DiabetesADELANTENCT05228860
Addressing Diabetes by Elevating Access to Nutrition
A study testing Vida Sana (a Group Lifestyle Intervention) and Supplemental Healthy Food Deliveries in people with Diabetes and Obesity, run by Stanford University at 1 site in United States.
Trial summary
The goal of ADELANTE is to determine whether a multi-level intervention to improve household food insecurity and glycemic control is effective for Latino patients with diabetes. Specifically, ADELANTE aims to 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Obesity, Lifestyle, Healthy
- What is being tested?
- Vida Sana (a Group Lifestyle Intervention) and Supplemental Healthy Food Deliveries
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For main study (index/intervention) participants:
- Age at enrollment: 18+ years
- Self-identified ethnicity: Hispanic, Latino, Chicano, or Spanish
- Type 2 diabetes indicated in the electronic health record, e.g. as ICD-10 (International Classification of Diseases) diagnosis code or HbA1c value
- Have indicated food insecurity according to the screening 2-item Hunger Vital Sign questionnaire
- Have a Body Mass Index (BMI) => 25
Show all 15Show fewer
- Receiving care at our partnering community health centers (e.g., Clinica de la Raza)
- Currently residing in Alameda or Contra Costa County and not expecting to relocate in the next 6-12 months
- Have access to phone or computer, email, and some internet for access to remote intervention and completion of follow-up measures
- For household members:
- Age at enrollment: 12+ years
- Significantly involved in supporting nutrition in the home including food shopping, preparation, social support for healthy nutrition
- Willing to complete some questionnaires and attend a single group session.
- For all participants:
- Able and willing to provide informed consent
Who cannot join
- Unable to provide informed consent
- Unable to speak, read, or understand English and/or Spanish
- Active substance use or psychotic disorders that would impair participation in a group lifestyle intervention or interfere with follow-up assessments
- Lacking mailing address for delivery of food box
- Planning to relocate out of area within the next 12 months
- Index participant only: Pregnant or planning to become pregnant within the next 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addressing Diabetes by Elevating Access to Nutrition: The ADELANTE Study
The goal of ADELANTE is to determine whether a multi-level intervention to improve household food insecurity and glycemic control is effective for Latino patients with diabetes.
Specifically, ADELANTE aims to
- determine whether weekly household food delivery plus an intensive lifestyle intervention is more effective than usual care for improving glycemic control (HbA1c) at 6 months,
- examine the effects of the multi-level intervention on = household food insecurity, dietary behaviors, and psychosocial outcomes, and
- assess the future potential for implementation and dissemination of this multi-level intervention in primary care settings.
Read the detailed description
Participants and up to two of their household members will be randomized to one of two groups:
- healthy food box home delivery for 12 weeks plus a 12-month remotely delivered lifestyle behavioral intervention, Vida Sana, which incorporates family members and is aligned with Latino cultural values, or
- a wait list control group who will receive the food box deliveries 6 months later (but not the Vida Sana intervention).
The first 6 months will evaluate the effects of receiving Vida Sana plus food delivery versus being randomized to control (no intervention); the final 6 months will evaluate receiving food delivery with versus without Vida Sana.
VIDA SANA (intervention arm):
The Vida Sana intervention is a cultural adaptation of Group Lifestyle Balance, a 12-month group program in turn adapted from the NIH/NIDDK-supported Diabetes Prevention Program (DPP). It has been shown to be effective in promoting clinically significant, modest weight loss and significant improvements in moderate-intensity physical activity. Participants receive a total of 23 group sessions over 12 months with a trained health coach who provides personalized feedback based on self-tracking.
The program emphasizes a) moderate caloric reduction by 500-1,000 calories per day through healthy substitutions, b) incremental increases in moderate physical activity such as brisk walking, and c) behavioral strategies to support successful adoption and maintenance of healthy behaviors. These behavioral strategies include realistic goal setting, fostering social support, and stress management. Study health coaches will also add COVID-specific topics to ensure that participants are equipped to change behavior and manage stress during the pandemic.
