Grocery Interventions for Childhood Obesity

(NOURISH Trial)

Overseen By Janna Howard, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Monogenic obesity, Moving, Pregnancy

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

Compensation: Varies

Number of Visits: 3

228 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether resolving food insecurity in young children with early-onset obesity can improve their body mass index (BMI) over a year. Participants will receive $50 a week, either as unrestricted cash or as a grocery benefit with guidance from a nutrition expert (referred to as "Grocery intervention - restricted"). The study seeks to determine which method more effectively improves BMI and other health factors, such as nutrition and stress. Families with infants aged 9-12 months who are eligible for Medicaid and WIC and have a high BMI might be a good fit. As an unphased trial, this study offers families the chance to contribute to important research that could lead to better health outcomes for children facing similar challenges.

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 shows that access to grocery stores doesn't greatly affect children's weight. This suggests that the grocery guidance program is likely safe, as it focuses on teaching families how to shop for healthy foods. One study found that helping people improve their diet through grocery support increased their intake of healthy foods, with no major side effects reported.

For the cash benefit program, research indicates that financial help can reduce food insecurity without major safety concerns. Although direct evidence on the safety of this specific program is limited, similar approaches in other studies haven't been linked to harmful effects.

Overall, both programs aim to help families achieve better nutrition with minimal risk. Participants in similar programs have not reported significant negative events, suggesting these programs are well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for childhood obesity because they explore new ways to influence healthy eating habits directly at the grocery store, a setting where many families make food choices. Unlike traditional approaches that might focus on education or exercise alone, these interventions provide financial assistance tailored to grocery shopping. The "Grocery Benefit Group" links benefits to specific grocery items, encouraging healthier purchases, while the "Cash Benefit Group" offers flexibility with unrestricted cash, giving families the freedom to choose and learn through practical decision-making. By connecting financial support with real-world shopping experiences, these interventions aim to empower families to make healthier choices consistently.

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

This trial compares two approaches to grocery interventions for childhood obesity. The Grocery Benefit Group offers financial support through a grocery benefit, providing participants with $50 worth of groceries weekly. Research has shown that proximity to grocery stores slightly affects children's weight, as access to stores with healthy food can improve dietary habits and Body Mass Index (BMI).

The Cash Benefit Group offers financial support through an unrestricted cash benefit, with participants receiving $50 weekly. Evidence suggests that programs providing families with unrestricted cash can reduce the consumption of unhealthy snacks and drinks, potentially lowering obesity. Overall, both approaches in this trial aim to improve access to healthy food and choices, potentially leading to healthier weights in children. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for infants aged 9-12 months at risk of food insecurity and early-onset obesity, with a BMI ≥ 95th percentile. They must be Medicaid and WIC-eligible, not involved in other nutrition programs, and their caregiver should speak English or Spanish. Infants with certain medical conditions or plans to move are excluded.

Inclusion Criteria

My baby was born full-term and their weight was within the normal range for their sex.

My BMI is in the top 5% for my age and sex, indicating early-onset obesity.

My child is between 9 to 12 months old and I am their primary caregiver.

Exclusion Criteria

Parent is currently pregnant

I have been diagnosed with obesity caused by a single gene.

I have a condition that affects my growth or feeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either a cash benefit or a grocery benefit for 12 months

12 months

Weekly interactions for grocery benefit group

Follow-up

Participants are monitored for changes in BMI and other health metrics

12 months

Assessments at baseline, 3, 6, 9, and 12 months

Post-study Interviews

Participants report on intervention satisfaction and barriers of infant feeding

What Are the Treatments Tested in This Trial?

Interventions

• Grocery intervention - restricted
• Grocery intervention - unrestricted

Trial Overview

The study tests if resolving food insecurity affects infant BMI over one year through two interventions: $50/week as unrestricted cash or the same amount for guided healthy grocery purchases. The goal is to compare these methods' effectiveness on children's health outcomes.

How Is the Trial Designed?

Group I: Grocery Benefit Group Active Control 1 Intervention

Provides financial support weekly in the form of a grocery benefit. The investigators will enroll participants in the Food Lion MVP program, linking the account to a Duke email address. The study team will work with the participants to order $50 worth of groceries from Food Lion, for the participants to pick up from the store. Groceries will be ordered weekly for the 12 months of enrollment and coordinators will have access to view items purchased at Food Lion by each participant.

