Recruiting

Nutritional Access

Sponsor:

Stanford University

Code:

NCT05228860

Conditions

Diabetes

Obesity

Lifestyle, Healthy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vida Sana (a Group Lifestyle Intervention)

Supplemental Healthy Food Deliveries

Study Details

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.

Conditions

Diabetes

Obesity

Lifestyle, Healthy

Study ID

NCT05228860

Start date

Sep 18, 2023

Status verified date

Nov, 2024

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

Interventions

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.)

Primary outcome measure

  • HgbA1c [ Time Frame: Baseline through 12 months post-enrollment ]

Central Contacts and Locations

Central contacts

Study Coordinator

650-725-5180morizaga@stanford.edu

Locations

La Clínica Monument

Recruiting

Concord, California, United States, 94518

More Information

Sponsor

Stanford University

Last update posted

Dec 2, 2024

Last verified

Nov, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2024-12-02.