Nutrition Education for Childhood Obesity

Recruiting at 1 trial location

Overseen By Study Coordinator

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Premature birth, Underweight, Special diets, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 months

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Food FARMacia program can reduce food insecurity for families with young children. Participants will receive groceries twice a month and learn about preparing healthy meals, alongside standard pediatric care. Families with infants aged 6 to under 18 months, who face food insecurity and receive primary care at Stanford, might be a good fit. The study will compare the Food FARMacia program to regular nutrition education to assess its effectiveness. As an unphased trial, it offers families the opportunity to access additional resources and support to improve their nutritional well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It seems focused on nutrition education, so it's unlikely that medication changes are required, but you should confirm with the study team.

What prior data suggests that the Food FARMacia Program and self-directed meal preparation support are safe for families with infants?

Research has shown that the Food FARMacia program is safe and well-tolerated. One study demonstrated that a mobile food pantry linked to children's healthcare helped prevent significant weight gain in kids over six months, indicating positive results with no reported negative effects. Another study found improvements in children's weight, further supporting the program's safety and effectiveness. No reports of harmful side effects have emerged, reassuring families considering participation. Overall, the program's focus on providing healthy food appears safe for participating children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nutrition Education for Childhood Obesity trial because it takes a fresh approach to tackling obesity in kids. Unlike traditional methods that often focus on diet plans or medication, this trial emphasizes practical support through the Food FARMacia program, which provides groceries twice a month. This approach not only addresses nutritional education but also ensures families have access to healthy foods, making it easier to implement healthier eating habits at home. Additionally, the trial includes self-directed meal preparation support, empowering participants to build lifelong skills for managing their nutrition independently.

What evidence suggests that the Food FARMacia intervention is effective for reducing food insecurity in families with young children?

Research has shown that the Food FARMacia program, available to participants in this trial, can help reduce childhood obesity. One study found that providing fresh and healthy foods through a mobile pantry led to smaller increases in children's BMIz—a measure of body weight compared to height—over six months. This program addresses food insecurity, which can contribute to obesity. Another arm of this trial will offer nutrition education and anticipatory guidance to support healthy meal preparation. These findings suggest that improving food access and education can positively impact children's health. ^{1 2 3 4 5}

Who Is on the Research Team?

Jennifer Woo Baidal, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for families with infants aged 6 to less than 18 months who are patients at Columbia/NYP Ambulatory Care Network, have food insecurity as per their health records and confirmed by a screening call. The infant must be born full-term without undernutrition issues and live in a community setting with an enrolled caretaker.

Inclusion Criteria

My child is between 6 and 18 months old.

My household has been documented as having food insecurity for my child under 18 months.

I was born full-term and have not shown signs of undernutrition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Food FARMacia intervention with twice monthly food distributions and self-directed meal preparation support for 6 months

6 months

Twice monthly visits for food distribution

Follow-up

Participants are monitored for feasibility, acceptability, and satisfaction with the intervention, as well as changes in infant weight characteristics and food insecurity

6 months

Follow-up visits at 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Food FARMacia Program
• Self-directed meal preparation support

Trial Overview The Food FARMacia program aims to see if providing nutrition education and support for healthy meal preparation alongside usual care can reduce childhood obesity among families facing food insecurity.

How Is the Trial Designed?

Group I: Food FARMacia intervention Experimental Treatment 2 Interventions

Participants will enroll in the Food FARMacia program and receive groceries twice monthly for 6 months. They will also receive nutrition education and anticipatory guidance to support healthy meal preparation.

Group II: Attention Control Active Control 1 Intervention

Participants will receive nutrition education and anticipatory guidance to support healthy meal preparation in addition to usual care.

Food FARMacia Program is already approved in United States for the following indications:

Approved in United States as Food FARMacia Program for:

• Reducing food insecurity
• Preventing childhood obesity

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The Expanded Food and Nutrition Education Program (EFNEP) consistently leads to immediate improvements in nutrition-related behaviors among participants, as shown in 30 eligible studies with sample sizes ranging from 35 to 122,961.

However, the long-term retention of these behavior changes is lacking, indicating a need for better program design and evaluation methods to ensure lasting impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Expanded Food and Nutrition Education Program in Changing Nutrition-Related Outcomes Among Adults With Low Income: A Systematic Review. Atoloye, AT., Savoie-Roskos, MR., Guenther, PM., et al.[2021]

The American Dietetic Association emphasizes that all children and adolescents should have access to food and nutrition programs to support their physical, cognitive, and social development, highlighting the importance of these programs in preventing malnutrition and obesity.

Food and nutrition programs not only combat hunger and food insecurity but also provide essential nutrition education and promote physical activity, which are crucial for preventing chronic diseases in young populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position of the American Dietetic Association: child and adolescent food and nutrition programs. Stang, J., Bayerl, CT.[2022]

Access to federally funded nutrition assistance programs is crucial for ensuring that children and adolescents receive safe and healthy foods necessary for their growth and development, helping to combat hunger and food insecurity.

These programs not only provide essential nutrition but also play a significant role in preventing obesity and chronic diseases, highlighting the need for permanent federal funding to support their positive impact on child and adolescent health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position of the Academy of Nutrition and Dietetics: Child and Adolescent Federally Funded Nutrition Assistance Programs. Roy, PG., Stretch, T.[2019]

A systematic review of 10 studies on food provision programs for patients with type 2 diabetes or prediabetes showed that those including nutrition education consistently reduced HbA1c levels, indicating improved diabetes management.

