Blood Pressure, Diet, Healthy, HbA1c
Conditions
Keywords
Medically Tailored Groceries, Type 2 Diabetes, Hypertension, Multiple Cardiometabolic Morbidity, Food Is Medicine, Medically Tailored Meals, Elevated Blood Pressure
Brief summary
The investigators will conduct an ancillary study of participants in a completed RCT of medically tailored meals to determine whether transitioning these participants to a medically tailored groceries (MTG) program is a feasible approach to sustain health effects.
Detailed description
This ancillary study is a single arm, pre-post design among adults with co-existing type 2 diabetes and elevated to high blood pressure who do not currently qualify for medically tailored meals (MTMs) but received them as part of their participation in an 8-month RCT on MTMs and cardiometabolic outcomes. The purpose of the ancillary study is to determine whether transitioning participants from a MTM to a MTG program (i.e., a hybrid MTM to MTG intervention) is a feasible approach to improve outcomes and sustain health effects. Participants will receive one box of medically tailored groceries each week for a period of 4 months, with each box supporting preparation of approximately 10 meals per week. No additional baseline visit will be required, as measurements collected at the 8-month visit in the parent clinical trial will serve as baseline values for the ancillary study. All participants will have their HbA1c and blood pressure measured and complete questionnaires about their diet quality, health and lifestyle behaviors, and program engagement and implementation at 4 months post receiving their first MTG box.
Interventions
BEHAVIORALMedically Tailored Groceries
God's Love We Deliver's current MTG program (Health Harvest), which consists of weekly home-delivered MTG boxes, recipes and educational materials/webinars developed by Registered Dietitian Nutritionist for a 4-month period. The participants in the ancillary study will receive 1 MTG box/week which provides food sufficient for approximately 10 meals/week and includes fresh fruits, vegetables, whole grains, and proteins for a period of 4 months.
Sponsors
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Type 2 diabetes diagnosis (physician diagnosed or HbA1c greater than or equal to 6.5% or diabetes medication use) 2. Hypertension diagnosis (systolic blood pressure greater than or equal to 130 mmHg and/or diastolic blood pressure greater than or equal to 80 mmHg or physician diagnosis or hypertension medication use) or elevated blood pressure (defined as systolic blood pressure greater than or equal to 120 mmHg) 3. Participation in parent trial investigating the impact of an 8-month medically-tailored meals (MTMs) intervention on cardiometabolic outcomes among adults with type 2 diabetes and elevated to high blood pressure who do not currently qualify for MTMs.
Exclusion criteria
1. Cancer diagnosis 2. Undergoing cancer treatment 3. Non-English or non-Spanish speaking 4. Not cognitively able to complete study requirements 5. Severe psychiatric disorders 6. Inability to provide informed consent 7. Health conditions that could prevent safe participation or impact study outcomes (e.g., substance use disorder, dialysis, neurodegenerative conditions)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diet Quality | Baseline, 4 months | The Mediterranean Eating Pattern for Americans (MEPA) scale, which captures adherence to a heart healthy dietary pattern, will be used to assess diet quality. The MEPA score ranges from 0-16 with higher scores indicating better diet quality. The change in MEPA scores from baseline to 4 months will be calculated. |
| Change in HbA1c | Baseline, 4 months | A fast and accurate HbA1c fingerstick test will assess changes in glycemic control from baseline to 4 months. |
| Change in systolic blood pressure | Baseline, 4 months | The change in office systolic blood pressure (mmHg) from baseline to 4 months will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in diastolic blood pressure | Baseline, 4 months | The change in office diastolic blood pressure (mmHg) from baseline to 4 months will be calculated. |
| Acceptability of Implementation | 4 monthd | Acceptability will be measured by questionnaire. Items are adapted from the validated Acceptability of Implementation Measure (AIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better intervention acceptability. The items are analyzed individually and not summed to a total score. |
| Feasibility of Implementation | 4 months | Feasibility will be measured by questionnaire using items adapted from the validated Feasibility of Implementation Measure (FIM) and rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better feasibility. The items are analyzed individually and not summed to a total score. |
| Appropriateness of Implementation | 4 months | Appropriateness will be measured by questionnaire. Items are adapted from the validated Implementation Appropriateness Measure (IAM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better appropriateness. The items are analyzed individually and not summed to a total score. |
| Satisfaction with Intervention | 4 months | Satisfaction with the intervention components will be measured by questionnaire. Participants will rate their satisfaction with intervention by indicating how likely they are to recommend it to others on a 10-point scale with higher scores indicating greater satisfaction (net promoter score). They will also be asked to rate the quality of the intervention as poor, fair, good, very good, or excellent. The items are analyzed individually and not summed to a total score. |
| Food Insecurity | Baseline, 4 months | The USDA Household Food Security Survey (FSSM-6 item) will be administered at baseline, 3 months, and 8 months. The scores range from 0-6 such that a score of 0-1 indicates high or marginal food security, 2-4 indicates low food security, and 5-6 indicates very low food security. Changes in the score from baseline to follow up at 4 months. |
| Nutrition Insecurity | Baseline, 4 months | The Gretchen Swanson 4-item nutrition screener will be administered at baseline, 4 months (score range: 0-4 with higher scores indicating higher nutrition security). Changes in the score from baseline to follow up at 4 months will be evaluated. |
| Sleep Duration | Baseline, 4 months | Sleep duration will be self-reported using the Pittsburgh Sleep Quality Index (PSQI, score range: 0-21). Changes in self-reported habitual hours of sleep from baseline to follow up at 4 months will be evaluated. |
| Pittsburgh Sleep Quality Index | Baseline, 4 months | Global sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI, score range: 0-21). Changes in the overall PSQI score (continuous and categorical) and its components from baseline to follow up at 4 months will be evaluated. |
| Self-rated health | Baseline, 4 months | Participant will rate their health as excellent, very good, good, fair, or poor at baseline,4 months. Changes in self-rated health from baseline to follow up at 4 months will be computed. |
| General Health Status | Baseline, 4 months | The EuroQoL 5-Dimension 5-Level (EQ-5D-5L) will be used to measure general health status and quality of life. This will be captured based on five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Based on the participant's response for reach dimension they will receive a 1-digit number, and the digits for the five dimensions will be combined into a 5-digit number that describes the patient's health state. This study will evaluate changes in this measure from baseline to follow up at 4 months. I |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNour Makarem, PhD, FAHA
Columbia University
Outcome results
None listed