NCT05293340

Brief Summary

Hispanic/Latino adults in the United States (U.S.) bear a disproportionate burden of type 2 diabetes (T2D). Dietary changes, facilitated by increased access and adherence to healthy foods, are necessary. In this study, continuous glucose monitoring (CGM) will be used to quantify changes in glycemic control in Hispanic/Latino (predominantly of Mexican origin) adults with or at-risk of T2D before and after receiving free avocados for 12 weeks. Beyond CGM-measured glycemic control, wearable activity and sleep monitors, physical exams, laboratory analyses, and questionnaires/logs will be used to track the impact of free avocado vouchers. The findings are anticipated to help clinicians provide new information to support positive behavior change to reduce the risk of T2D or progression from pre-diabetes to T2D and make it easier for patients to access healthier food, potentially leading to improved health.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

March 31, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

December 22, 2021

Last Update Submit

November 27, 2023

Conditions

Dietary HabitsDiabetes Mellitus, Type 2

Keywords

Glycemic controlMinority HealthPlants, EdibleFood prescriptionsFood securityTime in Range

Outcome Measures

Primary Outcomes (1)

  • Time in range (TIR) between 140 and 180 mg/dL [TIR (140-180)]- Change from Prior to Intervention, to Final Two Weeks of Intervention

    TIR (140 -180 mg/dL) between 6 am and 12 am (waking hours).

    Prior to Intervention (Week 0), and During Final 2 Weeks of Intervention (Week 13 or 14)

Secondary Outcomes (27)

  • Waist Circumference- Change from Enrollment Visit to Study Conclusion Visit

    At Enrollment Visit and at 14 weeks from Enrollment Visit

  • Blood Pressure- Diastolic and Systolic- Change from Enrollment Visit to Study Conclusion Visit

    At Enrollment visit and at 14 weeks from Enrollment Visit

  • HbA1c- Change from Enrollment Visit to Study Conclusion Visit

    At Enrollment Visit and at 14 weeks from Enrollment Visit

  • Insulin resistance- Change from Enrollment Visit to Study Conclusion Visit

    At Enrollment visit and at 14 weeks from enrollment visit

  • Lipids- Change from Enrollment Visit to Study Conclusion Visit

    At enrollment visit and at 14 weeks from enrollment visit

  • +22 more secondary outcomes

Study Arms (2)

Hispanic/Latino adults with or at risk of T2D- Active Group

EXPERIMENTAL

Eligible participants receive vouchers for free avocados.

Dietary Supplement: Avocado Vouchers

Hispanic/Latino adults with or at risk of T2D- Control Group

NO INTERVENTION

Eligible participants will not receive vouchers for free avocados.

Interventions

Avocado VouchersDIETARY_SUPPLEMENT

Food as Medicine to demonstrate clinically meaningful benefits for underserved communities. Avocados are fruits with fats, fiber, micronutrients, and bioactive phytochemicals.

Hispanic/Latino adults with or at risk of T2D- Active Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥ 18 years of age at enrollment.
  • Self-reported Hispanic/Latino heritage.
  • Self-reported diagnosis of T2D or self-reported as at risk for developing T2D using the American Diabetes Association diabetes risk assessment tool \[25\].

You may not qualify if:

  • Use of insulin
  • Pregnancy
  • Any active clinically significant disease or disorder which in the investigator's opinion could interfere with participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

MeSH Terms

Conditions

Feeding BehaviorDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • David Kerr, MBChB

    Sansum Diabetes Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study will consist of two groups into which participants will be randomly assigned 1:1. One (active) group will receive vouchers for free avocados. The other (control) group will not receive avocado vouchers (to control for the impact of seasonal changes on diet that are outside the influence of the trial).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2021

First Posted

March 24, 2022

Study Start

March 31, 2022

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)