Clinical trial NCT02569060: Feeding America Intervention Trial for Health--Diabetes Mellitus
Official title: Feeding America Intervention Trial for Health--Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes mellitus
community intervention
intervention
randomized
dietary intervention
self-management support
food bank
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Feeding America
name: Laura and John Arnold Foundation
name: Urban Institute
First posted: 2015-10-06
Enrollment: 568
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Food pantry client at one of three participating food banks: Alameda County Community Food Bank (Oakland, CA), Gleaners Community Food Bank of Southeastern Michigan (Detroit, MI), Houston Food Bank, (Houston, TX)
* Type II diabetes mellitus with HbA1c ≥ 7.5% using food bank point-of-care testing
* Reliable mode of contact (either phone or address)
* English or Spanish verbal fluency
* 18 years of age or older
* Intent to remain in the study area for at least the next 12 months
* Willingness to participate in intervention

Exclusion Criteria:

* Type 1 diabetes
* Pregnant or less than 6 weeks post-partum
* Cognitively impaired: dementia, mental illness, or active substance abuse severe enough to interfere with administration of the survey or participation in the intervention
* Household member already enrolled in the study

Primary outcomes:
measure: Change from Baseline HbA1c at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Change from Baseline Dietary Intake
timeFrame: 6 months and 12 months
measure: Change from Baseline Health Care Utilization
timeFrame: 6 months and 12 months
measure: Change from Baseline Diabetes Distress
timeFrame: 6 months and 12 months
measure: Change from Baseline Hypoglycemic events
timeFrame: 6 months and 12 months
measure: Change from Baseline Depressive symptoms
timeFrame: 6 months and 12 months
measure: Change from Baseline Medication Adherence
timeFrame: 6 months and 12 months
measure: Food vs medicine trade-offs
timeFrame: 6 months and 12 months
measure: Change from Baseline Food security status
timeFrame: 6 months and 12 months
measure: Change from Baseline Food stability
timeFrame: 6 months and 12 months
Other outcomes:
measure: Change from Baseline Diabetes Self-Efficacy
timeFrame: 6 months and 12 months
measure: Change from Baseline Diabetes Self-Care
timeFrame: 6 months and 12 months
Locations:
city: Oakland
country: United States
facility: Alameda County Community Food Bank
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Detroit
country: United States
facility: Gleaners Community Food Bank of Southeastern Michigan
state: Michigan
city: Houston
country: United States
facility: Houston Food Bank
state: Texas
Study officials:
affiliation: University of California, San Francisco
name: Hilary K Seligman, MD MAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seligman HK, Levi R, Ridberg R, Smith M, Hills N, Waxman E. Impact of Enhanced Food Pantry Services on Food Security among Adults with Diabetes Using a Crossover Study Design. Curr Dev Nutr. 2022 Feb 10;6(4):nzac021. doi: 10.1093/cdn/nzac021. eCollection 2022 Apr.
citation: Smith M, Rosenmoss S, Seligman HK. Point-of-Care Hemoglobin A1C Testing System in Community Settings: Challenges, Opportunities, and Measurement Characteristics. Prog Community Health Partnersh. 2020;14(3):327-335. doi: 10.1353/cpr.2020.0038.
citation: Seligman HK, Smith M, Rosenmoss S, Marshall MB, Waxman E. Comprehensive Diabetes Self-Management Support From Food Banks: A Randomized Controlled Trial. Am J Public Health. 2018 Sep;108(9):1227-1234. doi: 10.2105/AJPH.2018.304528. Epub 2018 Jul 19.