Health TrialsbyHealthPanel

Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)

ConditionsDiabetes Mellitus, Type 2Nutrition PoorFood Deprivation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University

About this trial

This is a pragmatic randomized controlled trial (pRCT) that aims to test the effect of produce provision, diabetes education, and community referrals on hemoglobin A1c levels in individuals with type 2 diabetes experiencing food insecurity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Type 2 Diabetes based on American Diabetes Association Criteria

Hemoglobin A1c ≥ 7.5%

Screen Positive on 2-item Food Security Screener

Disqualifiers

Unwilling to Attest to Release of Information to Mid-Ohio Food Collective

Trial design

Design model

Factorial

Treatments tested in this trial

  • Mid-Ohio Food Farmacy

    Behavioral

    The Food Farmacy arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective.

  • Mid-Ohio Food Farmacy + Cooking for Diabetes

    Behavioral

    The Food Farmacy + Cooking for Diabetes Arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective and Cooking for Diabetes, a 6-week diabetes self-management education and support and culinary education intervention.

  • Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub

    Behavioral

    The Food Farmacy + Health Impact Ohio Pathways Hub Arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective and has social needs address through a community health worker model at the direction of Health Impact Ohio. The community health worker meets with participants, evaluates and addresses non-medical, health-related social needs.

  • Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub

    Behavioral

    The Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub Arm receives all 3 interventions. Participants receive weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective, Cooking for Diabetes, a 6-week diabetes self-management education and support and culinary education intervention and has social needs addressed through a community health worker model at the direction of Health Impact Ohio. The community health worker meets with participants, evaluates and addresses non-medical, health-related social needs.

Treatment groups

568 Participants
are divided into 4 treatment groups
Group A: Mid Ohio Food FarmacyActive comparator 1 intervention
Group B: Mid-Ohio Food Farmacy + Cooking for DiabetesExperimental treatment 1 intervention
Group C: Mid-Ohio Food Farmacy + Health Impact Ohio Pathways HubExperimental treatment 1 intervention
Group D: Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways HubExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Hemoglobin A1c

measures average blood sugar levels over the past 3 months

Time frame
3 months

Secondary outcomes

1

Change in Hemoglobin A1c

measures average blood sugar levels over the past 3 months

Time frame
6 months
2

Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale

Diabetes self-efficacy measured via the diabetes self-efficacy scale. The Diabetes Self-Efficacy Scale has a minimum score of 10 and a maximum score of 80. A higher score indicates higher diabetes self-efficacy.

Time frame
3 months
3

Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale

Diabetes self-efficacy measured via the diabetes self-efficacy scale. The Diabetes Self-Efficacy Scale has a minimum score of 10 and a maximum score of 80. A higher score indicates higher diabetes self-efficacy.

Time frame
6 months
4

Change in food security assessed using the 18-item U.S. Household Food Security Survey Module

Food security will be assessed using the 18-item U.S. Household Food Security Survey Module. For households with one or more children: * Raw score zero-High food security * Raw score 1-2-Marginal food security * Raw score 3-7-Low food security * Raw score 8-18-Very low food security For households with no child present: * Raw score zero-High food security * Raw score 1-2-Marginal food security * Raw score 3-5-Low food security * Raw score 6-10-Very low food security

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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