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

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 Grocery Interventions for Childhood Obesity?

Research shows that interventions in grocery stores, like promoting healthier food options and providing recipe cards and samples, can lead to increased purchases of fruits and vegetables and decreased purchases of sugary drinks. These strategies have been effective in encouraging healthier food choices, which can help in managing obesity. ^{1 2 3 4 5}

Is the Grocery Interventions for Childhood Obesity treatment safe for humans?

The research on grocery interventions, including those involving dietary education and healthy food marketing, does not report any safety concerns for humans. These interventions focus on promoting healthier food choices and improving dietary quality, which are generally considered safe. ^{1 2 3 4 6}

How does the Grocery Interventions for Childhood Obesity treatment differ from other treatments for childhood obesity?

This treatment is unique because it focuses on modifying grocery purchasing behaviors to promote healthier food choices, which is different from traditional treatments that might focus on diet plans or physical activity alone. By intervening directly at the point of purchase, it aims to make healthier food options more accessible and appealing, potentially leading to more sustainable changes in eating habits. ^{2 3 5 7 8}

What is the purpose of this trial?

Food insecurity is associated with obesity in children, and childhood obesity leads to long term health consequences. While existing research shows that food benefit programs reduce food insecurity, little is known about the mediating factors between food benefit programs and child health. The purpose of this study is to understand if the resolution of food insecurity in young children with early onset obesity can improve body mass index (BMI) over one year, and if so, by what mechanisms. The investigators will conduct a randomized comparative effectiveness study among infants (n=228) aged 12 months at risk for food insecurity and deliver two different food security interventions. Both will provide families with $50/week for one year of study enrollment. The first group will receive this as an unrestricted cash benefit ("cash benefit group") and the second group will receive this as a benefit in the form of weekly grocery purchases with the support of a trained nutrition expert to guide healthy grocery purchasing ("grocery benefit group"). The investigators will also construct a contemporary comparison cohort of infants meeting the inclusion/exclusion criteria from the electronic health record, using propensity score matching to allow comparisons between both intervention groups and usual care. The primary endpoint is difference in BMI at 12 months post-enrollment (24 months of age). Secondary outcomes include measures of nutrition, food security, electronic health record data related to general child health, and other factors related to parental stress and unmet social needs. Patients will have the opportunity to participate in post-study interviews to report on intervention satisfaction, and facilitators and barriers of infant feeding. Data analysis will be conducted by a trained statistician (Duke Biostatistics, Epidemiology, and Research Design; BERD) and will employ a two-means test for a repeated-measures design. The benefits to participants outweigh the minimal risks of loss of privacy, and confidential information will be managed carefully to minimize this risk.

Eligibility Criteria

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

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

Parent is currently pregnant

I have a condition that affects my growth or feeding.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The healthy food marketing strategies study: design, baseline characteristics, and supermarket compliance. [2022]

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

Supermarket and grocery store-based interventions to promote healthful food choices and eating practices: a systematic review. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Encouraging Healthier Food and Beverage Purchasing and Consumption: A Review of Interventions within Grocery Retail Settings. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The association between the "Plate it Up Kentucky" supermarket intervention and changes in grocery shopping practices among rural residents. [2020]

5. Switzerland 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. [2022]

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

Efficacy of supermarket and web-based interventions for improving dietary quality: a randomized, controlled trial. [2023]

7. England 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. [2019]

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

Process Evaluation of a Comprehensive Supermarket Intervention in a Low-Income Baltimore Community. [2022]