Groceries Plus Multi-Component Lifestyle Intervention for Adults With Hypertension and Type 2 Diabetes

Официальное название

Groceries Plus Multi-Component Lifestyle Intervention for Adults With Hypertension and Type 2 Diabetes Residing in Urban Food Deserts (DASH-Life): Pilot Randomized Clinical Trial

Обзор

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.

Вмешательства

• Поведенческое Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention
  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
• Поведенческое Self-Shopping DASH diet advice
  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.

Первичные конечные точки

• Feasibility as assessed by the number of participants enrolled [Срок оценки: Baseline]
• Acceptability as assessed by the Acceptability of the Intervention Measure survey [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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 120-159 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.)

Критерии исключения

• Hypoglycemia requiring hospitalization or the assistance of another person in the last 6 months
• Cardiovascular event within 6 months
• On diabetes or weight loss medications such as glucagon-like peptide 1 (GLP-1), GLP-1/glucose-dependent insulin-releasing peptide (GIP), insulin, or any combination of these medications
• HbA1c ≥ 10%
• Type 1 diabetes
• Baseline systolic BP < 100 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

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Johns Hopkins ProHealth Clinical Research Unit — Baltimore

Идентификаторы

NCT: NCT06921356 · IRB00425074 · P50MD017348

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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