Diabetes, Nutrition
Conditions
Keywords
Type 2 Diabetes, Diabetes, Nutrition, Vegetables, Fruits
Brief summary
The aim of this proposal is to determine the impact of a produce prescription program in predominantly Hispanic/Latino adults with established non-insulin treated T2D and an HbA1c at or above 9%.
Detailed description
The aim of this proposal is to determine the impact of a produce prescription program in predominantly Hispanic/Latino adults with established non-insulin treated T2D and an HbA1c at or above 9%. For individuals not responding to the produce prescription program, they will be randomized to the addition of real-time continuous glucose monitoring (rtCGM) or continue with the produce prescription program only for a further 3 months.
Interventions
DEVICECGM Device
Fruits and Vegetables and some groups will get CGM devices along with Fruits and Vegetables
Sponsors
William Marsh Rice University
Sutter Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
Adults (aged\>18 years) with established T2D and HbA1c of 9% or higher per most recent test result within the last 6 months. Agreement to only track glucose levels via study-provided CGM -
Exclusion criteria
Type 1 diabetes, Insulin use, Pregnancy, Use of steroids or medications that impact glucose levels Medications Include: Atypical antipsychotics Clozapine Olanzapine Paliperidone Quietiapine Risperidone Corticosteroids Calcineurin inhibitors Cyclosporine Sirolimus Tacrolimus Protease Inhibitors Atazanavir Darunavir Fosamprenavir Indinavir Nelfinavir Ritonivir Saquinavir Tipranivir Life expectancy less than 6 months Diagnosis of stage 5 kidney disease or at risk of needing dialysis per Investigator discretion Any active clinically significant disease or disorder which in the investigator's opinion could interfere with participation in the study. Inability to follow study procedures per Investigator discretion \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c at 18 weeks compared to baseline | 18 weeks | Change in HbA1c at 18 weeks compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | 6 weeks and 3 months | Weight will be measured in kg. |
| Waist Circumference | 6 weeks and 3 months | Waist Circumference will be measure in cm |
| Blood Pressure | 6 weeks and 3 months | Blood pressure will be measure in mm Hg. |
| Depression and anxiety are measured using DASS-21 (Depression Anxiety Stress Scale - 21) | 6 weeks and 3 months | For the scales, the DASS-21 (Depression Anxiety Stress Scale - 21) reports on depression, anxiety, and stress by using a self-report questionnaire with 21 items. It consists of three subscales, each with seven items, assessing the frequency and severity of symptoms related to each emotion. The questionnaire uses a Likert scale (0-3) where higher scores indicate greater symptom severity. Scoring: Each subscale (Depression, Anxiety, and Stress) is scored separately by summing the responses to its respective items. The total score for each subscale can range from 0 to 21. Interpretation: Higher scores on each subscale indicate a higher level of the corresponding variable. |
| Height | 6 weeks and 3 months. | Height will be measure in inches. |
Countries
United States
Contacts
Primary ContactDavid Kerr, PhD
Backup ContactBrett Avery
Outcome results
None listed