Addressing Diabetes by Elevating Access to Nutrition

Last updated: November 27, 2024
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetic Neuropathy

Diabetes Prevention

Treatment

Supplemental Healthy Food Deliveries

Vida Sana (a Group Lifestyle Intervention)

Clinical Study ID

NCT05228860
62283
1R01MD016738-01
  • Ages > 18
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 VitalSign questionnaire

  • Have a Body Mass Index (BMI) => 25

  • Receiving care at our partnering community health centers (e.g., Clinica de laRaza)

  • Currently residing in Alameda or Contra Costa County and not expecting torelocate in the next 6-12 months

  • Have access to phone or computer, email, and some internet for access to remoteintervention and completion of follow-up measures

  • For household members:

  • Age at enrollment: 12+ years

  • Significantly involved in supporting nutrition in the home including foodshopping, 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

Exclusion Criteria:

  • 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 agroup 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 12months

Study Design

Total Participants: 360
Treatment Group(s): 2
Primary Treatment: Supplemental Healthy Food Deliveries
Phase:
Study Start date:
September 18, 2023
Estimated Completion Date:
September 30, 2027

Study Description

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.

Connect with a study center

  • La Clínica Monument

    Concord, California 94518
    United States

    Active - Recruiting

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