FOOD BOXES (intervention arm (immediately) and control arm (6 months later)):
Each healthy food box delivery will include a variety of seasonal produce and a rotation of different whole grain foods (3+ grams of fiber/serving) such as cereal, pasta, tortillas, bread, and crackers. Participants will receive familiar foods as well as (intentionally) unfamiliar items to encourage them to try new foods. All items are also available at low-cost grocery stores so participants can continue to purchase them after the end of the study if they wish. The quantity is scaled to three household sizes. It is intended to supplement a family's food supply and provide opportunities for trying new fiber-rich foods recommended by the Vida Sana intervention.
- Conditions
- Diabetes, Obesity, Lifestyle, Healthy
- Being tested
- Vida Sana (a Group Lifestyle Intervention), Supplemental Healthy Food Deliveries
- Keywords
- food insecurity, community health worker, health coach, weight loss, HbA1c, T2DM, glycemic control, multilevel
- Medical subject headings
- Diabetes Mellitus, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vida Sana (a Group Lifestyle Intervention)Behavioural
Vida Sana is a Group Lifestyle intervention that has been shown to be effective among patients with type 2 diabetes (T2DM). Vida Sana includes 23 group sessions with a trained health coach:
- Months 1-4: 1 family-wide orientation + 12 weekly sessions
- Months 5-6: 4 bimonthly group sessions
- Months 7-12: 6 monthly group sessions
All regular primary care and diabetes care will remain as usual.
Supplemental Healthy Food DeliveriesBehavioural
Participants will receive 12 weeks of weekly food deliveries from Dig Deep Farms.
Each delivery will include a selection of seasonal fresh vegetables and a rotation of either a whole grain or a whole-grain food (3+ grams of fiber/serving). Whole grains will include brown rice, oatmeal, barley, quinoa; whole grain foods will include cereal, pasta, tortillas, bread, crackers. Delivery sizes will be scaled to the three corresponding household sizes: 2-3 people; 4-5 people; or 6 or more people.
Food will be delivered by Dig Deep Farms, which already has an established food subscription delivery system.
(Control group participants will receive the same delivery schedule, but delayed to begin 6 months after their study enrollment.)
| Study group | Role | What they receive |
|---|---|---|
| Food and Lifestyle Intervention Group | Experimental | 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. Receives: Behavioral: Vida Sana (a Group Lifestyle Intervention); Behavioral: Supplemental Healthy Food Deliveries |
| Waitlist Control Group | Experimental | 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. Receives: Behavioral: Supplemental Healthy Food Deliveries |
What is being measured
The primary outcome is the main question the study is designed to answer.
HgbA1c
Study staff will gather fingerstick blood samples for HgbA1c.
Measured: Baseline through 12 months post-enrollment
Secondary outcomes (23)
nonHDL Cholesterol
Study staff will gather fingerstick blood samples for lipid measurements, focusing on non- HDL cholesterol (total minus HDL cholesterol) which is a valuable marker of atherogenic dyslipidemia in diabetic individuals that does not require a fasting state.
Measured: Baseline through 12 months post-enrollment
Blood Pressure
Blood pressure will be measured with an automated cuff with digital readout, or using a traditional sphygmomanometer. A study staff member will conduct the reading. Both systolic and diastolic pressure will be measured.
Measured: Baseline through 12 months post-enrollment
Change in Body Mass Index (BMI)
Weight (kg) and height (cm) will be measured and Body Mass Index (BMI) will be calculated in kg/m^2. Height and weight will be gathered using standardized protocols with a portable scale and stadiometer. At baseline, these will be measured in triplicate for accuracy.
Measured: Baseline through 12 months post-enrollment
Change in waist-height ratio
Waist-height ratio (cm) will be calculated and compared over time. Waist circumference (cm) will be measured at iliac crest. Height (cm) will be measured using standardized protocols.
Measured: Baseline through 12 months post-enrollment
Pandemic-Related Perceived Stress Scale of COVID-19 (PSS-10-C)
Participants will answer 10 questions about their stress related to the pandemic. Scale is made up of 10 items, each of which offers five response options: never, almost never, occasionally, almost always and always. Items 1, 2, 3, 6, 9 and 10 are scored directly from 0 to 4 and items 4, 5, 7 and 8, conversely, from 4 to 0.
