Dietary HabitsCHATNCT05293340
Continuous Glucose Monitoring and Hass Avocado Trial ("CHAT")
A study testing Avocado Vouchers in people with Dietary Habits and Diabetes Mellitus, Type 2, run by Sansum Diabetes Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dietary Habits, Diabetes Mellitus, Type 2
- What is being tested?
- Avocado Vouchers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2022to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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].
Who cannot join
- Use of insulin
- Pregnancy
- Any active clinically significant disease or disorder which in the investigator's opinion could interfere with participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
Official title: Avocado Voucher Impact on Health Outcomes in Hispanic/Latino Adults With or At-risk of Type 2 Diabetes
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.
Read the 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).
- Conditions
- Dietary Habits, Diabetes Mellitus, Type 2
- Being tested
- Avocado Vouchers
- Keywords
- Glycemic control, Minority Health, Plants, Edible, Food prescriptions, Food security, Time in Range
- Medical subject headings
- Feeding Behavior, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avocado VouchersDietary supplement
Food as Medicine to demonstrate clinically meaningful benefits for underserved communities. Avocados are fruits with fats, fiber, micronutrients, and bioactive phytochemicals.
| Study group | Role | What they receive |
|---|---|---|
| Hispanic/Latino adults with or at risk of T2D- Active Group | Experimental | Eligible participants receive vouchers for free avocados. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Changes in waist circumference
Measured: At Enrollment Visit and at 14 weeks from Enrollment Visit
Blood Pressure- Diastolic and Systolic- Change from Enrollment Visit to Study Conclusion Visit
Changes in blood pressure
Measured: At Enrollment visit and at 14 weeks from Enrollment Visit
HbA1c- Change from Enrollment Visit to Study Conclusion Visit
Changes in HbA1c
Measured: At Enrollment Visit and at 14 weeks from Enrollment Visit
Insulin resistance- Change from Enrollment Visit to Study Conclusion Visit
Changes in Insulin Resistance
Measured: At Enrollment visit and at 14 weeks from enrollment visit
Lipids- Change from Enrollment Visit to Study Conclusion Visit
Changes in lipids
Measured: 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
Changes in prescribed medicines for T2D and/or hypertension
Measured: 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
Changes in self-reported sleep, mood, and pain (Best to Worst)
Measured: 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
Changes in Food Security
Measured: At enrollment visit, and at 14 weeks from enrollment visit
Depression via the Depression, Anxiety and Stress Scale (DASS-21)
Change in depression score (0-42), with higher scores indicating higher levels of depression
Measured: At enrollment visit, and at 14 weeks from enrollment visit
Anxiety via the Depression, Anxiety and Stress Scale (DASS-21)
Change in anxiety score (0-42), with higher scores indicating higher levels of anxiety
Measured: At enrollment visit, and at 14 weeks from enrollment visit
Stress via the Depression, Anxiety and Stress Scale (DASS-21)
Change in stress score (0-42), with higher scores indicating higher levels of stress
Measured: At enrollment visit, and at 14 weeks from enrollment visit
Change in Eating Self-Efficacy Scale (ESES) score
Change in Eating Self-Efficacy Scale (ESES) mean score (25-175), with higher scores indicating lower eating self-efficacy.
Measured: Prior to intervention (Week 0), and during final 2 weeks of intervention (Week 13 or 14)
Change in Self-Report Habit Index (SRHI) score
Change in Self-Report Habit Index (SRHI) mean score (1-7), with higher scores indicating stronger habits.
Measured: Prior to intervention (Week 0), and during final 2 weeks of intervention (Week 13 or 14)
Change in Self-Regulation of Eating Questionnaire (SREBQ) score
Change in Self-Regulation of Eating Behaviour Questionnaire (SREBQ) mean score (1-5), with higher scores indicating better self-regulation of eating behavior.
Measured: 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
Physical Activity- Daily step count averaged over ≤14 days, Change from first Fitbit application (pre-intervention) to second Fitbit application (in final 14 days of intervention).
Measured: First Fitbit application (pre-intervention) to second Fitbit application (in final 14 days of intervention)
Sleep Duration
Change in Sleep Duration (in minutes) averaged over ≤14 days
Measured: 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
Change in TIR between 140 and 180 mg/dL [TIR (140-180)] between 6 am and 12 am (waking hours), averaged over ≤14 days from first CGM application (pre-intervention) to second CGM application (in final 14 days of intervention).
Measured: first CGM application (pre-intervention) to second CGM application (in final 14 days of intervention).
Secondary Continuous Glucose Monitoring Endpoints- Average Glucose
Change in Average Glucose averaged over ≤14 days from first CGM application (pre-intervention) to second CGM application (in final 14 days of intervention).
Measured: first CGM application (pre-intervention) to second CGM application (in final 14 days of intervention).
