Addressing Diabetes by Elevating Access to Nutrition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Vida Sana (a Group Lifestyle Intervention)
BehavioralVida 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
BehavioralParticipants 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.)
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: Food and Lifestyle Intervention GroupExperimental treatment 2 interventions
Group B: Waitlist Control GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
HgbA1c
Study staff will gather fingerstick blood samples for HgbA1c.
Time frame
Baseline through 12 months post-enrollmentSecondary outcomes
1
nonHDL Cholesterol
Study staff will gather fingerstick blood samples for lipid measurements, focusing on non- HDL cholesterol (total minus HDL cholesterol) which is a valuable marker of atherogenic dyslipidemia in diabetic individuals that does not require a fasting state.
Time frame
Baseline through 12 months post-enrollment2
Blood Pressure
Blood pressure will be measured with an automated cuff with digital readout, or using a traditional sphygmomanometer. A study staff member will conduct the reading. Both systolic and diastolic pressure will be measured.
Time frame
Baseline through 12 months post-enrollment3
Change in Body Mass Index (BMI)
Weight (kg) and height (cm) will be measured and Body Mass Index (BMI) will be calculated in kg/m\^2. Height and weight will be gathered using standardized protocols with a portable scale and stadiometer. At baseline, these will be measured in triplicate for accuracy.
Time frame
Baseline through 12 months post-enrollment4
Change in waist-height ratio
Waist-height ratio (cm) will be calculated and compared over time. Waist circumference (cm) will be measured at iliac crest. Height (cm) will be measured using standardized protocols.
Time frame
Baseline through 12 months post-enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
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
Source ClinicalTrials.gov