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

Trial Summary

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 data supports the effectiveness of the treatment Families Understanding Nutrition and Physically Active Lifestyles (FUNPALs) Playgroup for childhood obesity?

The FUNPALs Playgroup treatment showed improvements in toddler eating behaviors, with parents noticing positive changes in their children's health habits. Although there was no significant change in physical activity, the program was well-received and feasible, suggesting it may help improve diet in young children. ^{1 2 3 4 5}

Is the FUNPALs Playgroup intervention safe for children?

The FUNPALs Playgroup intervention, which includes physical activities and health education, was well-received by parents and showed improvements in children's eating behaviors, suggesting it is safe for use in young children. ^{1 2 3 5 6}

How is the FUNPALs Playgroup treatment different from other childhood obesity treatments?

The FUNPALs Playgroup treatment is unique because it combines physical and snack activities with health information and positive parenting coaching, specifically targeting toddlers and their parents in a playgroup setting. This approach focuses on improving toddler diet and activity behaviors through interactive sessions, which is different from traditional treatments that may not involve direct parent-child interaction or play-based learning. ^{1 2 3 7 8}

What is the purpose of this 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.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Impact evaluation of "Have Fun - Be Healthy" program: A community based health promotion intervention to prevent childhood obesity. [2019]

2. Switzerland 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. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Play & Grow: prospective observational cohort of toddlers to inform obesity prevention, Columbus, Ohio, USA. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Supported playgroups as a setting for promoting physical activity of young children: findings from a feasibility study in south-west Sydney, Australia. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Energy balance for kids with play: design and implementation of a multi-component school-based obesity prevention program. [2014]

6. England pubmed.ncbi.nlm.nih.gov

Study protocol for Healthy Conversations @ Playgroup: a multi-site cluster randomized controlled trial of an intervention to promote healthy lifestyle behaviours in young children attending community playgroups. [2021]

7. United States 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Obese children playing towards an active lifestyle. [2010]