MTM2MTG Pilot Ancillary Study (MTM2MTG)
2026年8月18日 更新者：Nour Makarem, PhD、Columbia University
Medically Tailored Groceries for Cardiovascular Health
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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New York
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New York、New York、美国、10032
- Columbia University Mailman School of Public Health
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Ancillary Study: Medically Tailored Groceries (MTG) Program
Participants in this ancillary study are adults with 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 a RCT for 8 months.
This ancillary study evaluates whether transitioning from MTMs to MTGs is a feasible approach to maintain MTM intervention health effects and could be a better tolerated intervention for participants who are not engaged with the MTM intervention.
Participants will receive one MTG box per week for 4 months, supporting preparation of ~10 heart healthy, diabetes appropriate meals per week.
Outcomes will be assessed at the end of the 4-month MTG intervention period using questionnaires and clinic measurements (blood pressure and HbA1c).
The 8-month primary endpoint visit for the parent RCT will serve as the baseline for this study.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change in Diet Quality
大体时间：Baseline, 4 months
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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.
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Baseline, 4 months
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Change in HbA1c
大体时间：Baseline, 4 months
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A fast and accurate HbA1c fingerstick test will assess changes in glycemic control from baseline to 4 months.
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Baseline, 4 months
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Change in systolic blood pressure
大体时间：Baseline, 4 months
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The change in office systolic blood pressure (mmHg) from baseline to 4 months will be calculated.
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Baseline, 4 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in diastolic blood pressure
大体时间：Baseline, 4 months
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The change in office diastolic blood pressure (mmHg) from baseline to 4 months will be calculated.
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Baseline, 4 months
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Acceptability of Implementation
大体时间：4 monthd
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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.
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4 monthd
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Feasibility of Implementation
大体时间：4 months
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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.
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4 months
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Appropriateness of Implementation
大体时间：4 months
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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.
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4 months
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Satisfaction with Intervention
大体时间：4 months
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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.
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4 months
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Food Insecurity
大体时间：Baseline, 4 months
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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.
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Baseline, 4 months
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Nutrition Insecurity
大体时间：Baseline, 4 months
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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.
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Baseline, 4 months
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Sleep Duration
大体时间：Baseline, 4 months
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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.
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Baseline, 4 months
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Pittsburgh Sleep Quality Index
大体时间：Baseline, 4 months
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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.
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Baseline, 4 months
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Self-rated health
大体时间：Baseline, 4 months
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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.
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Baseline, 4 months
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General Health Status
大体时间：Baseline, 4 months
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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
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Baseline, 4 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Nour Makarem, PhD, FAHA、Columbia University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2027年6月1日
研究完成 (估计的)
2027年6月1日
研究注册日期
首次提交
2026年5月27日
首先提交符合 QC 标准的
2026年5月27日
首次发布 (实际的)
2026年6月2日
研究记录更新
最后更新发布 (实际的)
2026年8月19日
上次提交的符合 QC 标准的更新
2026年8月18日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.