Comestibles más intervención de estilo de vida de múltiples componentes para adultos con hipertensión y diabetes tipo 2 (DASH-Life)
Comestibles más intervención de estilo de vida de múltiples componentes para adultos con hipertensión y diabetes tipo 2 que residen en desiertos de alimentos urbanos (Dash-Life): ensayo clínico aleatorizado piloto
People with high blood pressure and diabetes often have low levels of key nutrients as a result of not eating enough fresh fruits and vegetables. Research studies suggest that these nutrients can lower blood pressure and blood sugar. This study will investigate if providing encouragement to adopt this healthy and nutritious way of eating and providing guidance on weight management will lower blood pressure and blood sugar. The DASH-Life research study will recruit adults with hypertension and type 2 diabetes who live in Baltimore metro areas that don't have many stores selling healthy foods. The DASH-Life research study is 6 months long. Participants will be randomly assigned to one of two groups: 1) Self-Shopping DASH (S-DASH) diet advice group, or 2) Coaching DASH (C-DASH) diet advice group.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Baltimore, Maryland, Estados Unidos, 21207
- Johns Hopkins ProHealth Clinical Research Unit
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age 18 years or older
- Diabetes Mellitus Type 2 defined by: self-reported type 2 diabetes diagnosis, or HbA1c>=6.5%, or treatment of diabetes with diabetes medications(s)
- Baseline systolic BP 110-159 mmHg (with or without medications.)
- Serum potassium level >3.0 and <5 mmol/L,
- Estimated glomerular filtration rate (eGFR) >=45 mL/min/1.73m2.
- Willing and able to complete required procedures in English.
- Living in Healthy Food Priority Area in Baltimore; the US Department of Agriculture (USDA) defined low income, low access areas, or census blocks with area deprivation index (ADI) 60 and above (State Decile>=6.)
Exclusion Criteria:
- Hypoglycemia requiring hospitalization or the assistance of another person in the last 6 months
- Cardiovascular event within 6 months
- Unstable dose (i.e., change in the 3 months prior to screening or prior to randomization) glucagon-like peptide-1 (GLP-1) receptor agonists
- HbA1c ≥ 10%
- Type 1 diabetes
- Baseline systolic BP < 110 mmHg
- Weight >400 lbs due to the maximum weight on study scale
- Chronic disease that might interfere with trial participation
- Current participation in another clinical trial that might affect blood pressure, weight loss, diabetes, or ability to adhere to study procedures
- Current participation in program with conflicting dietary guidance (i.e., meal replacement or keto diets)
- Unwillingness or inability to adopt a DASH-like diet
- Planning to leave area in the next 6 months
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Grupo de asesoramiento de dieta de autoportando Dash (S-Dash)
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Participants assigned to the S-DASH group will receive a brochure about the DASH eating plan. For the first three months, Participants will also receive a gift card to shop at a local supermarket. During months 4-6, participants will be asked to continue following the DASH eating plan listed in the brochure but will no longer be provided the grocery gift card. |
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Experimental: Comerciales de tablero a medida dirigidos por el entrenador más intervención de estilo de vida (C-Dash)
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Participants assigned to the C-DASH group will meet by telephone with the study coach for 1 hour, and then have brief weekly conversations (about 15-30 minutes) by phone during the first three months. During these weekly calls, the study coach will assist participant with selecting fruits, vegetables, nuts, and beans. During months 4-6, the study coach will continue to work with participant to set goals for following the DASH-Life way of eating, but the study will no longer provide a weekly food allowance to purchase groceries. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility as assessed by the number of participants enrolled
Periodo de tiempo: Baseline
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The observed count of responses to the prescreening will be summarized. Recruitment yields at screening visit and randomization visit will be derived. |
Baseline
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Acceptability as assessed by the Acceptability of the Intervention Measure survey
Periodo de tiempo: 3 months
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Acceptability of the intervention will be quantitatively measured by the Acceptability of Intervention Measure (AIM) survey. The survey consists of 4 items, each measured on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree). The score is calculated as the mean of the responses to the 4 items. A higher score is better. |
3 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jessica Yeh, PhD, Johns Hopkins University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00425074
- P50MD017348 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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