228 Participants Needed

Grocery Interventions for Childhood Obesity

(NOURISH Trial)

SB
JH
Overseen ByJanna Howard, MPH
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12678

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.
See 1 more

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.
See 2 more

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?
2Treatment groups
Active Control
Group I: Grocery Benefit GroupActive Control1 Intervention
Group II: Cash Benefit GroupActive Control1 Intervention

Find a Clinic Near You

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.
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.
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.
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]

Citations

Grocery store access and childhood obesity - PubMed CentralThis systematic review and meta‐analysis suggested that access to grocery stores may have a rather small influence on child weight.
Association Between a Policy to Subsidize Supermarkets ...Subsidization of supermarkets may contribute to a small decrease in obesity risk among children residing near those supermarkets, if part of a ...
Grocery store interventions to change food purchasing ...Here we focus on randomized controlled trials (RCTs) that evaluated the effectiveness of interventions implemented in grocery stores to change purchasing ...
Nutrition and Obesity in Under-Represented Populations ...The primary endpoint is difference in BMI at 12 months post-enrollment (24 months of age). Secondary outcomes include measures of nutrition, ...
The impact of the consumer and neighbourhood food ...The availability and distance to healthy food outlets significantly improved children's dietary intake and BMI but null results were found for adults.
The Effects of Food Environment on Obesity in ChildrenThis review aims to highlight the relationship between residing in a food desert or a similar environment on body mass index (BMI) in school-aged children.
Grocery intervention and DNA‐based assessment to ...Results Intervention demonstrated changes across all assessed diet components and was more effective than usual care in increasing whole grain ( ...
Understanding family food purchasing behaviour of low ...This study explored parents' capability, opportunities, and motivations regarding food purchasing for their families, as well as barriers and facilitators.
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