Secondary Continuous Glucose Monitoring Endpoints- Time in Range (TIR) 70-180 mg/dL
Change in TIR 70-180 mg/dL averaged over ≤14 days from first CGM application (pre-intervention) to second CGM application (in final 14 days of intervention).
Measured: first CGM application (pre-intervention) to second CGM application (in final 14 days of intervention).
Secondary Continuous Glucose Monitoring Endpoints- Time >180 mg/dL
Change in time >180 mg/dL averaged over ≤14 days from first CGM application (pre-intervention) to second CGM application (in final 14 days of intervention).
Measured: first CGM application (pre-intervention) to second CGM application (in final 14 days of intervention).
Secondary Continuous Glucose Monitoring Endpoints- Time <70 mg/dL
Change in time <70 mg/dL averaged over ≤14 days from first CGM application (pre-intervention) to second CGM application (in final 14 days of intervention).
Measured: first CGM application (pre-intervention) to second CGM application (in final 14 days of intervention).
Adherence to the intervention
Adherence to the intervention as measured via the daily avocado consumption log (DACL)
Measured: 12-week intervention monitoring period running weeks 2-14
Acceptability of the intervention
Acceptability of the intervention as measured by the weekly avocado acceptability questionnaire (WAAQ)
Measured: 12-week intervention monitoring period running weeks 2-14
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.
Each participant will fill out the Mini International Personality Item Tool (Mini-IPIP) at the start of the study. It comprises 20 items and assesses the five personality factors (Extraversion, Agreeableness, Conscientiousness, Neuroticism, and Imagination). Scoring includes computing the mean score for each factor with a value ranging from 1 to 5 (very inaccurate to very accurate). Avocado adherence measured as the mean of the number of avocados consumed as reported via the daily avocado consumption log (DACL) will be computed. A regression analysis will be performed between the mean of the number of avocados consumed as the response variable and the five personality factors scores as the predictor variables. The coefficients of the regression analysis will be studied to evaluate if personality traits can predict avocado adherence.
Measured: Average over 12 weeks
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)
Each participant will fill out the Food Choice Questionnaire at the start of the study. It comprises 36 items and assesses the importance of 9 types of motives underlying food selection (Health, Mood, Convenience, Sensory Appeal, Natural Content, Price, Weight Control, Familiarity and Ethical Concern). Scoring includes computing the mean score for each type of motive ranging from 1-4 with higher values indicating higher importance. Avocado adherence measured as the mean of the number of avocados consumed as reported via the daily avocado consumption log (DACL) will be computed. A regression analysis will be performed between the mean of the number of avocados consumed as the response variable and the scores of the 9 types of motives underlying food selection as the predictor variables. The coefficients of the regression analysis will be studied to evaluate if food choice motives can predict avocado adherence.
Measured: 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.
Each participant will fill out the Mini International Personality Item Tool at the start of the study. It comprises 20 items and assesses the five personality factors (Extraversion, Agreeableness, Conscientiousness, Neuroticism, and Imagination). Scoring includes computing the mean score for each factor with a value ranging from 1 to 5 (very inaccurate to very accurate). The mean of the composite acceptability score on the weekly Avocado Acceptability Questionnaire (average taken over 12 weeks) will be computed. A regression analysis will be performed between the mean of the composite acceptability score as the response variable and the five personality factors scores as the predictor variables. The coefficients of the regression analysis will be studied to evaluate if personality traits can predict acceptability score.
Measured: 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)
Each participant will fill out the Food Choice Questionnaire at the start of the study. It comprises 36 items and assesses the importance of 9 types of motives underlying food selection (Health, Mood, Convenience, Sensory Appeal, Natural Content, Price, Weight Control, Familiarity, and Ethical Concern). Scoring includes computing the mean score for each type of motive ranging from 1-4 with higher values indicating higher importance. The mean of the composite acceptability score on the weekly Avocado Acceptability Questionnaire (average taken over 12 weeks) will be computed. A regression analysis will be performed between the mean of the composite acceptability score as the response variable and the scores of the 9 types of motives underlying food selection as the predictor variables. The coefficients of the regression analysis will be studied to evaluate if food choice motives can predict acceptability score.
Measured: Average over 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start31 Mar 2022
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Why it stopped: Per discretion of Sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sansum Diabetes Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hass Avocado Board
- Responsible party
- Sponsor
- Investigators
- David Kerr, MBChB, Principal investigator, Sansum Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293340
- Sponsor's protocol ID
- C2021-0068
- Acronym
- CHAT
- Status last verified
- Nov 2023
- First submitted
- 22 Dec 2021
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avocado Voucher Impact on Health Outcomes in Hispanic/Latino Adults With or At-risk of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05293340
- Acronym / sponsor ID
- CHAT / C2021-0068
- Conditions
- Dietary Habits, Diabetes Mellitus, Type 2
- Keywords
- Glycemic control, Minority Health, Plants, Edible, Food prescriptions, Food security, Time in Range
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per discretion of Sponsor.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sansum Diabetes Research InstituteUniversity, hospital or other
- Collaborators
- Hass Avocado Board
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Hispanic/Latino adults with or at risk of T2D- Active Group | Experimental | Dietary Supplement: Avocado VouchersEligible participants receive vouchers for free avocados. |
| Hispanic/Latino adults with or at risk of T2D- Control Group | No intervention | –Eligible participants will not receive vouchers for free avocados. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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].