Programs varied widely in their design and implementation, but those that incorporated nutrition education—covering topics like general nutrition and fruit/vegetable consumption—tended to yield better dietary quality and health outcomes compared to those without such education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A narrative review of clinic-community food provision interventions aimed at improving diabetes outcomes among food-insecure adults: examining the role of nutrition education. Schier, HE., Chetty, KS., Garrity, K., et al.[2023]

A study involving 41 women found that dietary recalls (24HDRs) collected by trained paraprofessional educators were comparable to those collected by registered dietitian nutritionists (RDNs), indicating that paraprofessionals can effectively gather dietary data.

The study suggests that using paraprofessional educators for dietary data collection allows RDNs to focus on more complex tasks, such as data evaluation and program development, enhancing the efficiency of nutrition education programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Similar 24-Hour Dietary Recall Results from Low-Income Women When Collected by a Paraprofessional Nutrition Educator or Registered Dietitian Nutritionist. Gills, SMH., Auld, G., Hess, A., et al.[2020]

A pilot food prescription program called Fresh Start Food Rx provided biweekly fresh fruits and vegetables and dietary education to four uninsured patients in South Miami, showing potential to improve dietary behaviors and attitudes toward healthy eating.

Participants reported an increase in the number of days they consumed fruits per week and a rise in vegetable servings, indicating that access to healthy foods and education can positively influence eating habits and perceptions about nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prompting a Fresh Start for Adults With Food Insecurity and Increased BMI: A Case Series of Four Patients in a Food Prescription Program. Oliveira, JB., To, L., De La Cruz, Y., et al.[2021]

The 'Cooking with Kids' program targets obesity prevention in urban African-American children by teaching children aged 6 to 11 how to prepare healthy meals while their mothers shop, addressing poor dietary choices prevalent in the community.

This initiative is particularly important as African-American girls face higher risks of obesity and related health issues, emphasizing the need for early intervention in promoting healthy eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Healthy Eating Among African-American School-Aged Girls in a Community Setting. Doswell, WM., Gibson, JL., Braxter, BJ., et al.[2022]

Healthcare provider education often lacks sufficient nutrition training, which is crucial for managing chronic diseases effectively.

An interprofessional nutrition education course was successfully created and implemented for healthcare students, focusing on evidence-based nutrition interventions to improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Dinner-Table Approach to a Unique Interactive Nutrition Curriculum for Healthcare Professional Students. An, SJ., Bleicher, I., Yu, Q., et al.[2021]

The Food As Medicine (FAME) initiative successfully engaged children in hands-on cooking and nutrition education, leading to increased enthusiasm for trying new foods and assisting with meal preparation at home.

The pilot program demonstrated that involving children in nutrition education can positively influence family dietary habits, encouraging healthier eating practices among low-income families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food as Medicine: A Pilot Nutrition and Cooking Curriculum for Children of Participants in a Community-Based Culinary Medicine Class. Marshall, H., Albin, J.[2021]

The 'Community Cooks' peer mentor model for delivering nutrition education in emergency food pantries was found to empower mentors and provide tailored, accessible recipes for food-insecure households, enhancing community engagement.

Despite the program's successes, a significant challenge was the low engagement of community members in the nutrition workshops, indicating a need for further research to improve participation and measure the program's impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successes and challenges of using a peer Mentor model for nutrition education within a food pantry: a qualitative study. Oliver, TL., McKeever, A., Shenkman, R., et al.[2022]

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 medicine programs, which include teaching kitchens and gardens, have shown promising preliminary outcomes in improving health metrics like weight and cardiometabolic risk factors in pediatric patients dealing with obesity.

Participation in culinary medicine workshops has increased healthcare employees' confidence and knowledge in preparing whole plant-based meals, suggesting that such programs can enhance healthy lifestyle behaviors both in patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching Kitchens and Culinary Gardens as Integral Components of Healthcare Facilities Providing Whole Person Care: A Commentary. Fals, AM., Brennan, AM.[2023]

Citations

1. cuimc.columbia.edu cuimc.columbia.edu/news/food-farmacia-breaks-link-between-food-insecurity-and-obesity-children

Food FARMacia Breaks the Link Between Food Insecurity ... “Our study is the first to show that directly providing fresh and healthy foods through a mobile food pantry protects against childhood obesity ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10159907/

a Propensity Score Matched Cohort Study A pediatric primary care-based mobile food pantry program was associated with significant smaller increases in child BMIz over 6 months.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8912842/

Mobile Food Pantry to Reduce Household Food Insecurity ... We used descriptive statistics and bivariate analyses to assess outcomes. Among 650 pediatric patients, 172 reported household food insecurity ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/ijpo.13023

Association of a primary care‐based mobile food pantry ... A paediatric primary care-based mobile food pantry program was associated with improvement in child BMIz over 6 months.

5. researchgate.net researchgate.net/publication/358999144_Feasibility_of_Food_FARMacia_Mobile_Food_Pantry_to_Reduce_Household_Food_Insecurity_in_Pediatric_Primary_Care

(PDF) Feasibility of Food FARMacia: Mobile Food Pantry to ... We used descriptive statistics and bivariate analyses to assess outcomes. Among 650 pediatric patients, 172 reported household food insecurity ...