Clinical trial NCT05228860: Addressing Diabetes by Elevating Access to Nutrition
Official title: Addressing Diabetes by Elevating Access to Nutrition: the ADELANTE Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Obesity
Lifestyle, Healthy
Keywords: food insecurity
community health worker
health coach
weight loss
HbA1c
T2DM
glycemic control
multilevel
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: La Clínica de La Raza Inc.
name: National Institutes of Health (NIH)
name: Dig Deep Farms
name: Yeyi Organics
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-02-08
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 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: 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.

Eligibility criteria: 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 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 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

Primary outcomes:
measure: HgbA1c
timeFrame: Baseline through 12 months post-enrollment
Secondary outcomes:
measure: nonHDL Cholesterol
timeFrame: Baseline through 12 months post-enrollment
measure: Blood Pressure
timeFrame: Baseline through 12 months post-enrollment
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline through 12 months post-enrollment
measure: Change in waist-height ratio
timeFrame: Baseline through 12 months post-enrollment
measure: Pandemic-Related Perceived Stress Scale of COVID-19 (PSS-10-C)
timeFrame: Baseline through 12 months post-enrollment
measure: Type 2 Diabetes Mellitus Related Stress
timeFrame: Baseline through 12 months post-enrollment
measure: Health-related quality of life (adult participants only)
timeFrame: Baseline through 12 months post-enrollment
measure: Health-related quality of life (adolescent household members only)
timeFrame: Baseline through 12 months post-enrollment
measure: Depression
timeFrame: Baseline through 12 months post-enrollment
measure: Depression (index participant only)
timeFrame: Baseline through 12 months post-enrollment
measure: Anxiety
timeFrame: Baseline through 12 months post-enrollment
measure: Self-reported Loneliness
timeFrame: Baseline through 12 months post-enrollment
measure: Dietary Intake Over 24 Hour Period (index participants only)
timeFrame: Baseline through 12 months post-enrollment
measure: Dietary Intake (household members only)
timeFrame: Baseline through 12 months post-enrollment
measure: Diet-Related Behaviors: Food Preferences & Consumption
timeFrame: Baseline through 12 months post-enrollment
measure: Changes in Diet-Related Behaviors
timeFrame: 6 months through 12 months post-enrollment
measure: Change in physical activity
timeFrame: Baseline through 12 months post-enrollment
measure: Food Neophobia Scale (FNS)
timeFrame: Baseline through 12 months post-enrollment
measure: Control Over Food Choices
timeFrame: Baseline through 12 months post-enrollment
measure: Nutrition Security Screener
timeFrame: Baseline through 12 months post-enrollment
measure: Interest in Community Supported Agriculture (CSA) Programs
timeFrame: Baseline through 12 months post-enrollment
measure: Household Food Insecurity
timeFrame: Baseline through 12 months post-enrollment
measure: Food Assistance Programs
timeFrame: Baseline through 12 months post-enrollment
Other outcomes:
Locations:
city: Concord
country: United States
facility: La Clínica Monument
state: California
Study officials:
affiliation: Stanford University
name: Lisa Goldman Rosas, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
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