Key exclusion criteria (3 listed)
- Use of insulin
- Pregnancy
- Any active clinically significant disease or disorder which in the investigator's opinion could interfere with participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avocado VouchersFood as Medicine to demonstrate clinically meaningful benefits for underserved communities. Avocados are fruits with fats, fiber, micronutrients, and bioactive phytochemicals. | Dietary supplement | Hispanic/Latino adults with or at risk of T2D- Active Group |
Primary outcome
Time in range (TIR) between 140 and 180 mg/dL [TIR (140-180)]- Change from Prior to Intervention, to Final Two Weeks of Intervention
Time frame: Prior to Intervention (Week 0), and During Final 2 Weeks of Intervention (Week 13 or 14)
TIR (140 -180 mg/dL) between 6 am and 12 am (waking hours).
27 secondary outcomes
Waist Circumference- Change from Enrollment Visit to Study Conclusion Visit
Time frame: At Enrollment Visit and at 14 weeks from Enrollment Visit
Blood Pressure- Diastolic and Systolic- Change from Enrollment Visit to Study Conclusion Visit
Time frame: At Enrollment visit and at 14 weeks from Enrollment Visit
HbA1c- Change from Enrollment Visit to Study Conclusion Visit
Time frame: At Enrollment Visit and at 14 weeks from Enrollment Visit
Insulin resistance- Change from Enrollment Visit to Study Conclusion Visit
Time frame: At Enrollment visit and at 14 weeks from enrollment visit
Lipids- Change from Enrollment Visit to Study Conclusion Visit
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At enrollment visit, and at 14 weeks from enrollment visit
Depression via the Depression, Anxiety and Stress Scale (DASS-21)
Time frame: At enrollment visit, and at 14 weeks from enrollment visit
Anxiety via the Depression, Anxiety and Stress Scale (DASS-21)
Time frame: At enrollment visit, and at 14 weeks from enrollment visit
Stress via the Depression, Anxiety and Stress Scale (DASS-21)
Time frame: At enrollment visit, and at 14 weeks from enrollment visit
Change in Eating Self-Efficacy Scale (ESES) score
Time frame: Prior to intervention (Week 0), and during final 2 weeks of intervention (Week 13 or 14)
Change in Self-Report Habit Index (SRHI) score
Time frame: Prior to intervention (Week 0), and during final 2 weeks of intervention (Week 13 or 14)
Change in Self-Regulation of Eating Questionnaire (SREBQ) score
Time frame: 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
Time frame: First Fitbit application (pre-intervention) to second Fitbit application (in final 14 days of intervention)
Sleep Duration
Time frame: 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
Time frame: first CGM application (pre-intervention) to second CGM application (in final 14 days of intervention).
Secondary Continuous Glucose Monitoring Endpoints- Average Glucose
Time frame: first CGM application (pre-intervention) to second CGM application (in final 14 days of intervention).
Secondary Continuous Glucose Monitoring Endpoints- Time in Range (TIR) 70-180 mg/dL
Time frame: first CGM application (pre-intervention) to second CGM application (in final 14 days of intervention).
Secondary Continuous Glucose Monitoring Endpoints- Time >180 mg/dL
Time frame: first CGM application (pre-intervention) to second CGM application (in final 14 days of intervention).
Secondary Continuous Glucose Monitoring Endpoints- Time <70 mg/dL
Time frame: first CGM application (pre-intervention) to second CGM application (in final 14 days of intervention).
Adherence to the intervention
Time frame: 12-week intervention monitoring period running weeks 2-14
Acceptability of the intervention
Time frame: 12-week intervention monitoring period running weeks 2-14
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.
Time frame: Average over 12 weeks
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)
Time frame: 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.
Time frame: 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)
Time frame: Average over 12 weeks
Results and safety
The study was stopped early (reason given: Per discretion of Sponsor.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kerr, MBChB principal investigator
Sansum Diabetes Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avocado Vouchers in people with Dietary Habits and Diabetes Mellitus, Type 2, run by Sansum Diabetes Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Per discretion of Sponsor.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (TIR) between 140 and 180 mg/dL [TIR (140-180)]- Change from Prior to Intervention, to Final Two Weeks of Intervention (time frame: Prior to Intervention (Week 0), and During Final 2 Weeks of Intervention (Week 13 or 14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.