About this trial

Not having enough food for each person in a household, also called food insecurity, makes it hard to eat a nutritious diet, maintain a healthy weight, and manage diabetes risk. Food banks and pantries provide direct food assistance that can mitigate food insecurity among people with lower income, however, people that utilize these organizations face time, resource, and physical constraints that limit their ability to consistently select and cook healthier meals and the organizations face budget constraints that limit their bandwidth for implementing nutrition programs. This research will test four innovative nutrition programs (nutritious prepared meals, medically tailored groceries in the form of meal kits, culinary medicine, motivational text messages) to identify which are the most effective for supporting healthy eating and food security and the most cost effective for organizations to implement, as an effort to reduce diabetes risk, improve diabetes self-management, and diminish health disparities.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18+,

Body mass index (BMI)≥ 25;

Access to a device with SMS and MMS (picture) text and Wi-Fi capabilities (e.g., phone, tablet, computer) and willingness to use the device regularly during the study;

Willingness to complete four in-person data collection appointments;

Disqualifiers

Presence of a condition or dietary restriction precluding eating study meals or weight loss (e.g., condition requiring liquid diet, pregnancy);

Another member of the household participating;

Planning to move within the next 12 months;

Unwilling to participate.

Trial design

Design model

Factorial

Treatments tested in this trial

Meal kits
Behavioral
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
No-prep meals
Behavioral
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases. Each entree has at least one serving of proteins, whole grains, and two vegetables. Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
Culinary nutrition classes
Behavioral
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes.
Text messages
Behavioral
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research. Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).

Treatment groups

400 Participants

are divided into 16 treatment groups

16

Treatment groups

See each treatment group below.

Group A: Condition 1: Pantry, MTG, No-prep meals, Culinary classes, and SMSExperimental treatment 4 interventions

Group B: Condition 2: Pantry, MTG, No-prep meals, and Culinary classesExperimental treatment 3 interventions

Group C: Condition 3: Pantry, MTG, No-prep meals, and SMSExperimental treatment 3 interventions

Group D: Condition 4: Pantry, MTG, and No-prep mealsExperimental treatment 2 interventions

Group E: Condition 5: Pantry, MTG, Culinary classes, and SMSExperimental treatment 3 interventions

Group F: Condition 6: Pantry, MTG, and Culinary classesExperimental treatment 2 interventions

Group G: Condition 7: Pantry, MTG, and SMSExperimental treatment 2 interventions

Group H: Condition 8: Pantry and MTGExperimental treatment 1 intervention

Group I: Condition 9: Pantry, No-prep meals, Culinary classes, and SMSExperimental treatment 3 interventions

Group J: Condition 10: Pantry, No-prep meals, and Culinary classesExperimental treatment 2 interventions

Group K: Condition 11: Pantry, No-prep meals, and SMSExperimental treatment 2 interventions

Group L: Condition 12: Pantry and No-prep mealsExperimental treatment 1 intervention

Group M: Condition 13: Pantry, Culinary classes, and SMSExperimental treatment 2 interventions

Group N: Condition 14: Pantry and Culinary classesExperimental treatment 1 intervention

Group O: Condition 15: Pantry and SMSExperimental treatment 1 intervention

Group P: Condition 16: Pantry onlyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Diet

24-hour recall based on recommendations from the National Cancer Institute and prior evidence suggesting feasibility and validity of the measure with Spanish speakers. Diet will be assessed using 24-hour recall administered via the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) in English and Spanish. Will be used to calculate a Healthy Eating Index (HEI) score. The HEI is a scale from 0 to 100.

Time frame

Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period (Appt 3, month 6), and three months post-intervention (Appt 4, month 9).

Secondary outcomes

1

Household food security

Measured using the USDA 6-item household food security survey and will be treated as a continuous variable if normally distributed or a categorical variable if data is non-normal. Categorical scoring will be based on USDA recommendations (0-1 affirmative responses = high or marginal food security, 2-4 = low food security, 5-6 = very low food security).

Time frame

Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period (Appt 3, month 6), and three months post-intervention (Appt 4, month 9).

2

Percent body weight change

Will be calculated as (Baseline weight minus follow-up weight) / (Baseline weight) x 100. Height and weight will be measured using an externally validated and calibrated Tanita DC-240MA scale.

Time frame

Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period(Appt 3, month 6), and three months post-intervention (Appt 4, month 9).

3

Hemoglobin A1C (HbA1c)

Will be measured using the externally validated point-of-care instrument, DCA VantageAnalyzer (1μl finger stick, nonfasting). This method has been implemented in food pantries and is less invasive and more cost effective than a venous blood draw.

Time frame

Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period(Appt 3, month 6), and three months post-intervention (Appt 4, month 9).

Other outcomes

1

Adherence

Number of meal kits eaten by the participant per month divided by number of meal kits selected per month, number of no-prep meals eaten per month divided by number of no-prep meals selected per month, number of culinary nutrition classes completed, and number of texts read.

Time frame

Through study completion, an average of 6 months (Baseline through 6 months)

2

Implementation Outcomes

Will measure early-stage implementation outcomes with the follow-up questionnaire (acceptability \[intervention satisfaction measures\] and through administrative tracking: intervention fidelity (adherence to assigned intervention components \[e.g., eating meals, attending classes, etc.\] and study protocols \[e.g., attending appointments\]).

Time frame

The entirety of the participant being enrolled (6 months)

Nutrition Intervention Optimization to Better Utilize Resources and Support Health

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts