NOURISH HEARTS: Nutrition Outreach and Understanding: Research In Serving Hearts Through Healthy Eating And Tailored Support
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Retention Rate
研究概览
简要总结
This study is a human-centered, three-arm, parallel-group, randomized control, implementation trial (n=75) to compare MTM (Medically Tailored Meals) only (14 meals delivered weekly for 10 weeks) vs. MTM + SMA (Shared Medical Appointments; once weekly sessions for 10 weeks) vs. a wait-list control group (MTM-Later) in patients with hypertension, type 2 diabetes, obesity, and/or metabolic syndrome. All intervention components will be culturally congruent (e.g., MTMs will include food that converges with culturally relevant diets and SMAs will be delivered by individuals with racial concordance to the target community). Primary outcomes will be implementation (recruitment and retention rates) and feasibility (engagement and satisfaction). Participants will be recruited from Cleveland Clinic's South Pointe Hospital in Warrensville Heights, a predominantly Black community with low socioeconomic status and high cardiovascular disease morbidity.
详细描述
Subjects will be randomized into one of the three arms within the study:
Medically Tailored Meals (MTMs):
Collaborative agreements are in place with Performance Kitchen to prepare 2 meals/day for 7 days/week for 10 weeks at a discount for all participants (n =75) for this trial. Meals will be prepared based on evidence-based nutritional recommendations for the Mediterranean diet and that align with 2021 American Heart Association Dietary Guidance. Individuals randomized to MTMs will receive electronic educational materials from the MTM + SMA group after the completion of the post-intervention study assessment.
Medically Tailored Meals + Shared Medical Appointments (MTMs + SMAs):
Identical MTMs that are provided in the MTM only group will also be provided in the MTM + SMA group. The SMA will be delivered weekly for 10 weeks and will be modeled after the investigator's pilot study. This includes practice with behavior change principles (i.e., selection of healthy food options). The provider, dietician, chef, and health coach will be members of the Black community to ensure racial concordance between educators and participants, a critical feature that improves communication, trust, and health outcomes in behavioral health interventions. The provider, dietician, and health coach are professionals currently employed within the Department of Wellness and Preventive Medicine. Fidelity will be ensured by using a session fidelity checklist that will be completed by each facilitator. To maximize retention, during consent via (telephone or in-person the study coordinator will establish rapport and set study expectations, including what SMAs entail and the time commitment for the session to minimize attrition. SMA visit reminder emails will be sent to participants through their EHR portal and/or via email.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The PI and the study statistician will be masked to treatment condition when conducting initial data analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-identification as Black or African American
- •Ability to speak and read English
- •Age ≥ 18 years old
- •Diagnosis of any of the following: a) Hypertension (>130/80), and ever treated for hypertension; b) Type 2 Diabetes Mellitus (HgbA1c ≥ 8%); c) Metabolic Syndrome; d) Obesity (BMI ≥ 30)
- •Access to a web-enabled device (phone, tablet, computer)
- •Received care at Cleveland Clinic South Pointe Hospital or Main Campus within the past 6 months
排除标准
- •Stage C and D heart failure
- •Advanced valvular heart disease
- •Advanced heart failure class D defined as heart failure symptoms impairing daily quality of life and/or resulting in recurrent hospitalizations (>1) per previous 12 months
- •Insulin requiring type II diabetes mellitus
- •Type I diabetes mellitus
- •Advanced chronic kidney disease (≥ Stage 4)
- •BMI > 45 kg/m2
- •Patients who are in another study or nutritional support program supplying meals
- •Patients who are receiving a medically prescribed diet with a specific nutritional profile
- •Receiving active cancer treatment, not including endocrine therapy
- •Inability to participate in the demands and requirements of the trial
- •Significant cognitive impairment
结局指标
主要结局
Retention Rate
时间窗: Baseline through Week 10
Retention is a measure of treatment implementation. Retention rate will be measured by # of completed assessments at week 10/# randomized to treatment arm.
Recruitment Rate
时间窗: Baseline through Week 10
Recruitment is a measure of treatment implementation. Recruitment rate will be measured by # of participants enrolled in study/# passed eligibility screening.
SMA Attendance
时间窗: Baseline through Week 10
Engagement will be assessed by Shared Medical Appointment (SMA) session attendance over the 10 week period.
MTMs Consumed
时间窗: Baseline through Week 10
Engagement will be assessed by proportion of Medically Tailored Meals (MTMs) consumed.
Satisfaction of the Intervention
时间窗: Baseline through Week 10
Satisfaction of MTM vs. MTM + SMA will be assessed using the Net Promoter Score (scale of 0 to 10; 9-10 being promoters, 7-8 being passives, and 0-6 being detractors)
次要结局
- Waist/Hip Circumference(Baseline and Week 10)
- Systolic and Diastolic Blood Pressure (mmHg)(Baseline and Week 10)
- Hemoglobin A1c (HbA1c, mmol/mol)(Baseline and Week 10)
- High Sensitivity C-Reactive Protein (hsCRP, mg/dL)(Baseline and Week 10)
- Eating Behavior(Baseline and Week 10)
- Uric Acid (mg/dL)(Baseline and Week 10)
- Vitamin D 25 Hydroxy (ng/mL)(Baseline and Week 10)
- Body Weight(Baseline and Week 10)
- Trimethylamine N-oxide (TMAO, uM)(Baseline and Week 10)
研究者
Amanda Shallcross
Director, Center for Research and Training, Department of Wellness and Preventative Medicine
The Cleveland Clinic