Addressing Diabetes by Elevating Access to Nutrition

Официальное название

Addressing Diabetes by Elevating Access to Nutrition: the ADELANTE Study

Обзор

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. 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.

Подробное описание

Participants and up to two of their household members will be randomized to one of two groups:

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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. Fo

Первичные конечные точки

• HgbA1c [Срок оценки: Baseline through 12 months post-enrollment]

Вторичные конечные точки (12)

• nonHDL Cholesterol [Срок оценки: Baseline through 12 months post-enrollment]
• Blood Pressure [Срок оценки: Baseline through 12 months post-enrollment]
• Change in Body Mass Index (BMI) [Срок оценки: Baseline through 12 months post-enrollment]
• Change in waist-height ratio [Срок оценки: Baseline through 12 months post-enrollment]
• Pandemic-Related Perceived Stress Scale of COVID-19 (PSS-10-C) [Срок оценки: Baseline through 12 months post-enrollment]
• Type 2 Diabetes Mellitus Related Stress [Срок оценки: Baseline through 12 months post-enrollment]
• Health-related quality of life (adult participants only) [Срок оценки: Baseline through 12 months post-enrollment]
• Health-related quality of life (adolescent household members only) [Срок оценки: Baseline through 12 months post-enrollment]
• Depression [Срок оценки: Baseline through 12 months post-enrollment]
• Depression (index participant only) [Срок оценки: Baseline through 12 months post-enrollment]
• Anxiety [Срок оценки: Baseline through 12 months post-enrollment]
• Self-reported Loneliness [Срок оценки: Baseline through 12 months post-enrollment]

Критерии участия

Критерии включения

• 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
• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• La Clínica Monument — Concord

Публикации

• 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. PMID 3876763
• 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. PMID 24444230
• 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. PMID 21057882
• 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. PMID 8115344
• 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. PMID 3432232
• 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. PMID 8576833

Идентификаторы

NCT: NCT05228860 · 62283 · 1R01MD016738-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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