Prediabetes
Conditions
Keywords
Health Coach, Food Insecurity, Prevention Program, Diabetes Prevention
Brief summary
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
BEHAVIORALDiabetes Prevention Program (DPP)
A 12-month lifestyle change program incorporating the latest evidence on self-efficacy, physical activity, and healthy diet.
BEHAVIORALProduce 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.
Sponsors
Virginia Commonwealth University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A feasibility and pilot study using a mixed method design with a two-arm parallel active control randomized trial and two focus groups. It is a pragmatic, real-world trial conducted in the community.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of recruitment rates | Baseline, 16 weeks, 6 months, and 12 months | Assess feasibility and acceptability by recording and measuring the recruitment rates. |
| Assessment of enrollment rates | Baseline, 16 weeks, 6 months, and 12 months | Assess feasibility and acceptability by recording and measuring the enrollment rates. |
| Assessment of attendance | Baseline, 16 weeks, 6 months, and 12 months | Assess feasibility and acceptability by recording and measuring the attendance rates. |
| Assessment of retention rates | Baseline, 16 weeks, 6 months, and 12 months | Assess feasibility and acceptability by recording and measuring the retention rates. |
| Assessment of blood glucose | Baseline, 16 weeks, 6 months, and 12 months | Blood glucose (hemoglobin A1c) will be recorded and measured to asses the blood glucose levels. |
| Assessment of weight | Baseline, weekly for the first 16 weeks, them monthly from 5 to 12 months | Weight will be will be recorded and measured for assessment |
| Minutes of physical activity | weekly for the first 16 weeks, them monthly from month 5 to 12. | average amount (in minutes) of physical activity completed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of food security needs | 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 . |
| Assessment of social needs | 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. |
| Assessment of diet quality | 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. |
| Assessment of medication adherence | Baseline, 16 weeks, 6 months, and 12 months | Medication adherence will be recorded and measured for assessment |
| Assessment of wellness goals set and met | Baseline, 16 weeks, 6 months, and 12 months | Wellness goals set and met will be recorded and measured for assessment |
| Assessment of physical activity | 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. |
| Assessment of Blood pressure | Baseline, 16 weeks, 6 months, and 12 months | Both systolic and diastolic blood pressure will be recorded and measured for assessment. |
Countries
United States
Contacts
CONTACTAna Diallo
PRINCIPAL_INVESTIGATORAna Diallo
Virginia Commonwealth University
Outcome results
None listed