Nutrition Education for Childhood Obesity

(ONE PATH Trial)

Overseen By Jennifer S Williams, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Disqualifiers: Child not enrolled, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore effective ways to combat childhood obesity in low-income, rural families by helping preschool children learn to regulate their appetites. The researchers will test different combinations of interventions involving children (Child Intervention), parents (Parent Intervention), and early childhood education (ECE) providers to identify the best approach. Families with children aged 2 to 6, enrolled in a participating Head Start or Pre-K Counts program, and who speak English may be a good fit for this trial. As an unphased trial, this study offers families the opportunity to contribute to groundbreaking research that could shape future obesity interventions.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that responsive feeding practices can be safe and beneficial for children. One study found that a responsive parenting program reduced the number of overweight children. Specifically, 11.2% of children in the responsive group were overweight, compared to 19.8% in the non-responsive group. This suggests that responsive feeding can help children maintain a healthier weight.

For parents, these programs have reduced BMI (Body Mass Index) in young children, indicating healthy growth. These programs teach parents to recognize and respond to their children's hunger and fullness signals, which can help prevent obesity.

Overall, these programs appear well-received and have not raised major safety concerns. Responsive feeding helps children eat according to their bodies' needs, supporting healthy development and weight management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for childhood obesity because they focus on holistic, family-centered strategies rather than individual treatment. Unlike standard care options, which often emphasize diet and exercise for the child alone, these interventions involve both children and parents in educational and behavioral changes. The approach includes parent-responsive feeding and regulation techniques, aiming to create healthier eating habits and environments at home. This comprehensive method could lead to more sustainable lifestyle changes, potentially offering more effective results in managing childhood obesity.

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

Research has shown that responsive feeding, where parents adjust feeding based on their child's hunger and fullness signals, can help manage childhood obesity. In this trial, some participants will join parent-focused programs, such as the Parent Intervention, which studies have found can lead to healthier weight patterns in children. For example, one study reported a noticeable drop in children's weight when they participated in a responsive parenting program. Other participants will join child-focused programs, like the Child Intervention, which have also proven effective, showing better weight outcomes than usual care. Overall, both parent-focused and child-focused programs in this trial offer useful ways to support healthier weight management in children. ^{1 3 4 6 7}

Who Is on the Research Team?

Jennifer S Williams, PhD

Principal Investigator

Penn State University

Are You a Good Fit for This Trial?

This trial is for families with preschoolers aged 2-6 years, living in rural poverty and enrolled in a participating Head Start center. The parent or caregiver must be over 18 and speak English. Early Childhood Education (ECE) providers are eligible if they work at the participating centers.

Inclusion Criteria

I (or my child) can speak English.

Children must be enrolled in a participating Head Start center

ECE providers must be employed in participating Head Start center

Exclusion Criteria

Parents will not be eligible to participate if their child is not eligible and/or not enrolled in the study

ECE providers will not be eligible if they do not teach in a participating preschool classroom

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of responsive feeding and appetite regulation interventions for ECE providers, preschool children, and parents over the school year

9 months

Ongoing engagement through online and in-person activities

Follow-up

Participants are monitored for changes in feeding practices, child appetite regulation, and BMI z-scores

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Child intervention
• Child regulation
• CORE NAP SACC
• Early Childhood Education
• ECE Provider
• Parent Intervention
• Parent Responsive Feeding

Trial Overview ONE PATH aims to create an efficient responsive feeding intervention to help children regulate their appetite, potentially reducing childhood obesity. It will test various educational strategies on around 760 families across 64 classrooms using existing nutrition program infrastructure.

How Is the Trial Designed?

Group I: Parent on/Child on Experimental Treatment 2 Interventions

ECE Provider intervention turned off Parent intervention turned on Child intervention turned on

Group II: Parent on Experimental Treatment 1 Intervention

ECE Provider intervention turned off Parent intervention turned on Child intervention turned off

Group III: ECE on/Parent on Experimental Treatment 2 Interventions

ECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned off

Group IV: ECE on/Child on Experimental Treatment 2 Interventions

ECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned on

Group V: ECE on Experimental Treatment 1 Intervention

ECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned off

Group VI: Child on Experimental Treatment 1 Intervention

ECE Provider intervention turned off Parent intervention turned off Child intervention turned on

Group VII: All Factors On Experimental Treatment 3 Interventions

ECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned on

Group VIII: All Factors Off Active Control 1 Intervention

ECE Provider intervention turned off Parent intervention turned off Child intervention turned off

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

Published Research Related to This Trial

The responsive parenting (RP) intervention significantly improved feeding practices among mothers, promoting structured feeding routines and reducing non-responsive practices like using food to soothe infants, which could help lower obesity risk.

