Testing and Monitoring of Blood Glucose Levels
OtherPoint-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals
NCT Number: NCT02569060
The Feeding America Intervention Trial for Health-Diabetes Mellitus (FAITH-DM) is a randomized, controlled study of the implementation of a diabetes intervention in food pantry settings.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Alameda County Community Food Bank, Oakland, California, United States
For adults with diabetes mellitus, diabetes self-management education (DSME) is critical to achieving long-term control of blood sugar levels (glycemic control) and preventing diabetes-associated complications. This education is often difficult to access for highly vulnerable and marginalized adults in the United States. Furthermore, foods for a diabetic diet are often out of reach for food insecure households. The purpose of this study is to determine the extent to which food banks and food pantries can help reach this population with effective DSME, food, and access to primary health care. The investigators' primary outcome of interest is HbA1c improvement in the intervention group compared to a wait-listed control group of food pantry clients living with uncontrolled type 2 diabetes.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals
Referral to a local primary care provider, if none currently exists. Coordination of care with primary care provider.
Food (perishable and non-perishable) appropriate for diabetes self-management available for pick-up at the food pantry twice monthly.
Education materials drawn from evidence-based practice and adapted from existing diabetes education curricula to be flexible to individual, community, and site variations. The Immediate Intervention Arm receives more robust diabetes self-management education (with group education visits) than the Waitlist Control Arm.
Time frame: 6 months
Point-of-care HbA1c testing with the PTS Diagnostics A1CNow®+ System
Time frame: 6 months and 12 months
Brief fruit & vegetable dietary screener
Time frame: 6 months and 12 months
Communication with primary care provider requesting dates of service, service levels, and diagnosis codes
Time frame: 6 months and 12 months
Self-reported distress as assessed by the 2-item emotional burden sub-score of the Diabetes Distress Scale
Time frame: 6 months and 12 months
Self-reported hypoglycemic events over the previous 4 weeks, both any events and number of events, and self-reported severe hypoglycemic episodes, both any events and number of events
Time frame: 6 months and 12 months
PHQ-8 (a subset of PHQ-9 scores without assessment of suicidality)
Time frame: 6 months and 12 months
Morisky Medication Adherence Scale (4 items)
Time frame: 6 months and 12 months
Three self-reported questions
Time frame: 6 months and 12 months
6-item version of the USDA's Core Food Security Survey Module
Time frame: 6 months and 12 months
Two items assessing adequacy of food resources to last the entire month
Time frame: 6 months and 12 months
8-item scale of diabetes-specific self-efficacy
Time frame: 6 months and 12 months
Self-reported assessment of 5 self-care behaviors: medications, exercise, diet, blood sugar monitoring, and foot care
University of California, San Francisco
Other
Acronym: FAITH-DM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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