Nutrition Education Program for Childhood Obesity

Overseen By Mamie White, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must not be taking: Weight medications

Disqualifiers: Children with disabilities, others

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

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effectiveness and practicality of integrating nutrition education and feeding practices to manage childhood obesity. It involves two groups: one following the usual nutrition curriculum and another trying an enhanced version called the Revised ESBA, which includes new feeding practices. The study seeks parents living in Harris or Fort Bend counties with children aged 4-8 who can access the internet with a device. As an unphased trial, it offers participants a unique opportunity to contribute to innovative strategies in childhood nutrition and obesity management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes parents of children on prescription medications that affect weight or appetite.

What prior data suggests that this nutrition education program is safe for children?

Research has shown that the Revised ESBA program is generally easy for people to follow. Studies have found that it leads to better feeding habits in parents, improving children's diets and making mealtimes more enjoyable. The program also helps families stretch their food budgets. Importantly, no reports of negative effects have emerged from the program. Based on the evidence, the Revised ESBA appears safe for participants, focusing on improving nutrition without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nutrition Education Program for Childhood Obesity because it goes beyond traditional approaches like diet plans or exercise regimes. This program introduces a new curriculum, ESBA + Feeding Practices, which not only focuses on nutrition but also incorporates specific feeding practices. The innovative aspect here is the integration of feeding behavior education, aiming to change how children interact with food on a daily basis, potentially leading to more sustainable, long-term results in managing obesity. Unlike standard programs, this approach could empower children and families with practical skills that directly impact their eating habits.

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

Studies have shown that the Revised ESBA program effectively improves children's nutrition. In this trial, participants in the "ESBA + Feeding Practices" arm will receive the Revised ESBA program combined with information for parents on feeding. Research indicates that this combination leads to better fruit and vegetable intake and overall nutrition. Parents have reported positive changes, such as healthier diets for their children and easier mealtimes. Additionally, the program has helped families stretch their food budget. These findings suggest that the Revised ESBA can significantly help prevent childhood obesity. Meanwhile, the "Usual Practice - ESBA" arm will continue with the existing ESBA curriculum as their usual practice. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for parents living in Harris or Fort Bend counties with a child aged 4-8. Participants must be able to communicate in English or Spanish, have telephone access, and be able to use the internet via a smart device or computer.

Inclusion Criteria

Living in Harris or Fort Bend counties

I am a parent of a child aged between 4 and 8 years.

Having access to the Internet with a smart phone, a tablet, a laptop, or a desktop computer

Exclusion Criteria

Parents who are not able to complete self-report questionnaires

I am a parent of a child with disabilities and/or on medications affecting weight/appetite.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the ESBA-FFYF feeding curriculum in classes using standardized implementation protocols

3 months

Follow-up

Participants are monitored for changes in feeding practices using the Food Parenting Inventory

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Revised ESBA

Trial Overview The study is testing 'Revised ESBA', which integrates Food Rx (prescriptions for healthy foods) with Best Feeding Practices within the EFNEP program to improve children's eating habits and prevent obesity.

How Is the Trial Designed?

Group I: ESBA + Feeding Practices Experimental Treatment 1 Intervention

The intervention site staff will implement the ESBA-FFYF feeding curriculum in classes using standardized implementation protocols.

Group II: Usual Practice - ESBA Active Control 1 Intervention

The control group sites will receive the existing ESBA curriculum which is their usual practice.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Prairie View A&M University

Collaborator

Trials

1

Recruited

30+

Prairie View A&M University

Collaborator

Trials

1

Recruited

30+

University of Houston

Collaborator

Trials

155

Recruited

48,600+

Published Research Related to This Trial

The Expanded Food and Nutrition Education Program (EFNEP) curriculum, Eating Smart-Being Active (ESBA), significantly improved nutrition-related behaviors in adults, including food resource management, food safety, nutrition knowledge, and physical activity levels, with positive changes observed across multiple states.

ESBA outperformed previous curricula in promoting better outcomes for fruit and vegetable intake and overall nutrition, demonstrating its effectiveness and suitability for community nutrition programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome effectiveness of the widely adopted EFNEP curriculum Eating Smart-Being Active. Auld, G., Baker, S., Conway, L., et al.[2014]

A review of eight randomized controlled trials found that family-based nutrition interventions can effectively improve dietary behaviors in children aged 5-18, highlighting the importance of setting family goals and modifying the home food environment.

Successful interventions often included hands-on teaching methods, such as games and group activities, as well as providing incentives like fruit and vegetable vouchers, although concerns about study quality, such as blinding and instrument reliability, were noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based nutrition interventions for obesity prevention among school-aged children: a systematic review. Perdew, M., Liu, S., Naylor, PJ.[2021]

A systematic review of 116 articles found that dietary interventions generally lead to significant short-term weight loss in children and adolescents who are overweight or obese, but many studies lacked rigorous design and follow-up.

There is a critical need for high-quality research to determine the best dietary strategies for managing pediatric obesity, with a focus on long-term sustainability and detailed reporting of dietary interventions and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of interventions in the management of overweight and obese children which include a dietary component. Collins, CE., Warren, JM., Neve, M., et al.[2011]

The Expanded Food and Nutrition Education Program (EFNEP) was successfully integrated into five medical clinics, with physicians generating 686 referrals and 106 parents participating in the 8-week pediatric obesity prevention intervention.

