Healthy Food Delivery + Lifestyle Intervention for Diabetes

(ADELANTE Trial)

Overseen By Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Substance use, Psychotic disorders, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 23

Duration: 12 months

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program that includes weekly healthy food deliveries and lifestyle coaching via Zoom to improve blood sugar control for Latino individuals with type 2 diabetes. Researchers aim to determine if this approach is more effective than regular care over six months. They will also examine its impact on food insecurity, eating habits, and mental well-being. This trial suits Latino residents of Alameda or Contra Costa County who have type 2 diabetes and face food insecurity. As an unphased trial, it provides a unique opportunity to explore innovative care strategies that could enhance health and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this multi-level intervention is safe for Latino patients with diabetes?

Research has shown that healthy food delivery systems can improve nutrition and reduce stress for people with diabetes. One study found that while a monthly voucher for healthy foods did not help control diabetes, home-delivered food boxes improved food security and eating habits. This suggests that regular food deliveries, like those used in the study, might be safe and manageable.

In the Vida Sana program, participants have experienced benefits such as weight loss and improved blood sugar levels (HbA1c). This program is culturally tailored and promotes healthy living through diet and exercise. It has successfully improved overall health without major safety concerns.

Both the food delivery and Vida Sana components appear safe based on past research. There have been no significant reports of negative effects, and participants generally accept them well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Vida Sana intervention for diabetes because it combines healthy food deliveries with a lifestyle coaching program, which is a fresh approach compared to standard treatments like medication and dietary advice alone. Most diabetes treatments focus on medication to control blood sugar, but Vida Sana targets behavior and diet directly through personalized coaching via Zoom, making it accessible and culturally relevant. This dual approach aims to empower individuals to make sustainable lifestyle changes, potentially offering more holistic benefits than traditional methods.

What evidence suggests that this trial's treatments could be effective for diabetes?

Research shows that delivering healthy food to people's homes can help manage type 2 diabetes by improving diet quality and ensuring adequate nutrition. In this trial, the Food and Lifestyle Intervention Group will receive these healthy food deliveries, which include foods beneficial for managing diabetes and controlling blood sugar levels. Additionally, this group will participate in the Vida Sana lifestyle program, which has effectively helped Latino patients lose weight and become more active. The program encourages losing at least 5% of body weight and engaging in 150 minutes of exercise each week, which can improve diabetes management. Together, the healthy food deliveries and the Vida Sana program aim to enhance blood sugar control and reduce food insecurity, making them promising strategies for managing diabetes. Meanwhile, the Waitlist Control Group will continue usual care without intervention for 6 months before receiving the healthy food box deliveries. ^{1 2 6 7 8}

Who Is on the Research Team?

Lisa Goldman Rosas, PhD, MPH

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for Latino individuals with type 2 diabetes who experience food insecurity, live in Alameda or Contra Costa County, and are involved in their household's nutrition. They must have a BMI of 25 or higher, be over 18 years old, not pregnant nor planning pregnancy within a year, and able to give informed consent.

Inclusion Criteria

Willing to complete some questionnaires and attend a single group session for household members

Your body mass index (BMI) is 25 or higher.

Self-identified ethnicity: Hispanic, Latino, Chicano, or Spanish

Exclusion Criteria

You plan to move away from the area in the next year.

You are currently using drugs or have a mental disorder that would make it hard for you to take part in a group program or complete follow-up check-ups.

Index participant only: Pregnant or planning to become pregnant within the next 12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly household food delivery and a 12-month remotely delivered lifestyle intervention, Vida Sana, which includes 23 group sessions over 12 months.

12 months

23 group sessions (virtual)

Control

Waitlist control group receives usual care for 6 months, followed by food box deliveries for 6 months.

12 months

Follow-up

Participants are monitored for changes in glycemic control, physical activity, and dietary behaviors.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Supplemental Healthy Food Deliveries
• Vida Sana

Trial Overview

ADELANTE is testing if weekly healthy food deliveries combined with an intensive lifestyle intervention (Vida Sana) can better improve blood sugar control compared to usual care among Latinos with diabetes after six months.

How Is the Trial Designed?

Group I: Waitlist Control Group Experimental Treatment 1 Intervention

The waitlist control will continue usual care with no intervention for 6 months. To balance rigor with ethical considerations, they will receive the healthy food box deliveries after a 6 month waiting period.