Scores range from 0 to 40, higher scores indicating greater stress.
The PSS-10-C was adapted from the Scale of Perceived Stress (PSS-10) and independently validated during March 2020 in response to government-mandated COVID-19 quarantines in Columbia (see Campo-Arias et al 2020 in the references section)
Measured: Baseline through 12 months post-enrollment
Type 2 Diabetes Mellitus Related Stress
Diabetes-related stress will be measured using the validated 20-item Problem Areas in Diabetes Survey (PAID) questionnaire. Each item is scored from 0 (not a problem) to 4 (serious problem). The sum of all item scores multiplied by 1.25 gives the total PAID score.
Scores range from 0 to 100, higher scores reflecting greater emotional distress.
Measured: Baseline through 12 months post-enrollment
Health-related quality of life (adult participants only)
Index participants and adult household members will receive the Short Form-8 (SF-8) questionnaire. SF-8 is an 8-item instrument that measures general aspects of health-related quality of life. Each item covers a different domain: overall health, physical functioning, role physical (difficulties with daily work because of physical pain), bodily pain, vitality, social functioning, mental health, and role emotional (absence from daily activities because of emotional problems).
Items are assessed individual 5- or 6-point Likert scales, a higher score on each question indicates poorer quality of life in that domain.
Measured: Baseline through 12 months post-enrollment
Health-related quality of life (adolescent household members only)
Instead of the SF-8 (see previous outcome), adolescent household members will receive the Kid-Screen-10, a questionnaire is designed for children ages 8-18 to assess subjective health and psychological, mental, and social well-being.
Scores range from 10 to 50, with higher scores indicating higher health-related quality of life.
Measured: Baseline through 12 months post-enrollment
Depression
Possible depression will be measured using the Patient Health Questionnaire (PHQ-8), which measures 8 criteria from the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders). Each criteria is scored from "0" (not at all) to "3" (nearly every day). Range is 0-24, higher total score indicates more severe depression.
Measured: Baseline through 12 months post-enrollment
Depression (index participant only)
For index participants, depression will be measured using the Patient Health Questionnaire (PHQ-9), which measures 8 criteria from the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) and a ninth question on suicidal thoughts. Each criteria is scored from "0" (not at all) to "3" (nearly every day). Range is 0-27, higher total score indicates more severe depression.
Measured: Baseline through 12 months post-enrollment
Anxiety
Level of anxiety will be measured using the General Anxiety Disorder-7 (GAD-7). This is a 7 item instrument that uses some of the DSM-V (Diagnostic and Statistical Manual of Mental Disorders) criteria for General Anxiety Disorder along with measuring anxiety symptom severity. Scores range from 0 to 21, higher scores indicate more severe anxiety.
Measured: Baseline through 12 months post-enrollment
Self-reported Loneliness
The validated UCLA 3 item Loneliness Scale will be used. The scale is designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as "hardly ever" (1), "some of the time" (2), or "often" (3).
Scores range from 3 to 9, higher scores indicate greater levels of loneliness.
Measured: Baseline through 12 months post-enrollment
Dietary Intake Over 24 Hour Period (index participants only)
Index participants will complete three 24-hour diet recalls using the Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool. The module includes multiple-pass methodology to capture all foods eaten in the previous 24 hours. A researcher will administer the tool to reduce respondent burden. Output for 24-hour diet recall is extensive, but will include our key dietary outcomes for daily (averaged) intakes of: total vegetables, dark green vegetables, beans/legumes, and whole grains.
Scores:
Healthy Eating Index (HEI): 0 to 100, higher indicates greater alignment with healthy dietary guidelines Fruit \& vegetable: 0-20 servings/day, higher scores preferred Total calorie intake: 1000-6000 kcal/day Total fat: 0-400 g/day
Interview method adapted from Conway et al 2004 (see references section).
Measured: Baseline through 12 months post-enrollment
Dietary Intake (household members only)
Household members will be given the 10-item Dietary Screener Questionnaire (DSQ-10). The questionnaire will capture consumption of fruit/vegetables, fiber, whole grains, and added sugars. Scores range from 0 to 100, higher scores indicate more frequent consumption of healthy foods.