Group II: Cash Benefit Group Active Control 1 Intervention

Provides financial support weekly, in the form of an unrestricted cash benefit. The investigators will partner with Held to provide the card to participants, load the card with $50/week for the 12 months of enrollment, and view the purchases at the vendor level using an existing dashboard Held maintains. Participants will also receive a monthly nutrition guidance brochure tailored to the infant's developmental stage.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

The Healthy School Start Plus intervention, involving 352 six-year-old children across 17 schools, aims to prevent obesity by promoting healthy eating and physical activity through parental involvement and support from teachers and school nurses.

This 6-month program is based on Social Cognitive Theory and includes health information for parents, motivational interviewing, classroom activities, and a web-based diabetes risk self-test, with the expectation that it will be more effective than standard care in improving children's dietary habits and physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Healthy School Start Plus for prevention of childhood overweight and obesity in disadvantaged areas through parental support in the school setting - study protocol for a parallel group cluster randomised trial. Elinder, LS., Patterson, E., Nyberg, G., et al.[2019]

A randomized trial involving 33 supermarkets in low-income, high-minority neighborhoods tested healthy food marketing strategies over 18 months, showing high compliance (76.5%) with these strategies.

The study aimed to promote healthier food purchases, but pre-intervention sales of healthier items were similar in both intervention and control stores, indicating that simply increasing healthy food availability may not be enough to change purchasing habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The healthy food marketing strategies study: design, baseline characteristics, and supermarket compliance. Glanz, K., Chung, A., Morales, KH., et al.[2022]

The B'more Healthy Communities for Kids (BHCK) intervention successfully improved the availability and purchasing of healthier foods in low-income neighborhoods, with significant increases in sales of promoted products at wholesalers and improved stocking in corner stores.

Children exposed to the intervention showed an increased frequency of purchasing healthier foods, indicating that multilevel community interventions can positively influence food choices among children in urban food deserts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of a Multi-Level Multi-Component Childhood Obesity Prevention Intervention on Healthy Food Availability, Sales, and Purchasing in a Low-Income Urban Area. Gittelsohn, J., Trude, AC., Poirier, L., et al.[2022]

A study involving 247 participants showed that supermarket-based dietary interventions, particularly those led by dietitians and enhanced with online tools, significantly improved adherence to the DASH diet over 3 months, with a notable increase in DASH scores compared to a control group.

The more comprehensive Strategy 2, which included online shopping tools and meal planning, resulted in a greater improvement in dietary quality than the simpler Strategy 1, highlighting the effectiveness of integrating technology into dietary education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of supermarket and web-based interventions for improving dietary quality: a randomized, controlled trial. Steen, DL., Helsley, RN., Bhatt, DL., et al.[2023]

Nutritional scoring and messaging are the most effective strategies for promoting healthier food purchases in U.S. grocery stores, particularly in SNAP-authorized settings, based on a review of 73 studies.

Simple intervention strategies tend to be more successful and less burdensome for shoppers, suggesting they should be prioritized for policy implementation in grocery retail environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Encouraging Healthier Food and Beverage Purchasing and Consumption: A Review of Interventions within Grocery Retail Settings. Wolgast, H., Halverson, MM., Kennedy, N., et al.[2022]

A review of 58 articles identified 33 interventions in supermarkets and grocery stores aimed at promoting healthful food choices, with the most effective strategy being a combination of point-of-purchase promotions and advertising.

While some intervention categories showed sufficient evidence for effectiveness, overall, none of the strategies demonstrated strong evidence, highlighting the need for more rigorous testing to assess their impact on dietary and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supermarket and grocery store-based interventions to promote healthful food choices and eating practices: a systematic review. Escaron, AL., Meinen, AM., Nitzke, SA., et al.[2022]

The 'Plate It Up Kentucky' intervention in 10 supermarkets led to an 8% increase in spending on fruits and vegetables among rural customers, indicating improved healthy food purchasing behavior.

Customers in intervention stores also significantly reduced their spending on sugar-sweetened beverages (SSBs) from $2.75 to $1.81, suggesting that the intervention not only promoted healthier food choices but also discouraged less healthy options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between the "Plate it Up Kentucky" supermarket intervention and changes in grocery shopping practices among rural residents. Gustafson, A., Ng, SW., Jilcott Pitts, S.[2020]

The Eat Right-Live Well! intervention successfully implemented various strategies to promote healthy food purchasing in a Southwest Baltimore supermarket, with high fidelity in stocking, labeling, and advertising healthy foods.

Community outreach events had a strong impact, but employee training did not significantly improve staff knowledge or ability to assist customers in making healthy choices, suggesting a need for better management involvement to enhance overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Process Evaluation of a Comprehensive Supermarket Intervention in a Low-Income Baltimore Community. Lee, RM., Rothstein, JD., Gergen, J., et al.[2022]

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