Addressing Diabetes by Elevating Access to Nutrition

NCT05228860 | Recruiting

• 2 other identifiers: 622831R01MD016738-01
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.examine the effects of the multi-level intervention on = household food insecurity, dietary behaviors, and psychosocial outcomes, and
3. 3.assess the future potential for implementation and dissemination of this multi-level intervention in primary care settings.

Conditions

Diabetes; Obesity; Lifestyle, Healthy

Keywords

food insecurity; community health worker; health coach; weight loss; HbA1c; T2DM; glycemic control; multilevel

Outcome Measures

Primary Outcomes (1)

• HgbA1c

  Study staff will gather fingerstick blood samples for HgbA1c.

  Baseline through 12 months post-enrollment

Secondary Outcomes (23)

• nonHDL Cholesterol

  Baseline through 12 months post-enrollment

• Blood Pressure

  Baseline through 12 months post-enrollment

• Change in Body Mass Index (BMI)

  Baseline through 12 months post-enrollment

• Change in waist-height ratio

  Baseline through 12 months post-enrollment

• Pandemic-Related Perceived Stress Scale of COVID-19 (PSS-10-C)

  Baseline through 12 months post-enrollment

Study Arms (2)

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.

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.

Behavioral: Supplemental Healthy Food Deliveries

Interventions

Vida Sana (a Group Lifestyle Intervention) BEHAVIORAL

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.

Food and Lifestyle Intervention Group

Supplemental Healthy Food Deliveries BEHAVIORAL

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.)

Food and Lifestyle Intervention Group; Waitlist Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• La Clínica de La Raza Inc.: collaborator
• National Institutes of Health (NIH): collaborator
• Dig Deep Farms: collaborator
• Yeyi Organics: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

La Clínica Monument

Concord, California, 94518, United States

RECRUITING

Related Publications (14)

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 15054345 BACKGROUND

• 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.

  PMID: 7555499 BACKGROUND

• 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.

  PMID: 28490673 BACKGROUND

• 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.

  PMID: 36049571 BACKGROUND

• 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.

  PMID: 33328014 BACKGROUND

• 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.

  PMID: 39322114 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Lisa Goldman Rosas, PhD, MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

650-725-5180; morizaga@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will know which group they have been randomized to. The investigator and statistician will not know to which group a participant belongs. Group identifiers will be removed prior to analysis.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 8, 2022
• Study Start: September 18, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)