Group II: Food and Lifestyle Intervention Group Experimental Treatment 2 Interventions

The Food and Lifestyle Intervention Group will receive weekly household deliveries of healthy food as well as a lifestyle intervention (called Vida Sana) that will be delivered via Zoom and facilitated by a trained bilingual/bicultural health coach.

Vida Sana is already approved in United States for the following indications:

Approved in United States as Vida Sana for:

• Obesity prevention and management
• Diabetes prevention

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Yeyi Organics

Collaborator

Trials

1

Recruited

360+

La Clínica de La Raza Inc.

Collaborator

Trials

4

Recruited

1,100+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dig Deep Farms

Collaborator

Trials

1

Recruited

360+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

A 3-month produce prescription program for 303 predominantly Hispanic/Latino adults with or at risk of type 2 diabetes led to significant reductions in weight, waist circumference, and systolic blood pressure, indicating improved cardio-metabolic health.

Participants with higher baseline HbA1c levels experienced a notable decrease in HbA1c, alongside improvements in food security and mental health measures, suggesting that access to fresh produce can positively impact both physical and psychological well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal changes in bio-behavioral and glycemic outcomes following a produce prescription program among predominantly Hispanic/Latino adults with or at risk of type 2 diabetes. Sato Imuro, SE., Sabharwal, A., Conneely, C., et al.[2023]

The Vida Sana study is a 5-year randomized controlled trial involving 186 overweight or obese Latino adults with metabolic syndrome or pre-diabetes, testing a culturally adapted Diabetes Prevention Program to address obesity and diabetes disparities.

The primary goal is to assess the intervention's effectiveness in reducing weight over 24 months compared to usual care, while also evaluating its impact on cardiometabolic risk factors and psychosocial well-being, providing valuable insights for diabetes prevention in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a culturally-adapted lifestyle intervention to treat elevated cardiometabolic risk of Latino adults in primary care (Vida Sana): A randomized controlled trial. Rosas, LG., Lv, N., Xiao, L., et al.[2022]

A systematic review of 44 studies found that interventions promoting fruit and vegetable intake can lead to small but significant increases in consumption, particularly in individuals with preexisting health conditions, with increases ranging from 0.1 to 1.4 servings per day.

Face-to-face education and counseling were the most effective methods for increasing intake, while community-based multicomponent interventions also showed positive results, indicating that various approaches can be effective in promoting healthier eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions designed to increase adult fruit and vegetable intake can be effective: a systematic review of the literature. Pomerleau, J., Lock, K., Knai, C., et al.[2023]

The 'Vida Sana' web platform was effective in improving key health metrics, such as lowering fasting blood glucose and body fat percentage, in a study of 77 Mexican individuals at risk for type 2 diabetes over a 3-month period.

Despite its effectiveness, the platform had a low feasibility rate of 42%, with barriers including difficulty accessing the platform and lack of time or interest, suggesting that enhancing usability could increase its acceptance in middle-income populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Web Platform to Record Lifestyle Habits in Subjects at Risk of Developing Type 2 Diabetes in a Middle-Income Population: Prospective Interventional Study. Sevilla-Gonzalez, MDR., Bourguet-Ramirez, B., Lazaro-Carrera, LS., et al.[2022]

The Life! program, a large-scale diabetes prevention initiative in Australia, successfully engaged over 29,000 individuals, with 8,412 participants starting the program and 37% completing it over 8 months.

Participants who completed the program experienced significant weight loss, averaging 2.4 kg (2.7% of their starting body weight) and a reduction in waist circumference, indicating the program's efficacy in promoting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scaling up diabetes prevention in Victoria, Australia: policy development, implementation, and evaluation. Dunbar, JA., Jayawardena, A., Johnson, G., et al.[2019]

A pilot food prescription program called Fresh Start Food Rx provided biweekly fresh fruits and vegetables and dietary education to four uninsured patients in South Miami, showing potential to improve dietary behaviors and attitudes toward healthy eating.