They will also be asked additional questions about whole grain foods, which will be scored the same way. These will be based on the dietary screener developed by Thompson and colleagues (see Thompson et al 2017 in references section).
Measured: Baseline through 12 months post-enrollment
Diet-Related Behaviors: Food Preferences & Consumption
We will create a multi-part questionnaire to assess diet-related behaviors:
- Self-efficacy to eat fruits/vegetables will be measured using selected items from the National Cancer Institute's Food Attitudes and Behaviors Survey. Scores range from 7 to 35, higher score indicates greater self-efficacy/confidence in ability to consume fresh fruits and veg.
- To assess food preferences, participants will be asked Likert-style questions about specific vegetables and whole grains. Higher score indicates stronger "liking".
- To assess healthy food consumption, participants will be asked a series of questions about whether they ate specific whole grain foods in the past 7 days. Higher score indicates more frequent consumption.
- There will also be three questions specifically about participants use of brown rice (regular and instant). Individual answers will be compared across time points.
Measured: Baseline through 12 months post-enrollment
Changes in Diet-Related Behaviors
Participants will be asked a series of questions designed by the research team to examine changes in their whole grain and vegetable consumption over the past 6 months. Higher score is generally a better outcome as it indicates increase in consumption of these healthy foods.
Measured: 6 months through 12 months post-enrollment
Change in physical activity
Using the 7-day Physical Activity Recall, each participant will complete a semi-structured interview that estimates their time spent doing physical and sleep activities in the past 7 days.
Scores are:
- Leisure time moderate and vigorous physical activity, ranging from 0-1500 min/week, higher scores preferred
- Total energy expenditure, ranging from 06-60 kcal per kg per day, lower scores preferred.
Measured: Baseline through 12 months post-enrollment
Food Neophobia Scale (FNS)
Comprises 10 items to which responses are given on a seven-point Likert scale ranging from "strongly disagree" to "strongly agree."
Score ranges from 10 to 70, a higher total score indicates greater food neophobia level and lower tendency to try unfamiliar foods.
Measured: Baseline through 12 months post-enrollment
Control Over Food Choices
Participants will be asked a three part-questionnaire about control and food choices in the past 6 months:
- Nutrition security is measured with 4 items about food choice availability. Answers are never, rarely, sometimes, often, or always; higher rankings indicates greater nutrition insecurity. Scores range 0-16.
- Healthfulness Control is measured with 2 items about sense of control over what they ate or served to their families. Answers are never, rarely, sometimes, often, or always; higher rankings indicates greater control. Scores range 0-8.
- Utilization barriers are measured with 2 items about whether participants are able to select healthy foods and make healthy meals. Each item is ranked never true, sometimes true, often true; higher ranking indicates greater utilization barrier. Scores range 0-8.
Measured: Baseline through 12 months post-enrollment
Nutrition Security Screener
The Nutrition Security Screener (NSS) was developed by Tufts University, Kaiser Permanente, and Los Angeles Department of Public Health. The questionnaire contains 14 questions, divided into two sections:
- "How hard was it for you or your household to regularly get and eat healthy foods?" Answers are "very hard" (0) , "hard" (1), "somewhat hard"(2) "not very hard" (3) and "not hard at all." (4).
- Participants are asked rate 13 different barriers to being able to eat or prepare healthy meals. Each item is ranked "very little or not at all", "somewhat" or "a great deal."
Question 1 will be scored on a scale of 1-4 to indicate if food security is very low, low, marginal, or secure. Measure designers have not validated a scale for question 2, so it will be analyzed descriptively.
Measured: Baseline through 12 months post-enrollment
Interest in Community Supported Agriculture (CSA) Programs
Community Supported Agriculture (CSA) is a local farm-to-table model where customers can sign up for a subscription with a local farm and receive a weekly box of seasonal fruits and vegetables.
Participants will be asked a 4 item questionnaire to gauge their experiences with, and interest in, such food boxes, including how much they would be willing to spend for one (e.g. $10-20 per bag). There is no scoring rubric, results are descriptive.
Measured: Baseline through 12 months post-enrollment
Household Food Insecurity
Each participant will complete the USDA's U.S. Household Food Security Survey Module: Six-Item Short Form to measure household food security.
