MTM2MTG Pilot Ancillary Study (MTM2MTG)
2026年6月1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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
80
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
New York
-
New York、New York、アメリカ、10032
- Columbia University Mailman School of Public Health
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Diet Quality
時間枠：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.
|
Baseline, 4 months
|
|
Change in HbA1c
時間枠：Baseline, 4 months
|
A fast and accurate HbA1c fingerstick test will assess changes in glycemic control from baseline to 4 months.
|
Baseline, 4 months
|
|
Change in systolic blood pressure
時間枠：Baseline, 4 months
|
The change in office systolic blood pressure (mmHg) from baseline to 4 months will be calculated.
|
Baseline, 4 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in diastolic blood pressure
時間枠：Baseline, 4 months
|
The change in office diastolic blood pressure (mmHg) from baseline to 4 months will be calculated.
|
Baseline, 4 months
|
|
Acceptability of Implementation
時間枠：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.
|
4 monthd
|
|
Feasibility of Implementation
時間枠：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.
|
4 months
|
|
Appropriateness of Implementation
時間枠：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.
|
4 months
|
|
Satisfaction with Intervention
時間枠：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.
|
4 months
|
|
Food Insecurity
時間枠：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.
|
Baseline, 4 months
|
|
Nutrition Insecurity
時間枠：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.
|
Baseline, 4 months
|
|
Sleep Duration
時間枠：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.
|
Baseline, 4 months
|
|
Pittsburgh Sleep Quality Index
時間枠：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.
|
Baseline, 4 months
|
|
Self-rated health
時間枠：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.
|
Baseline, 4 months
|
|
General Health Status
時間枠：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
|
Baseline, 4 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Nour Makarem, PhD, FAHA、Columbia University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2027年6月1日
研究の完了 (推定)
2027年6月1日
試験登録日
最初に提出
2026年5月27日
QC基準を満たした最初の提出物
2026年5月27日
最初の投稿 (実際)
2026年6月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月3日
QC基準を満たした最後の更新が送信されました
2026年6月1日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- AAAV0681 - Ancillary Study
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Data may be shared upon request to PI.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
血圧の臨床試験
-
Hangzhou Agile Groups Network Technology Co., Ltd.完了