Assessing Health Outcomes in Low-income Diabetics Who Receive Monthly Boxes of Healthy Food at Clinic

NCT02917902 | Completed

• 1 other identifier: 141481
• Study Type: interventional
• Target: 201
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the effectiveness of providing monthly boxes of nutritious foods to low-income patients with diabetes on site at Free Clinics with referrals to off-site food pantries on diabetes related health outcomes

Conditions

Diabetes Mellitus, Type 2

Keywords

student-run free clinic; food supply; food insecure; medically uninsured; medically underserved

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c (measured as part of routine care)

  primary outcome measure is change in HbA1c from baseline to 3 months, 6 months, 9 months (9months is for delayed intervention only)

Secondary Outcomes (9)

• Change in Food Insecurity

  baseline, 3 months, 6 months, 9 months (9 months is for delayed intervention only)

• Change in Diabetes Distress

  baseline, 3 months, 6 months, 9 months (9 months is for delayed intervention only)

• Change in Fruit and Vegetable Intake

  baseline, 3 months, 6 months, 9 months (9 months is for delayed intervention only)

• Change in Hypoglycemic Events

  baseline, 3 months, 6 months, 9 months (9 months is for delayed intervention only)

• Change in Medication adherence

  baseline, 3 months, 6 months, 9 months (9 months is for delayed intervention only)

Study Arms (2)

Immediate intervention

EXPERIMENTAL

Intervention: Food boxes. Monthly boxes of food for 6 months, along with brief educational information from food pantry staff regarding eating healthy on a budget, starting immediately after randomization. Patients will continue to receive routine medical care at the Free Clinic.

Other: Food boxes

Delayed intervention

OTHER

Intervention: Food boxes. Monthly boxes of food for 6 months, along with brief educational information from food pantry staff regarding eating healthy on a budget, starting 3 months after randomization. Patients will continue to receive routine medical care at the Free Clinic. Participants will be given referrals to local food pantries in their neighborhoods that provide food free of charge as well as referrals for CalFresh (formerly known as food stamps) during the 3 month time frame when patients are waiting to receive food distributions on site at the clinics.

Other: Food boxes

Interventions

Food boxes OTHER

Box of approximately 50 pounds of nutritious foods provided by food pantry, including fresh fruits and vegetables as well as shelf-stable items selected for diabetic patients, along with brief education provided by food pantry staff.

Delayed intervention; Immediate intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• type 2 diabetes
• receiving medical care at one of the UC San Diego Student-run Free Clinic Sites

You may not qualify if:

• unable to attend monthly food distribution onsite (pt states will not able to come monthly due to any kind of conflict (work, transportation, childcare), or is not interested in coming monthly due to time or transportation burden)

Sponsors & Collaborators

• University of California, San Diego: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sunny Smith

  Clinical Professor, Department of Family Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Department of Family Medicine and Public Health

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: September 28, 2016
• Study Start: January 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 28, 2016

Record last verified: 2016-09