Raw scores are converted into food security status as follows: 0-1 indicates high or marginal food security, 2-4 indicates low food security, and 5-6 indicates very low food security.
Measured: Baseline through 12 months post-enrollment
Food Assistance Programs
Participants are asked whether their household currently receives (or has received in the past 6 months) various sorts of food assistance, such as:
- Women, Infants and Children Program (WIC)
- government food assistance programs known as CalFresh, SNAP (Supplemental Nutrition Assistance Program), EBT (Electronic Benefits Transfer), or food stamps
- other sources of free food within the last 6 months such as church, food pantry / food bank, soup kitchen, etc, including an open-ended question
There is no scoring rubric, results are descriptive.
Measured: Baseline through 12 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start18 Sep 2023
- Primary completion10 Aug 2026
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to receive household food deliveries and intensive lifestyle intervention OR to a waitlist control group who only receives the household food deliveries (after a 6 month wait). Both groups will be followed for 12 months. Both groups will continue usual primary care for their diabetes.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- La Clínica de La Raza Inc., National Institutes of Health (NIH), Dig Deep Farms, Yeyi Organics, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Lisa Goldman Rosas, Stanford University
- Investigators
- Lisa Goldman Rosas, PhD, MPH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228860
- Sponsor's protocol ID
- 62283
- Other IDs
- 1R01MD016738-01
- Acronym
- ADELANTE
- Status last verified
- Sep 2026
- First submitted
- 27 Jan 2022
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ellison B, McFadden B, Rickard BJ, Wilson N. Examining food purchase behavior and food values during the COVID-19 pandemic. Applied Economic Perspectives and Policy. 2021;43(1):58-72. http://dx.doi.org/10.1002/aepp.13118
Blair SN, Haskell WL, Ho P, Paffenbarger RS Jr, Vranizan KM, Farquhar JW, Wood PD. Assessment of habitual physical activity by a seven-day recall in a community survey and controlled experiments. Am J Epidemiol. 1985 Nov;122(5):794-804. doi: 10.1093/oxfordjournals.aje.a114163.
PubMed 3876763Zuazagoitia A, Montoya I, Grandes G, Arietaleanizbeascoa MS, Arce V, Martinez V, Sanchez M, Sanchez A. Reliability and validity of the 7-day Physical Activity Recall interview in a Spanish population. Eur J Sport Sci. 2014;14 Suppl 1:S361-8. doi: 10.1080/17461391.2012.705332. Epub 2012 Jul 25.
PubMed 24444230Sarkar U, Schillinger D, Lopez A, Sudore R. Validation of self-reported health literacy questions among diverse English and Spanish-speaking populations. J Gen Intern Med. 2011 Mar;26(3):265-71. doi: 10.1007/s11606-010-1552-1. Epub 2010 Nov 6.
PubMed 21057882Marin G, Gamba RJ. A new measurement of acculturation for Hispanics: The Bidimensional Acculturation Scale for Hispanics (BAS). Hispanic Journal of Behavioral Sciences. 1996;18(3):297-316. http://dx.doi.org/10.1177/07399863960183002
Domel SB, Baranowski T, Davis H, Leonard SB, Riley P, Baranowski J. Measuring fruit and vegetable preferences among 4th- and 5th-grade students. Prev Med. 1993 Nov;22(6):866-79. doi: 10.1006/pmed.1993.1078.
PubMed 8115344Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.
PubMed 3432232Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20-40. doi: 10.1207/s15327752jpa6601_2.
PubMed 8576833Conway JM, Ingwersen LA, Moshfegh AJ. Accuracy of dietary recall using the USDA five-step multiple-pass method in men: an observational validation study. J Am Diet Assoc. 2004 Apr;104(4):595-603. doi: 10.1016/j.jada.2004.01.007.
PubMed 15054345Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE. Assessment of diabetes-related distress. Diabetes Care. 1995 Jun;18(6):754-60. doi: 10.2337/diacare.18.6.754.
PubMed 7555499Thompson FE, Midthune D, Kahle L, Dodd KW. Development and Evaluation of the National Cancer Institute's Dietary Screener Questionnaire Scoring Algorithms. J Nutr. 2017 Jun;147(6):1226-1233. doi: 10.3945/jn.116.246058. Epub 2017 May 10.