Mothers in the RP group were more likely to set limits and maintain consistent feeding schedules, indicating that early guidance on responsive feeding can positively influence infant feeding behaviors in the first year of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

INSIGHT responsive parenting intervention and infant feeding practices: randomized clinical trial. Savage, JS., Hohman, EE., Marini, ME., et al.[2019]

A pilot study involving 27 parents (18 in the intervention group and 9 in the control group) showed that a brief responsive feeding education intervention by public health nurses during well-baby visits is feasible and acceptable, despite challenges in recruitment and retention.

Parents who received the intervention exhibited a trend towards adopting less nonresponsive feeding practices, suggesting that the education may positively influence their attitudes and behaviors related to feeding their infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RAISE (Raising Infants to Be Smart Eaters) Pilot Study. Hale, I., Fergus, T., Buhler, H., et al.[2023]

Responsive parenting, which involves a structured and emotionally supportive interaction between caregivers and children, is crucial for developing healthy eating behaviors in children.

The paper suggests that incorporating responsive feeding practices into strategies aimed at promoting healthy growth can help prevent both underweight and overweight issues in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responsive feeding is embedded in a theoretical framework of responsive parenting. Black, MM., Aboud, FE.[2023]

Parents of overweight preschoolers prefer clear terms like 'overweight' and 'obese' when pediatricians explain the health risks, as long as they provide a rationale for these classifications.

While parents expressed confidence in adopting most recommended behaviors to improve their children's diet and activity, they specifically requested more guidance on increasing vegetable intake and acknowledged barriers to limiting screen time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How pediatricians can improve diet and activity for overweight preschoolers: a qualitative study of parental attitudes. Bolling, C., Crosby, L., Boles, R., et al.[2022]

Responsive feeding has been increasingly recognized and incorporated into nutrition policies and guidelines by international agencies and organizations over the past two decades, highlighting its importance in child nutrition and growth.

Despite a lack of extensive effectiveness trials, there is a push for improving the specificity of responsive feeding interventions and developing tailored protocols and support materials to enhance program implementation in various contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responsive feeding: implications for policy and program implementation. Engle, PL., Pelto, GH.[2023]

Responsive feeding, which focuses on the interactions between parents and children during feeding, is crucial during the complementary feeding stage as children transition to solid foods, yet there are few intervention trials to support its effectiveness.

To improve outcomes in child growth and feeding, more research is needed to clarify measurement and intervention strategies in responsive feeding, emphasizing the importance of healthy mealtime interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responsive Feeding: Strategies to Promote Healthy Mealtime Interactions. Black, MM., Hurley, KM.[2019]

Interventions aimed at preventing malnutrition or overweight in children should focus not only on diet but also on the behaviors of their caretakers, as these behaviors significantly influence children's long-term nutrition patterns.

Adopting a 'responsive' feeding approach, where caretakers guide and respond to children's hunger and fullness cues, can promote self-regulation and awareness of healthy eating in children, making it a crucial component of effective nutritional interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[How to feed children? Healthy eating behaviors starting at childhood]. Black, MM., Creed-Kanashiro, HM.[2021]

Childhood obesity interventions aim to regulate body weight and fat while ensuring proper nutrition for growth, with successful programs leading to healthier eating and exercise behaviors that can persist into adulthood.

While these interventions can lead to positive health outcomes like reduced blood pressure and improved insulin sensitivity, they also carry risks such as the potential development of disordered eating patterns, highlighting the need for careful implementation and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of pediatric obesity. Epstein, LH., Myers, MD., Raynor, HA., et al.[2007]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3040906/

A Systematic Review of Responsive Feeding and Child ... Further, randomized controlled trials are needed to test the efficacy of responsive feeding interventions to treat and to prevent childhood obesity.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8107859/

Effectiveness of dietary interventions on weight outcomes ... The results revealed that children who received dietary interventions had greater reduction in BMI when compared with usual healthcare (WMD: –0.12; 95% CI: – ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522032397

Caregiver feeding practices and child weight outcomes All 4 controlled trials were effective at influencing ≥1 of the weight outcomes assessed (Table 2): 2 of the RCTs were effective at reducing rapid weight gain ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2695671

Effect of a Responsive Parenting Educational Intervention ... A responsive parenting intervention significantly reduced body mass index z scores compared with controls (−0.13 vs 0.15, respectively) at age 3 years.

5. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03817021

ONE PATH: Optimizing Nutrition Education for Parents and ... The investigators will examine whether food security and child temperament explain the effects of the intervention on the outcomes (child appetite regulation, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30088009/

Effect of a Responsive Parenting Educational Intervention on ... Of 116 children in the responsive parenting group, 13 (11.2%) were overweight vs 23 (19.8%) of 116 children in the control group (absolute ...

7. magazine.medlineplus.gov magazine.medlineplus.gov/article/preventing-childhood-obesity-program-for-first-time-parents-promotes-healthy-growth-in-firstborn-babies-and-their-siblings

Preventing childhood obesity: Program for first-time ... One approach to preventing obesity in children is a practice called “responsive feeding,” which includes teaching new parents strategies for ...