

What prior data suggests that these interventions are safe for toddlers?

Research has shown that the Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup is a safe and well-received program for toddlers. Studies have found that toddlers in FUNPALs sessions did not experience any major negative effects. The program includes enjoyable activities such as physical play, healthy snacks, and yoga stretches, all designed to benefit young children.

The Healthy Toddler Parent Group (HTPG) focuses on teaching parents about toddler nutrition and physical activity. It is considered safe because it involves learning and discussion rather than physical activities with the toddlers.

Both programs aim to encourage healthy habits in toddlers without using direct medical treatments, making them low-risk options for families interested in play-based programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for childhood obesity because they focus on engaging both parents and toddlers in a fun and interactive way. Unlike traditional methods that might focus solely on diet or exercise, the FUNPALs Playgroup combines physical activities, healthy snack preparation, and child-directed playtime, all within a supportive group setting. This holistic approach not only encourages physical activity but also emphasizes the importance of nutrition in a playful and stress-free environment. The Healthy Toddler Parent Group (HTPG) also stands out by offering structured classes that educate parents on nutrition and physical activity, fostering a comprehensive understanding of healthy lifestyles. These programs aim to create lasting lifestyle changes by involving the whole family, which is a fresh and promising strategy in tackling childhood obesity.

What evidence suggests that this trial's treatments could be effective for childhood obesity?

This trial will compare the Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup with the Healthy Toddler Parent Group (HTPG) and a usual lifestyle group. Studies have shown that the FUNPALs Playgroup can help toddlers eat better and be more active. Research indicates that this play-based approach helps parents create healthier home environments, leading to improved eating habits in toddlers. In previous studies, parents noticed positive changes in their children's health habits after participating in these sessions.

For the Healthy Toddler Parent Group (HTPG), research suggests that parent-only group sessions can effectively improve children's weight and health habits. One study found a significant drop in children's BMI z-scores after two years, demonstrating long-term benefits. However, some studies have mixed results, indicating that while behavior changes occur, they may not always lead to noticeable changes in BMI. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

The TSHS study is for parents and toddlers aiming to develop healthy eating and activity habits. Eligible participants are those willing to be randomly assigned to different groups, with one group continuing their current lifestyle before receiving a health club membership, another attending a playgroup focused on health promotion, or joining an educational class for parents while toddlers receive childcare.

Inclusion Criteria

I am the legal guardian of a toddler.

My toddler is between 18 and 36 months old and can walk.

Exclusion Criteria

Parents who are not fluent in English

I am not willing to be recorded.

Parents or toddlers with mental or physical conditions that would prevent engagement in group activities

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to one of three groups for 10 weeks: usual lifestyle, FUNPALs playgroup, or Healthy Toddler Parent Group

10 weeks

Weekly sessions (in-person or virtual)

Immediate Follow-up

Data collection on diet, activity, and other measures immediately after the treatment phase

1 week

1 visit (in-person or virtual)

Long-term Follow-up

Participants are monitored for long-term effects on diet, activity, and other measures

14 weeks

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup
• Healthy Toddler Parent Group (HTPG)

Trial Overview This trial tests three approaches: maintaining usual lifestyle then getting a gym membership; participating in the FUNPALs Playgroup promoting active lifestyles; or enrolling in the HTPG where parents learn about nutrition while toddlers are cared for. The study measures physical stats of toddlers, parent-reported surveys, and observes parent-toddler interactions over Zoom.

How Is the Trial Designed?

Group I: Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup Experimental Treatment 1 Intervention

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.

Group II: Healthy Toddler Parent Group (HTPG) Active Control 1 Intervention

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.

Group III: Usual Lifestyle Active Control 1 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.

Who Is Running the Clinical Trial?

University of Houston

Lead Sponsor

Trials

155

Recruited

48,600+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

The Play & Grow Cohort study includes 300 diverse toddlers and their caregivers, focusing on parent-child interactions during mealtime and play to understand obesity prevention, particularly in children born preterm.

Data collection involved video recordings of interactions at various ages, with plans for future assessments during middle childhood to include more detailed measurements and school-based outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Play & Grow: prospective observational cohort of toddlers to inform obesity prevention, Columbus, Ohio, USA. Parrott, A., Zvara, BJ., Keim, SA., et al.[2022]

A new behavior checklist was successfully developed to measure changes in family eating habits, physical activity, and parenting practices after an intervention aimed at low-income parents of children aged 3 to 11, demonstrating good reliability (r = 0.83).

The checklist was found to be feasible for use in community nutrition programs and showed significant correlations with established measures of dietary habits and physical activity, indicating its effectiveness in evaluating educational interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a measure of behavior change in a program to help low-income parents prevent unhealthful weight gain in children. Dickin, KL., Lent, M., Lu, AH., et al.[2022]

The FUNPALs Playgroup, a 10-week program for parents and toddlers, showed significant improvements in toddler diet, with a large effect size, indicating it effectively enhanced healthy eating behaviors among participants.

While the program was well-received and had high retention rates (78%), it did not show a statistically significant improvement in physical activity levels for toddlers, suggesting that while dietary changes were successful, more focus may be needed on increasing physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Efficacy of the "FUNPALs Playgroup" Intervention to Improve Toddler Dietary and Activity Behaviors: A Pilot Randomized Controlled Trial. Cepni, AB., Taylor, A., Crumbley, C., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8345510/

Feasibility and Efficacy of the “FUNPALs Playgroup ... This study evaluated the feasibility and effects of the Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup on toddler (12–36 ...

2. researchgate.net researchgate.net/publication/353421577_Feasibility_and_Efficacy_of_the_FUNPALs_Playgroup_Intervention_to_Improve_Toddler_Dietary_and_Activity_Behaviors_A_Pilot_Randomized_Controlled_Trial

(PDF) Feasibility and Efficacy of the “FUNPALs Playgroup” ... This study evaluated the feasibility and effects of the Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup on toddler ...

3. withpower.com withpower.com/trial/phase-obesity-4-2025-18c59

Play-Based Interventions for Childhood Obesity (TSHS 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 ...

4. ars.usda.gov ars.usda.gov/research/publications/publication/?seqNo115=372480

Children's Nutrition Research Center: Houston, TX The FUNPALs Playgroup, largely based on Social Cognitive Theory and Family Systems Theory, aimed to improve toddler diet by helping parents to ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34360118/

Feasibility and Efficacy of the "FUNPALs Playgroup ... - PubMed This study evaluated the feasibility and effects of the Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup on toddler (12-36 ...