Diabetes Medical Nutrition Therapy in Southeastern African American Women
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 291
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
A two-arm randomized controlled trial design will be used. Participants will include 291 African American women with type 2 diabetes that are at risk for development and/or progression of diabetes complications. Both arms, diabetes medical nutrition therapy (MNT) and diabetes MNT plus motivational interviewing (MI), will include: 1) a 3-month active intervention period of six biweekly (every other week), group-based, trained nutritionist-facilitated sessions; 2) a 3-month maintenance intervention period, which will include one group-based maintenance support session; and 3) a 6-month inactive period (no contact). The differences between arms is the integration of culturally-adapted MI exercises during the diabetes MNT plus MI active and maintenance intervention periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •African American
- •Clinical diagnosis of type 2 diabetes for at least 6 months
- •At risk for development and/or progression of diabetes complications (HbA1c ≥ 7.0% AND either systolic blood pressure ≥130, LDL cholesterol ≥ 100, or BMI ≥ 30).
排除标准
- •-Observed or diagnosed psychotic disorders
研究组 & 干预措施
Diabetes MNT plus MI
--Group-based dietary/dietary motivation intervention
干预措施: Diabetes MNT (Behavioral)
Diabetes MNT plus MI
--Group-based dietary/dietary motivation intervention
干预措施: Motivational Interviewing (Behavioral)
Diabetes MNT
-Group-based dietary intervention
干预措施: Diabetes MNT (Behavioral)
结局指标
主要结局
HbA1c
时间窗: Baseline
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
Change from Baseline HbA1c
时间窗: 12 months
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
Change from Baseline HbA1c
时间窗: 3 months
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
Change from Baseline HbA1c
时间窗: 6 months
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
次要结局
- LDL Cholesterol(Baseline)
- Systolic Blood Pressure(Baseline)
- Body Mass Index(Baseline)
- Change from baseline LDL Cholesterol(12 months)
- Change from Baseline Body Mass Index(12 months)
- Change from baseline Systolic Blood Pressure(12 months)
- Change from Baseline Body Mass Index(3 months)
- Change from Baseline Body Mass Index(6 months)
- Change from baseline LDL Cholesterol(3 months)
- Change from baseline LDL Cholesterol(6 months)
- Change from baseline Systolic Blood Pressure(3 months)
- Change from baseline Systolic Blood Pressure(6 months)
研究者
Stephania T. Miller-Hughes
Professor
Meharry Medical College