Participants reported an increase in the number of days they consumed fruits per week and a rise in vegetable servings, indicating that access to healthy foods and education can positively influence eating habits and perceptions about nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prompting a Fresh Start for Adults With Food Insecurity and Increased BMI: A Case Series of Four Patients in a Food Prescription Program. Oliveira, JB., To, L., De La Cruz, Y., et al.[2021]

A study involving 171 community residents with metabolic syndrome showed that a 5-month initiation health program significantly improved lifestyle and laboratory test results, with benefits sustained over a 2-year follow-up.

Both the initiation program and a subsequent 6-month enhancing program led to similar improvements, indicating that even the shorter program was effective in promoting healthier lifestyles among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An intervention study to promote self-improvement of lifestyle in a Japanese community: a new health support program. Fukumoto, K., Wei, CN., Matsuo, H., et al.[2021]

A multidisciplinary cooking program at a health center significantly improved participants' cooking self-efficacy and diet-related self-management strategies, with 44% reporting increased vegetable consumption after attending the classes.

Participants felt a strong sense of community, with 100% feeling valued in their cooking group, highlighting the program's effectiveness in fostering social connections alongside dietary education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross-Sector Partnerships for Improved Cooking Skills, Dietary Behaviors, and Belonging: Findings from a Produce Prescription and Cooking Education Pilot Program at a Federally Qualified Health Center. Ylitalo, KR., Janda, KM., Clavon, R., et al.[2023]

Participants in a medically-tailored meal program for individuals with type 2 diabetes reported high satisfaction and noted improvements in their quality of life and diabetes management, highlighting the program's effectiveness.

The study emphasized the importance of culturally appropriate meals and suggested that combining these meal programs with diabetes education could enhance their impact on managing diabetes and reducing stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. Berkowitz, SA., Shahid, NN., Terranova, J., et al.[2020]

Medically tailored meals (MTMs) have been shown to effectively improve health outcomes for food-insecure patients with type 2 diabetes, highlighting the importance of nutrition in diabetes management.

Improving access to nutritious food through MTMs not only benefits patient health but also has the potential to reduce overall healthcare costs, suggesting a need for further research to support insurance coverage for these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medically Tailored Meals as a Prescription for Treatment of Food-Insecure Type 2 Diabetics. Rabaut, LJ.[2020]

A study involving 568 adults with diabetes showed that providing diabetes-appropriate food and self-management support through food banks improved food security and fruit and vegetable intake, but did not significantly lower hemoglobin A1c (HbA1c) levels after 6 months.

While the intervention improved aspects of food stability and dietary intake, it did not lead to measurable changes in self-management behaviors or overall glycemic control, indicating that further research is needed to enhance the effectiveness of community-based diabetes support programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Diabetes Self-Management Support From Food Banks: A Randomized Controlled Trial. Seligman, HK., Smith, M., Rosenmoss, S., et al.[2020]

This study will evaluate the efficacy of a Medically Tailored Meals (MTM) program for individuals with type 2 diabetes and hyperglycemia, involving 212 participants over 26 weeks, to see if it can improve their blood sugar levels and overall health.

The trial aims to provide valuable data on the clinical outcomes of MTM, which could support its large-scale implementation in healthcare systems to help manage chronic conditions like diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia. Law, KK., Coyle, DH., Neal, B., et al.[2023]

A computer-assisted self-management intervention for type 2 diabetes patients (n=335) led to significant reductions in dietary fat intake and weight compared to usual care at the 2-month follow-up.

The intervention was feasible and well-implemented, showing promise for improving lifestyle behaviors in diabetes management, although changes in HbA1c and lipids did not reach statistical significance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a brief computer-assisted diabetes self-management intervention on dietary, biological and quality-of-life outcomes. Glasgow, RE., Nutting, PA., Toobert, DJ., et al.[2017]

The pilot low-calorie diet programs for Type 2 Diabetes showed that while most service parameters were followed, there was a notable loss of fidelity in some areas, which could affect the overall success of the programs.

Across four service providers, 74% to 87% of the required behavior change techniques (BCTs) were included, with significant variation in the presence and dosage of additional BCTs, indicating inconsistencies that may impact program outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the design of the NHS Low-Calorie Diet Programme have fidelity to the programme specification? A documentary review of service parameters and behaviour change content in a type 2 diabetes intervention. Evans, TS., Dhir, P., Radley, D., et al.[2023]

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