PubMed 28490673Calloway EE, Carpenter LR, Gargano T, Sharp JL, Yaroch AL. Development of new measures to assess household nutrition security, and choice in dietary characteristics. Appetite. 2022 Dec 1;179:106288. doi: 10.1016/j.appet.2022.106288. Epub 2022 Aug 29.
PubMed 36049571Campo-Arias A, Pedrozo-Cortes MJ, Pedrozo-Pupo JC. Pandemic-Related Perceived Stress Scale of COVID-19: An exploration of online psychometric performance. Rev Colomb Psiquiatr (Engl Ed). 2020 Oct-Dec;49(4):229-230. doi: 10.1016/j.rcp.2020.05.005. Epub 2020 Jul 17. No abstract available.
PubMed 33328014Radtke MD, Chen WT, Xiao L, Rodriguez Espinosa P, Orizaga M, Thomas T, Venditti E, Yaroch AL, Zepada K, Rosas LG, Tester J. Addressing diabetes by elevating access to nutrition (ADELANTE) - A multi-level approach for improving household food insecurity and glycemic control among Latinos with diabetes: A randomized controlled trial. Contemp Clin Trials. 2024 Nov;146:107699. doi: 10.1016/j.cct.2024.107699. Epub 2024 Sep 23.
PubMed 39322114
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Diabetes by Elevating Access to Nutrition: The ADELANTE Study
- ClinicalTrials.gov ID
- NCT05228860
- Acronym / sponsor ID
- ADELANTE / 62283
- Conditions
- Diabetes, Obesity, Lifestyle, Healthy
- Keywords
- food insecurity, community health worker, health coach, weight loss, HbA1c, T2DM, glycemic control, multilevel
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- La Clínica de La Raza Inc., National Institutes of Health (NIH), Dig Deep Farms, Yeyi Organics, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- Sep 2027 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of ADELANTE is to determine whether a multi-level intervention to improve household food insecurity and glycemic control is effective for Latino patients with diabetes.
Specifically, ADELANTE aims to
- determine whether weekly household food delivery plus an intensive lifestyle intervention is more effective than usual care for improving glycemic control (HbA1c) at 6 months,
- examine the effects of the multi-level intervention on = household food insecurity, dietary behaviors, and psychosocial outcomes, and
- assess the future potential for implementation and dissemination of this multi-level intervention in primary care settings.
Detailed description
Participants and up to two of their household members will be randomized to one of two groups:
- healthy food box home delivery for 12 weeks plus a 12-month remotely delivered lifestyle behavioral intervention, Vida Sana, which incorporates family members and is aligned with Latino cultural values, or
- a wait list control group who will receive the food box deliveries 6 months later (but not the Vida Sana intervention).
The first 6 months will evaluate the effects of receiving Vida Sana plus food delivery versus being randomized to control (no intervention); the final 6 months will evaluate receiving food delivery with versus without Vida Sana.
VIDA SANA (intervention arm):
The Vida Sana intervention is a cultural adaptation of Group Lifestyle Balance, a 12-month group program in turn adapted from the NIH/NIDDK-supported Diabetes Prevention Program (DPP). It has been shown to be effective in promoting clinically significant, modest weight loss and significant improvements in moderate-intensity physical activity. Participants receive a total of 23 group sessions over 12 months with a trained health coach who provides personalized feedback based on self-tracking.
The program emphasizes a) moderate caloric reduction by 500-1,000 calories per day through healthy substitutions, b) incremental increases in moderate physical activity such as brisk walking, and c) behavioral strategies to support successful adoption and maintenance of healthy behaviors. These behavioral strategies include realistic goal setting, fostering social support, and stress management. Study health coaches will also add COVID-specific topics to ensure that participants are equipped to change behavior and manage stress during the pandemic.
FOOD BOXES (intervention arm (immediately) and control arm (6 months later)):
Each healthy food box delivery will include a variety of seasonal produce and a rotation of different whole grain foods (3+ grams of fiber/serving) such as cereal, pasta, tortillas, bread, and crackers. Participants will receive familiar foods as well as (intentionally) unfamiliar items to encourage them to try new foods. All items are also available at low-cost grocery stores so participants can continue to purchase them after the end of the study if they wish. The quantity is scaled to three household sizes. It is intended to supplement a family's food supply and provide opportunities for trying new fiber-rich foods recommended by the Vida Sana intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to receive household food deliveries and intensive lifestyle intervention OR to a waitlist control group who only receives the household food deliveries (after a 6 month wait). Both groups will be followed for 12 months. Both groups will continue usual primary care for their diabetes.
| Arm | Type | Receives |
|---|---|---|
| Food and Lifestyle Intervention Group | Experimental | Behavioral: Vida Sana (a Group Lifestyle Intervention), Behavioral: Supplemental Healthy Food DeliveriesThe 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. |
| Waitlist Control Group | Experimental | Behavioral: Supplemental Healthy Food DeliveriesThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- For main study (index/intervention) participants:
- For household members:
- For all participants:
Key exclusion criteria (6 listed)
- Unable to provide informed consent
- Unable to speak, read, or understand English and/or Spanish
- Active substance use or psychotic disorders that would impair participation in a group lifestyle intervention or interfere with follow-up assessments
- Lacking mailing address for delivery of food box
- Planning to relocate out of area within the next 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vida Sana (a Group Lifestyle Intervention)Vida Sana is a Group Lifestyle intervention that has been shown to be effective among patients with type 2 diabetes (T2DM). Vida Sana includes 23 group sessions with a trained health coach: * Months 1-4: 1 family-wide orientation + 12 weekly sessions * Months 5-6: 4 bimonthly group sessions * Months 7-12: 6 monthly group sessions All regular primary care and diabetes care will remain as usual. | Behavioural | Food and Lifestyle Intervention Group |
| Supplemental Healthy Food DeliveriesParticipants will receive 12 weeks of weekly food deliveries from Dig Deep Farms. Each delivery will include a selection of seasonal fresh vegetables and a rotation of either a whole grain or a whole-grain food (3+ grams of fiber/serving). Whole grains will include brown rice, oatmeal, barley, quinoa; whole grain foods will include cereal, pasta, tortillas, bread, crackers. Delivery sizes will be scaled to the three corresponding household sizes: 2-3 people; 4-5 people; or 6 or more people. Food will be delivered by Dig Deep Farms, which already has an established food subscription delivery system. (Control group participants will receive the same delivery schedule, but delayed to begin 6 months after their study enrollment.) | Behavioural | Food and Lifestyle Intervention Group, Waitlist Control Group |
Primary outcome
HgbA1c
Time frame: Baseline through 12 months post-enrollment
Study staff will gather fingerstick blood samples for HgbA1c.
23 secondary outcomes
nonHDL Cholesterol
Time frame: Baseline through 12 months post-enrollment
Blood Pressure
Time frame: Baseline through 12 months post-enrollment
Change in Body Mass Index (BMI)
Time frame: Baseline through 12 months post-enrollment
Change in waist-height ratio
Time frame: Baseline through 12 months post-enrollment
Pandemic-Related Perceived Stress Scale of COVID-19 (PSS-10-C)
Time frame: Baseline through 12 months post-enrollment
Type 2 Diabetes Mellitus Related Stress
Time frame: Baseline through 12 months post-enrollment
Health-related quality of life (adult participants only)
Time frame: Baseline through 12 months post-enrollment
Health-related quality of life (adolescent household members only)
Time frame: Baseline through 12 months post-enrollment
Depression
Time frame: Baseline through 12 months post-enrollment
Depression (index participant only)
Time frame: Baseline through 12 months post-enrollment
Anxiety
