Integrating a Prescription Produce Program Within a Diabetes Prevention Program
ConditionPrediabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Diabetes Prevention Program (DPP)
BehavioralA 12-month lifestyle change program incorporating the latest evidence on self-efficacy, physical activity, and healthy diet.
Produce Prescription Plan (PPP)
BehavioralThe 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.
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: Prescription Produce Program (PPP) within a Diabetes Prevention Program (DPP)Experimental treatment 2 interventions
Group B: Diabetes Prevention Program (DPP) onlyPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Assessment of recruitment rates
Assess feasibility and acceptability by recording and measuring the recruitment rates.
Time frame
Baseline, 16 weeks, 6 months, and 12 months2
Assessment of enrollment rates
Assess feasibility and acceptability by recording and measuring the enrollment rates.
Time frame
Baseline, 16 weeks, 6 months, and 12 months3
Assessment of attendance
Assess feasibility and acceptability by recording and measuring the attendance rates.
Time frame
Baseline, 16 weeks, 6 months, and 12 months4
Assessment of retention rates
Assess feasibility and acceptability by recording and measuring the retention rates.
Time frame
Baseline, 16 weeks, 6 months, and 12 monthsSecondary outcomes
1
Assessment of food security needs
Using the Brief Social Needs evaluation to assess the participants food security needs using the Brief social needs including 2-item food security .
Time frame
Baseline, 16 weeks, 6 months, and 12 months2
Assessment of social needs
Using the American Academic of Family Physician Social Needs Screening form to assess the participants social needs. This assessment is a set of validated questions designed to help healthcare providers identify and address social determinants of health. Underlined answers generally indicate a positive response for a social need. For the Personal Safety section, a total numerical value greater than 10 indicates a positive screen.
Time frame
Baseline, 16 weeks, 6 months, and 12 months3
Assessment of diet quality
Using the Healthy Eating Index derived from DietID™,an assessment tool capturing dietary intake through innovative Diet Quality Photo Navigation (DQPN®) to assess the participants diet quality. The Diet ID scoring system provides a diet quality score on a 1-10 scale. A Diet ID score of 10 represents the highest quality (HEI 90-100), while a score of 1 represents the lowest.
Time frame
Baseline, 16 weeks, 6 months, and 12 months4
Assessment of medication adherence
Medication adherence will be recorded and measured for assessment
Time frame
Baseline, 16 weeks, 6 months, and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Virginia Commonwealth University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov