Integrating a Prescription Produce Program Within a Diabetes Prevention Program

Official title

Integrating a Prescription Produce Program Within a Diabetes Prevention Program to Address Health Inequities Among Adults

Overview

Type 2 Diabetes remains a major chronic disease among adults in the United States. A way to prevent Type 2 Diabetes is to engage in a diabetes prevention program. In the diabetes prevention program, individuals at risk of Type 2 Diabetes meet with a health coach to learn effective ways to build health behaviors around diet and physical activity. Individuals who participate in the diabetes prevention program are more likely to lose weight and eat a healthy diet.

Detailed description

The diabetes prevention program does not provide support for major factors influencing Type 2 diabetes, such as food insecurity or the challenge of accessing and eating healthy food to maintain optimal health. Millions of adults who are at risk of Type diabetes face challenges such as food insecurity and access to healthcare, transportation, and housing. A prescription produce program is a community-based initiative that supports an individual who may face food insecurity to access healthy fruits and vegetables and receive health advice and resources to manage their health, including referrals for health services, housing, and transportation. This research examines whether or not a diabetes prevention program integrating a prescription produce program provides more benefits in preventing Type 2 diabetes compared to a regular diabetes prevention program. Subjects in this study may lose weight, increase their knowledge of health, and provide additional services to manage their health.

Interventions

• Behavioral Diabetes Prevention Program (DPP)
  A 12-month lifestyle change program incorporating the latest evidence on self-efficacy, physical activity, and healthy diet.
• Behavioral Produce Prescription Plan (PPP)
  The research intervention in this study is the DPP + Produce Prescription Plan (DPP+PPP). Besides receiving the DPP, the intervention group participants will receive bags of fresh fruits and vegetables, attend four cooking demonstrations, and if there are positive screens for social needs, be referred to work with a community-based wellness program to access resources.

Primary outcome measures

• Assessment of recruitment rates [Time frame: Baseline, 16 weeks, 6 months, and 12 months]
• Assessment of enrollment rates [Time frame: Baseline, 16 weeks, 6 months, and 12 months]
• Assessment of attendance [Time frame: Baseline, 16 weeks, 6 months, and 12 months]
• Assessment of retention rates [Time frame: Baseline, 16 weeks, 6 months, and 12 months]
• Assessment of blood glucose [Time frame: Baseline, 16 weeks, 6 months, and 12 months]
• Assessment of weight [Time frame: Baseline, 16 weeks, 6 months, and 12 months]

Secondary outcome measures (7)

• Assessment of food security needs [Time frame: Baseline, 16 weeks, 6 months, and 12 months]
• Assessment of social needs [Time frame: Baseline, 16 weeks, 6 months, and 12 months]
• Assessment of diet quality [Time frame: Baseline, 16 weeks, 6 months, and 12 months]
• Assessment of medication adherence [Time frame: Baseline, 16 weeks, 6 months, and 12 months]
• Assessment of wellness goals set and met [Time frame: Baseline, 16 weeks, 6 months, and 12 months]
• Assessment of physical activity [Time frame: Baseline, 16 weeks, 6 months, and 12 months]
• Assessment of Blood pressure [Time frame: Baseline, 16 weeks, 6 months, and 12 months]

Eligibility criteria

Inclusion criteria

• ≥age 18
• rationale: adolescents who are at-risk of T2DM may have unique needs that will not be addressed in this study
• Most recent BMI ≥ 25kg/m 2 and not pregnant
• rationale: elevated BMI is associated with higher risk of developing T2DM
• Elevated glucose as evidenced by one of the following criteria:
• Hemoglobin A1c 5.7-6.4% indicative of prediabetes within the last 36 months
• Fasting blood glucose 100-125mg/dl or 2-hour glucose 140-199mg/dl within the last six months
• Physician diagnosis of prediabetes (impaired fasting glucose, impaired glucose intolerance)
• These criteria indicate the presence of prediabetes and places individuals are risk of T2DM
• Speak, read, and understand English
• rationale: current version of PPP intervention (cooking classes) is available in English
• Have a working U.S.- based phone number
• rationale: participants must have a working phone number because they will receive automated text messages as reminders to receive session reminders; participants must have a working phone number in case adverse event monitoring contacts are required
• Able to attend study-related sessions at the Health Hub @ 25th over the year long study (i.e., weekly for 4 months, then monthly for 7 months)
• rationale: participants must be able to attend study activities at the community site in order to engage in the intervention and study related sessions.

Exclusion criteria

• Individuals with HbA1c or glucose levels above the indicated glucose ranges will be advised to see their physician and excluded from participation unless they receive physician consent to participate.
• Pregnant adults (>18 years old) will not be included in this current study because prediabetes (HbA1c levels between 5.7% - 6.4% within the last 36 months) during pregnancy presents unique physiological challenges that the study intervention does not address.
• Pregnancy status will be based on participants self-report. We will not provide any pregnancy tests prior to enrollment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

United States · 1 center

• Virginia Commonwealth University — Richmond

Identifiers

NCT: NCT07472712 · HM300000239 · R01DK142965

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