MTM2MTG Pilot Ancillary Study (MTM2MTG)
1 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Inscripción por invitación
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
80
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10032
- Columbia University Mailman School of Public Health
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Diet Quality
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in diastolic blood pressure
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Nour Makarem, PhD, FAHA, Columbia University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
1 de junio de 2027
Finalización del estudio (Estimado)
1 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
27 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de mayo de 2026
Publicado por primera vez (Actual)
2 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AAAV0681 - Ancillary Study
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Data may be shared upon request to PI.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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