Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Location status: Recruiting
NCT Number: NCT07472712
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Richmond, Virginia, 23298, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A 12-month lifestyle change program incorporating the latest evidence on self-efficacy, physical activity, and healthy diet.
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.
Time frame: Baseline, 16 weeks, 6 months, and 12 months
Assess feasibility and acceptability by recording and measuring the recruitment rates.
Time frame: Baseline, 16 weeks, 6 months, and 12 months
Assess feasibility and acceptability by recording and measuring the enrollment rates.
Time frame: Baseline, 16 weeks, 6 months, and 12 months
Assess feasibility and acceptability by recording and measuring the attendance rates.
Time frame: Baseline, 16 weeks, 6 months, and 12 months
Assess feasibility and acceptability by recording and measuring the retention rates.
Time frame: Baseline, 16 weeks, 6 months, and 12 months
Blood glucose (hemoglobin A1c) will be recorded and measured to asses the blood glucose levels.
Time frame: Baseline, 16 weeks, 6 months, and 12 months
Weight will be will be recorded and measured for assessment
Time frame: Baseline, 16 weeks, 6 months, and 12 months
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 months
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 months
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 months
Medication adherence will be recorded and measured for assessment
Time frame: Baseline, 16 weeks, 6 months, and 12 months
Wellness goals set and met will be recorded and measured for assessment
Time frame: Baseline, 16 weeks, 6 months, and 12 months
Physical activity will be recorded and measured for assessment using International Physical Activity Questionnaire (IPAQ) measures time spent sitting, light, moderate, and vigorous activity over a set period (e.g., past 7 days), increased activity time at a higher rate of activity will indicate increased physical activity.
Time frame: Baseline, 16 weeks, 6 months, and 12 months
Both systolic and diastolic blood pressure will be recorded and measured for assessment.
Contact information is provided by the study sponsor or research team.
Virginia Commonwealth University
Other
Integrating a Prescription Produce Program Within a Diabetes Prevention Program to Address Health Inequities Among Adults
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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