Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
360 participants
INTERVENTIONAL
2023-09-18
2027-09-30
Brief Summary
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Specifically, ADELANTE aims to
1. 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,
2. examine the effects of the multi-level intervention on = household food insecurity, dietary behaviors, and psychosocial outcomes, and
3. assess the future potential for implementation and dissemination of this multi-level intervention in primary care settings.
Detailed Description
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1. 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
2. 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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Food and Lifestyle Intervention Group
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 (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.
Supplemental Healthy Food Deliveries
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.)
Waitlist Control Group
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.
Supplemental Healthy Food Deliveries
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.)
Interventions
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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.
Supplemental Healthy Food Deliveries
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.)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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La Clínica de La Raza Inc.
OTHER
National Institutes of Health (NIH)
NIH
Dig Deep Farms
UNKNOWN
Yeyi Organics
UNKNOWN
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Stanford University
OTHER
Responsible Party
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Lisa Goldman Rosas
Principal Investigator, Assistant Professor, Department of Health Research and Policy (Epidemiology) and Medicine (Primary Care and Population Health) Faculty Director, Office of Community Engagement Stanford School of Medicine
Principal Investigators
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Lisa Goldman Rosas, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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La Clínica Monument
Concord, California, United States
Countries
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Central Contacts
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References
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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.
Zuazagoitia 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.
Sarkar 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.
Marin 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.
Sallis 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.
Russell 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.
Conway 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.
Polonsky 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.
Thompson 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.
Calloway 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.
Campo-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.
Radtke 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.
Other Identifiers
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62283
Identifier Type: -
Identifier Source: org_study_id