Cardiovascular Risk Reduction for Adults With Food Insecurity Using Structured Incentives

Официальное название

Cardiovascular Risk Reduction for Adults With Food Insecurity Using Structured Incentives (CVD-FIT)

Обзор

The overarching aim of this proposal is to test the efficacy and cost-effectiveness of CVD-FIT, a novel, multi-component intervention that includes three components: 1) monthly income supplementation; 2) weekly structured incentive for the purchase of healthy food options; and 3) evidence-based telephone delivered CVD risk reduction education and skills training in African Americans with food insecurity.

Подробное описание

Study Overview: 200 African American adults at risk for CVD with food insecurity will be randomized 1:1 to CVD-FIT or enhanced usual care (CVD risk reduction education). Each patient will be followed for 12 months, with study visits at baseline, 3, 6, and 12 months. The primary outcome will be 10-year CVD risk using the Pooled Cohort Equation at 12 months post-randomization while the secondary outcomes will be quality of life at 12 months post-randomization and cost-effectiveness of the CVD-FIT intervention compared to enhanced usual care.

Patient Randomization. A permuted block randomization method will be used to assign subjects to intervention or control. All subjects who are randomized will be entered into the study database and analyzed according to CONSORT guidelines.

Description of the CVD-FIT Intervention: The CVD-FIT intervention will incorporate 1) $100 monthly income supplementation; 2) $50 weekly structured incentive for the purchase of healthy food options; and 3) evidence-based telephone delivered CVD risk reduction education and skills training.

Enhanced Usual Care Control Group: Participants randomized to the enhanced usual care group will receive the same mailed education and health educator delivered education and skills training sessions as the CVD-FIT intervention group.

Вмешательства

• Поведенческое CVD-FIT
  The structured incentive will include monthly supplemental income plus weekly reimbursement for the purchase of healthy food options. Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator.
• Поведенческое Enhanced Usual Care
  Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator.

Первичные конечные точки

• 10-Year CVD Risk [Срок оценки: baseline, 3-months, 6-months, and 12-months post randomization]
• CVD Risk - PREVENT [Срок оценки: baseline, 3-months, 6-months, and 12-months post randomization]

Вторичные конечные точки (1)

• Physical and Mental Health Related Quality of Life [Срок оценки: baseline, 3-months, 6-months, and 12-months post randomization]

Критерии участия

Критерии включения

• self-report as African American/non-Hispanic Black
• screen positive for food insecurity over the past 12-months using a food insecurity risk tool developed through completion of the research team's current NIH funded R01 (R01MD013826)
• at risk for CVD defined as age ≥40 years and having a clinical diagnosis of diabetes, or hypertension, or hyperlipidemia, or being overweight/obese (defined as a BMI>25), or being a current smoker
• able to communicate in English.

Критерии исключения

• Mental confusion on interview suggesting significant dementia
• Participation in other cardiovascular disease clinical trials
• Alcohol or drug abuse/dependency based on screening using CAGE questionnaire
• Active psychosis or acute mental disorder based on self-report
• Life expectancy <12 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

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• University at Buffalo — Buffalo

Идентификаторы

NCT: NCT06818669 · R01MD018721 · 1R01MD018721-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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