MTM2MTG Pilot Ancillary Study

Официальное название

Medically Tailored Groceries for Cardiovascular Health

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Medically 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.

Первичные конечные точки

• Change in Diet Quality [Срок оценки: Baseline, 4 months]
• Change in HbA1c [Срок оценки: Baseline, 4 months]
• Change in systolic blood pressure [Срок оценки: Baseline, 4 months]

Вторичные конечные точки (11)

• Change in diastolic blood pressure [Срок оценки: Baseline, 4 months]
• Acceptability of Implementation [Срок оценки: 4 monthd]
• Feasibility of Implementation [Срок оценки: 4 months]
• Appropriateness of Implementation [Срок оценки: 4 months]
• Satisfaction with Intervention [Срок оценки: 4 months]
• Food Insecurity [Срок оценки: Baseline, 4 months]
• Nutrition Insecurity [Срок оценки: Baseline, 4 months]
• Sleep Duration [Срок оценки: Baseline, 4 months]
• Pittsburgh Sleep Quality Index [Срок оценки: Baseline, 4 months]
• Self-rated health [Срок оценки: Baseline, 4 months]
• General Health Status [Срок оценки: Baseline, 4 months]

Критерии участия

Критерии включения

• Type 2 diabetes diagnosis (physician diagnosed or HbA1c greater than or equal to 6.5% or diabetes medication use)
• 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)
• 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.

Критерии исключения

• Cancer diagnosis
• Undergoing cancer treatment
• Non-English or non-Spanish speaking
• Not cognitively able to complete study requirements
• Severe psychiatric disorders
• Inability to provide informed consent
• Health conditions that could prevent safe participation or impact study outcomes (e.g., substance use disorder, dialysis, neurodegenerative conditions)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Columbia University Mailman School of Public Health — New York

Идентификаторы

NCT: NCT07620808 · AAAV0681 - Ancillary Study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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