Avocado Voucher Impact on Health Outcomes in Hispanic/Latino Adults With or At-risk of Type 2 Diabetes

Brief Summary

Detailed Description

In this study, continuous glucose monitoring (CGM) will be used to quantify changes in glycemic control in Hispanic/Latino adults with and at-risk of T2D before and after receiving free avocado vouchers. The impact of using CGM to determine the effect of improving access to avocados on glycemic profiles and food related-behaviors for Hispanic/Latino adults with or at risk of T2D is not known at present. To address this need, increased avocado consumption will be combined with CGM to assess post-prandial glucose responses. This is based on evidence showing that one half of a Hass avocado at lunch is associated with increased satisfaction and reduced desire to eat over the subsequent 3-5 hours in overweight or obese adults. For CGM, there is a lack of prospective data on the relationship between derived metrics and complications for adults with non-insulin treated T2D or at-risk of T2D, but glucose profiles from non-diabetic subjects suggest very tight glycemic control, with only brief postprandial excursions \>140 mg/dL. Cross-sectional data suggests more time spent between 140 and 180 mg/dl comparing predominantly Mexican American adults at risk of T2D to adults with pre-T2D and to adults with diagnosed T2D. Further, in a study examining the thresholds for CGM at which vascular disease can be detected, Lu and colleagues reported time in ranges above 140 mg/dL was associated with abnormal values for retinopathy and carotid intima-medial thickness, a measure of macrovascular disease risk. Hence, the focus in this study will be time in range between 140 and 180 mg/dl between 6 am and 12 am (waking hours).

Primary Outcomes

Secondary Outcomes

• Secondary Continuous Glucose Monitoring Endpoints- Average Glucose(first CGM application (pre-intervention) to second CGM application (in final 14 days of intervention).)
• Secondary Continuous Glucose Monitoring Endpoints- Time >180 mg/dL(first CGM application (pre-intervention) to second CGM application (in final 14 days of intervention).)
• Blood Pressure- Diastolic and Systolic- Change from Enrollment Visit to Study Conclusion Visit(At Enrollment visit and at 14 weeks from Enrollment Visit)
• Adherence to the intervention(12-week intervention monitoring period running weeks 2-14)
• Waist Circumference- Change from Enrollment Visit to Study Conclusion Visit(At Enrollment Visit and at 14 weeks from Enrollment Visit)
• Self-reported Food security via United States Dept. of Agriculture U.S. Household Food Security Survey Module: Six-Item Short Form - Change from Enrollment, and at Final Visit(At enrollment visit, and at 14 weeks from enrollment visit)
• Anxiety via the Depression, Anxiety and Stress Scale (DASS-21)(At enrollment visit, and at 14 weeks from enrollment visit)
• Stress via the Depression, Anxiety and Stress Scale (DASS-21)(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)
• Prescribed medicines for T2D and/or hypertension- Change from Enrollment Visit to Study Conclusion Visit(At enrollment visit and at 14 weeks from enrollment visit)
• Self-reported sleep, mood, and pain via 100 mm Likert scale questionnaire- Change from Enrollment, and to Final Visit(At enrollment visit, and at 14 weeks from enrollment visit)
• Change in Eating Self-Efficacy Scale (ESES) score(Prior to intervention (Week 0), and during final 2 weeks of intervention (Week 13 or 14))
• Change in Self-Report Habit Index (SRHI) score(Prior to intervention (Week 0), and during final 2 weeks of intervention (Week 13 or 14))
• Physical Activity- Daily step count, Changes from first to final Fitbit application(First Fitbit application (pre-intervention) to second Fitbit application (in final 14 days of intervention))
• Secondary Continuous Glucose Monitoring Endpoints- Time in Range (TIR) 140-180 mg/dl, Waking Hours(first CGM application (pre-intervention) to second CGM application (in final 14 days of intervention).)
• Regression analysis between avocado adherence measured as an average number of avocados consumed as reported via the daily avocado consumption log (DACL) and personality traits assessed via the Mini International Personality Item Tool.(Average over 12 weeks)
• Insulin resistance- Change from Enrollment Visit to Study Conclusion Visit(At Enrollment visit and at 14 weeks from enrollment visit)
• Depression via the Depression, Anxiety and Stress Scale (DASS-21)(At enrollment visit, and at 14 weeks from enrollment visit)
• Sleep Duration(First Fitbit application (pre-intervention) to second Fitbit application (in final 14 days of intervention))
• Secondary Continuous Glucose Monitoring Endpoints- Time in Range (TIR) 70-180 mg/dL(first CGM application (pre-intervention) to second CGM application (in final 14 days of intervention).)
• Secondary Continuous Glucose Monitoring Endpoints- Time <70 mg/dL(first CGM application (pre-intervention) to second CGM application (in final 14 days of intervention).)
• Regression analysis between the average number of avocados consumed as reported via the daily avocado consumption log (DACL) and motives underlying the selection of food assessed by the Food Choice Questionnaire (FCQ)(Average over 12 weeks)
• Regression analysis between average composite acceptability score on the weekly Avocado Acceptability Questionnaire and Personality traits assessed via the Mini International Personality Item Tool.(Average over 12 weeks)
• Regression analysis between average composite acceptability score on the weekly Avocado Acceptability Questionnaire and motives underlying the selection of food assessed by the Food Choice Questionnaire (FCQ)(Average over 12 weeks)
• Acceptability of the intervention(12-week intervention monitoring period running weeks 2-14)
• Lipids- Change from Enrollment Visit to Study Conclusion Visit(At enrollment visit and at 14 weeks from enrollment visit)
• Change in Self-Regulation of Eating Questionnaire (SREBQ) score(Prior to intervention (Week 0), and during final 2 weeks of intervention (Week 13 or 14))