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

768 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment 'Nutrition Education for Childhood Obesity'?

Research suggests that responsive feeding, a key component of the treatment, can positively influence parent feeding styles and promote healthier eating behaviors in children, which may help prevent obesity. Studies indicate that interventions focusing on how parents feed their children, rather than just what they feed them, can lead to healthier mealtime interactions and potentially reduce nonresponsive feeding practices. ^{1 2 3 4 5}

Is the Nutrition Education for Childhood Obesity treatment safe for children?

The available research on responsive feeding interventions, which are part of the Nutrition Education for Childhood Obesity treatment, suggests that these programs are generally safe for children. They focus on promoting healthy eating behaviors and improving parent-child feeding interactions without reported safety concerns. ^{2 3 6 7 8}

How does the treatment 'Nutrition Education for Childhood Obesity' differ from other treatments for childhood obesity?

This treatment is unique because it focuses on responsive feeding, which emphasizes the interaction between parents and children during feeding times. It aims to teach parents how to recognize and respond to their child's hunger and fullness cues, promoting healthy eating habits from an early age. Unlike other treatments that may focus solely on diet or exercise, this approach integrates parent education and child self-regulation to prevent obesity. ^{2 3 6 7 8}

What is the purpose of this trial?

This proposal uses an innovative methodological framework, the multiphase optimization strategy (MOST), to design an effective and efficient responsive feeding (RF) intervention that promotes child appetite self-regulation among a high-risk sample: families with preschoolers living in rural poverty. The principles of MOST emphasize efficiency, allowing identification of the most efficacious intervention components (i.e., components that contribute to treatment effects) while minimizing participant burden and cost. ONE PATH will intervene on \~768 dyads recruited from 56 classrooms serving largely low-income, rural populations.

Research Team

Jennifer S Williams, PhD

Principal Investigator

Penn State University

Eligibility Criteria

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

Children must be enrolled in a participating Head Start center

I (or my child) can speak English.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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, 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]

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]

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]

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]

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]

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]

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]

References

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

How pediatricians can improve diet and activity for overweight preschoolers: a qualitative study of parental attitudes. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Responsive Feeding: Strategies to Promote Healthy Mealtime Interactions. [2019]

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

RAISE (Raising Infants to Be Smart Eaters) Pilot Study. [2023]

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

Treatment of pediatric obesity. [2007]

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

Responsive feeding is embedded in a theoretical framework of responsive parenting. [2023]

6. Peru pubmed.ncbi.nlm.nih.gov

[How to feed children? Healthy eating behaviors starting at childhood]. [2021]

7. England pubmed.ncbi.nlm.nih.gov

INSIGHT responsive parenting intervention and infant feeding practices: randomized clinical trial. [2019]

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

Responsive feeding: implications for policy and program implementation. [2023]