Optimization Trial to Empower sElection of Nutritious Foods

ConditionsFood Insecurity Healthy Eating

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age12+

SponsorNew York University

About this trial

Type 2 diabetes (T2D) disproportionately affects Black and Hispanic youth compared to their White peers. Although prediabetes can rapidly progress, youth who maintain or lose weight are able to revert the condition. Youth-led online Diabetes Prevention Programs (DPP) show promise for improving healthy behaviors, but alone does not address systemic barriers, such as affordability, availability, and accessibility of healthy foods, hindering adoption of lifestyle changes. Low-income Black and Hispanic youth are more likely to live in communities with low access to affordable and healthy foods, that protect against T2D. Online grocery shopping has the potential to improve access by addressing transportation barriers. However, delivery fees and digital literacy may unintentionally widen inequities. To address these gaps, this proposal will leverage existing national programs (USDA's Online Purchasing Pilot and online-DPP) to test three experimental components (Youth-led Online DPP, Financial Incentive, Instant Shoppable List). This work will aim to 1) conduct formative research to gather barriers, facilitators of fruit, vegetable, and legume (FVL) purchase and consumption among ethnically diverse, low-income families with youth (12-17 years old); 2) determine the combination of intervention components that maximizes the effect on household purchase and youth consumption of FVL and sugar. A multiphase optimization strategy (MOST) on a 23 factorial randomized, controlled study will estimate both individual and interactive effects of each intervention component. This research will generate new knowledge about behavioral, social, cultural, environmental, and policy factors that influence healthy eating, which can be used to address disparities in obesity and T2D among low-income youth.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Factorial

Treatments tested in this trial

Video Tutorial
Behavioral
At the onset of the intervention, all participants will receive tutorial videos via text, covering Instacart account setup, online item selection, and SNAP-eligible stores, aiming to improve digital literacy in grocery shopping. The video was developed by the research team, reviewed by SNAP-Ed partners, and available in English and Spanish. Despite being considered helpful during the pilot, nearly half of the participants reported not receiving or watching the tutorial video. To address this, the research team will call all participants within the trial's first week to provide technical assistance, including step-by-step instructions on redemption of the free delivery membership. Phone follow-ups were well-received during the pilot. Also, an intervention package will be mailed to all participants as material to be referred to in the calls and throughout the intervention.
Delivery Fee Waiver
Behavioral
All participants will receive a 12-week Instacart+ Membership e-gift card, a monthly one-time use service fee waiver (3 in total) and a monthly one-time use $5 stipend (3 in total) eliminating the online delivery fee for orders \>$10.
Youth-led Wellness Program
Behavioral
The participants who are 12 to 17 years of age and are randomized to this component will participate in an online WhatsApp peer-led advocacy group focused on health promotion. Over the 12 weeks, different themes will be covered on a weekly basis with participants receiving engagement prompts 2 to 3 times a week and weekly activities with the aim to increase knowledge and self-efficacy, fostering sustainable behavior change in nutritional habits. All messages and activities are evidence-based and use the Social Cognitive Theory Model.
Financial Incentive
Behavioral
Participants randomized to this component (alone or in combination with another experimental condition) will receive $1 for each dollar spent on fresh, frozen, or canned FVL loaded onto Instacart Fresh Funds, verified based on the submitted online grocery receipt or data from Instacart. The incentive applies to online purchases only and will not be earned for in-store transactions. A maximum weekly matched incentive will be set to $10, following the local FV incentive NYC ("Get the Good Stuff"). Fresh Funds earned, supported by Instacart Health, is an infrastructure integrated with retailer payment systems. Incentives will only be used for purchases of healthier foods (FVL) predetermined by the research team, as it has been used by FV prescription programs.
Grocery List with Instant Shoppable SNAP-Ed Recipes
Behavioral
Participants randomized to this component will receive weekly SNAP-Ed-based meal plans with instant shoppable grocery lists tailored to household size, dietary, and cultural preferences. All recipes will emphasize FVL-based eating patterns with Hispanic cuisine influences that have FVL as primary ingredients. Grocery lists organized by store department and recipe, will reflect the nearest available in-store unit. For example, if one recipe calls for 1 cup of flour, a small flour bag will be added to the list. Weekly meal plans will be shared via text as a photo and mailed as hard copies, with instant shoppable lists generated through Instacart's List feature as a hyperlink. Links to the instant shoppable list will be shared via text. Upon clicking, grocery items will be pre-filled automatically in the participant's online shopping cart. Participants can modify items and quantities before checking out.

Treatment groups

200 Participants

are divided into 8 treatment groups

Treatment groups

See each treatment group below.

Group A: Youth-led Wellness Group + Financial Incentive + Shoppable ListExperimental treatment 5 interventions

Group B: Youth-led Wellness Program + Financial IncentiveExperimental treatment 4 interventions

Group C: Youth-led Wellness ProgramExperimental treatment 3 interventions

Group D: Financial Incentive + Shoppable ListExperimental treatment 4 interventions

Group E: Youth-led Wellness Program + Shoppable ListExperimental treatment 4 interventions

Group F: Shoppable ListExperimental treatment 3 interventions

Group G: Financial IncentiveExperimental treatment 3 interventions

Group H: Delivery fee waived onlyActive comparator 2 interventions

Trial outcomes

Primary outcomes

Household Purchase of Fruit, Vegetable, and Legumes

Change in household purchase of fruits, vegetables, and legumes (online and in-store) from baseline will be assessed via itemized grocery receipts obtained via text messages mid-intervention (6-week), post-intervention (12-week), and maintenance (12 months).

Time frame

6 weeks, 12 weeks, and 12 months

Secondary outcomes

Youth Consumption of Fruit, Vegetable, and Legumes

Change in consumption of fruits and vegetables from baseline will be assessed via self-reported questionnaires utilizing the Block Food Frequency (FFQ) questionnaire for youth reported online at baseline, 12-week from baseline and 12-months from baseline.

Time frame

12 weeks and 12 months

Parent/Caregiver Consumption of Fruit, Vegetable, and Legumes

Change in consumption of fruits and vegetables from baseline will be assessed via self-reported questionnaires utilizing the Dietary Screener Questionnaire (DSQ) for adults reported online at baseline and 12-weeks from baseline.

Time frame

12 weeks

Other outcomes

Body Mass Index

Change in Body Mass Index from baseline will be measured by self-reported height and weight from adults and youth at baseline and 12-week.

Time frame

12 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

New York University

Lead sponsor

Source ClinicalTrials.gov

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