Parents reported significant improvements in their children's behaviors related to sleep, screen time, physical activity, and nutrition, indicating that the intervention was both feasible and beneficial for families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Colocating a Nutrition Education Program into a Medical Clinic Setting to Facilitate Pediatric Obesity Prevention. Shilts, MK., Diaz Rios, LK., Panarella, KH., et al.[2021]

Culinary education interventions for children from low-income families are mostly school-based and focus on teaching children cooking skills, which can help improve nutrition and potentially reduce obesity rates.

Only a small number of studies (9 out of 370) met the criteria for inclusion, indicating a need for more comprehensive research and development in culinary education programs, particularly in involving parents and training program leaders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Culinary Education Programs for Children in Low-Income Households: A Scoping Review. Li, PP., Mackey, G., Callender, C., et al.[2020]

In a 10-week school-based program involving 63 obese children aged 5 to 12, 95% of participants lost weight, achieving an average weight loss of 4.4 kg and a 15.4% decrease in their percentage overweight.

The program was significantly more effective than no intervention, as only 21% of a control group of obese children lost weight, highlighting the importance of comprehensive behavior modification and support in managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A school-based behavior modification, nutrition education, and physical activity program for obese children. Brownell, KD., Kaye, FS.[2018]

The study evaluated different strategies to improve feeding practices in early care and education, finding that the combination of de-implementation and enhanced support (D + E) led to significantly more positive interactions and role modeling during nutrition lessons compared to other strategies.

The D + E group also showed a reduction in negative comments and an increase in positive comments during meals, indicating that these strategies can effectively promote healthier feeding environments despite challenges like interruptions from COVID.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

De-Implementation of Detrimental Feeding Practices in Childcare: Mixed Methods Evaluation of Community Partner Selected Strategies. Swindle, T., Rutledge, JM., Zhang, D., et al.[2022]

The Nutrition Mission, a 14-week health promotion program led by medical students, significantly increased nutrition and exercise knowledge among 35 fifth-grade students in Houston, with scores rising from 68.1% to 78.1% (P<0.001).

The intervention demonstrated feasibility in a socioeconomically disadvantaged school setting, suggesting that student-led health education can effectively enhance knowledge in nutrition and exercise among elementary students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Mission. Patel, CB., Strommen, JJ., Elliott, AM., et al.[2016]

In a 2-year study involving 65 overweight and obese children, those who received a multi-component family-focused education package showed a significant reduction in BMI SDS compared to those who only received body composition monitoring during the control period.

The intervention group had a greater success rate, with 33% achieving a target reduction in BMI SDS, and they gained 5.7 kg less over the study duration, indicating the effectiveness of the educational approach in managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a multi-disciplinary family-based programme for treating childhood obesity (the Family Project). Coppins, DF., Margetts, BM., Fa, JL., et al.[2015]

Dietary interventions for obese children can lead to relative weight loss, as indicated by meta-analyses of 37 randomized controlled trials, although the specifics of these dietary treatments are often poorly documented.

The overall effectiveness of dietary treatments for childhood obesity remains unclear due to the lack of high-quality studies and the variability in study designs and outcomes, highlighting the need for better research in this critical area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring effectiveness of dietetic interventions in child obesity: a systematic review of randomized trials. Collins, CE., Warren, J., Neve, M., et al.[2018]

An educational intervention for family medicine and pediatric providers led to a significant increase in referrals for overweight children from 6% to 16% and laboratory testing from 14% to 26%.

Despite improvements in referrals and lab tests, there were no changes in discussions about weight status or documentation practices, indicating a need for further strategies to enhance these aspects of pediatric obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Care Provider Knowledge and Practice Patterns Regarding Childhood Obesity. Busch, AM., Hubka, A., Lynch, BA.[2019]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1499404619311017

Pairing Feeding Content With a Nutrition Education ... To develop a childhood obesity prevention program, Food, Feeding and Your Family (FFYF), which encourages eating self-regulation in young children.

2. withpower.com withpower.com/trial/phase-pediatric-obesity-8-2023-6995d?fbclid=IwZXh0bgNhZW0CMTEAAR6d4ZZZPIiQ4hSPMD7b5GtULl9y-18zGB1oPWDi2wTHGMKwrxbeGQLPDQG9BQ_aem_yEW0CIRCAsI-9XpFEtE79A

Nutrition Education Program for Childhood Obesity ESBA outperformed previous curricula in promoting better outcomes for fruit and vegetable intake and overall nutrition, demonstrating its effectiveness and ...

3. liebertpub.com liebertpub.com/doi/10.1089/chi.2022.0030

Short-Term Efficacy of a Childhood Obesity Prevention ... This study examined the short-term efficacy of adding parental feeding content to a widely-used nutrition education curriculum for families in low-resourced ...

4. sciencedirect.com sciencedirect.com/science/article/am/pii/S1499404624000575

Parents report positive changes in parental feeding practices 9-10%). that 1) improved children's diets, 2) made mealtimes easier, and 3) stretched food dollars. Differences between focus groups are noted as applicable.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35708621/

Short-Term Efficacy of a Childhood Obesity Prevention ... This study examined the short-term efficacy of adding parental feeding content to a widely-used nutrition education curriculum for families in low-resourced ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10745722/

Nutrition Interventions for Pediatric Obesity Prevention Abstract. Nutrition interventions to prevent pediatric obesity can help to establish healthy habits to improve current and future health.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4492159/

Anticipatory Guidance for Prevention of Childhood Obesity The prevalence of childhood overweight and obesity in the United States has increased by more than 100% since 1971. Primary care clinicians have a unique ...