Time frame: Baseline through 12 months post-enrollment
Self-reported Loneliness
Time frame: Baseline through 12 months post-enrollment
Dietary Intake Over 24 Hour Period (index participants only)
Time frame: Baseline through 12 months post-enrollment
Dietary Intake (household members only)
Time frame: Baseline through 12 months post-enrollment
Diet-Related Behaviors: Food Preferences & Consumption
Time frame: Baseline through 12 months post-enrollment
Changes in Diet-Related Behaviors
Time frame: 6 months through 12 months post-enrollment
Change in physical activity
Time frame: Baseline through 12 months post-enrollment
Food Neophobia Scale (FNS)
Time frame: Baseline through 12 months post-enrollment
Control Over Food Choices
Time frame: Baseline through 12 months post-enrollment
Nutrition Security Screener
Time frame: Baseline through 12 months post-enrollment
Interest in Community Supported Agriculture (CSA) Programs
Time frame: Baseline through 12 months post-enrollment
Household Food Insecurity
Time frame: Baseline through 12 months post-enrollment
Food Assistance Programs
Time frame: Baseline through 12 months post-enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- BackgroundEllison B, McFadden B, Rickard BJ, Wilson N. Examining food purchase behavior and food values during the COVID-19 pandemic. Applied Economic Perspectives and Policy. 2021;43(1):58-72. http://dx.doi.org/10.1002/aepp.13118
- Background: PubMed 3876763Blair SN, Haskell WL, Ho P, Paffenbarger RS Jr, Vranizan KM, Farquhar JW, Wood PD. Assessment of habitual physical activity by a seven-day recall in a community survey and controlled experiments. Am J Epidemiol. 1985 Nov;122(5):794-804. doi: 10.1093/oxfordjournals.aje.a114163.
- Background: PubMed 24444230Zuazagoitia A, Montoya I, Grandes G, Arietaleanizbeascoa MS, Arce V, Martinez V, Sanchez M, Sanchez A. Reliability and validity of the 7-day Physical Activity Recall interview in a Spanish population. Eur J Sport Sci. 2014;14 Suppl 1:S361-8. doi: 10.1080/17461391.2012.705332. Epub 2012 Jul 25.
- Background: PubMed 21057882Sarkar U, Schillinger D, Lopez A, Sudore R. Validation of self-reported health literacy questions among diverse English and Spanish-speaking populations. J Gen Intern Med. 2011 Mar;26(3):265-71. doi: 10.1007/s11606-010-1552-1. Epub 2010 Nov 6.
- BackgroundMarin G, Gamba RJ. A new measurement of acculturation for Hispanics: The Bidimensional Acculturation Scale for Hispanics (BAS). Hispanic Journal of Behavioral Sciences. 1996;18(3):297-316. http://dx.doi.org/10.1177/07399863960183002
- Background: PubMed 8115344Domel SB, Baranowski T, Davis H, Leonard SB, Riley P, Baranowski J. Measuring fruit and vegetable preferences among 4th- and 5th-grade students. Prev Med. 1993 Nov;22(6):866-79. doi: 10.1006/pmed.1993.1078.
- Background: PubMed 3432232Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.
- Background: PubMed 8576833Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20-40. doi: 10.1207/s15327752jpa6601_2.
- Background: PubMed 15054345Conway JM, Ingwersen LA, Moshfegh AJ. Accuracy of dietary recall using the USDA five-step multiple-pass method in men: an observational validation study. J Am Diet Assoc. 2004 Apr;104(4):595-603. doi: 10.1016/j.jada.2004.01.007.
- Background: PubMed 7555499Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE. Assessment of diabetes-related distress. Diabetes Care. 1995 Jun;18(6):754-60. doi: 10.2337/diacare.18.6.754.
- Background: PubMed 28490673Thompson FE, Midthune D, Kahle L, Dodd KW. Development and Evaluation of the National Cancer Institute's Dietary Screener Questionnaire Scoring Algorithms. J Nutr. 2017 Jun;147(6):1226-1233. doi: 10.3945/jn.116.246058. Epub 2017 May 10.
- Background: PubMed 36049571Calloway EE, Carpenter LR, Gargano T, Sharp JL, Yaroch AL. Development of new measures to assess household nutrition security, and choice in dietary characteristics. Appetite. 2022 Dec 1;179:106288. doi: 10.1016/j.appet.2022.106288. Epub 2022 Aug 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Goldman Rosas, PhD, MPH principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vida Sana (a Group Lifestyle Intervention) and Supplemental Healthy Food Deliveries in people with Diabetes and Obesity, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HgbA1c (time frame: Baseline through 12 months post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05228860, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.