A Lifestyle Change Program for Managing Diabetes Among the Marshallese in Northwest Arkansas: A Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
- 主要终点
- A1C lab measure
研究概览
简要总结
The proposed study aims to fill the gap by adapting an evidence-based intervention and conducting a pilot trial to determine the new program's estimated effect sizes on occupational resilience, A1c, and diabetes-related quality of life. Developing and adapting Lifestyle Redesign (LR) for Marshallese diabetes management is significant because it would reduce health disparities in a community that is disproportionately affected by the disease, and a large number of Marshallese (currently approximately 15,000) have resided in the northwest Arkansas region since the 1980s.
详细描述
To pilot-test AHD Program, a lifestyle change intervention for diabetes management, and obtain estimates of effect sizes on occupational resilience, A1C, and diabetes-related quality of life. It is hypothesized that occupational resilience, diabetes-related quality of life, and A1C will be improved by the end of the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Marshallese Adults
- •type 2 diabetes and test results (within 30 days) showing A1C greater than 6.4% or Estimated Average Glucose greater than 137 mg/dL.
- •Able (and willing) to participate in exercise, diet management, and group dancing.
排除标准
- •Marshallese who otherwise meet inclusion criteria but are not willing to commit to active participation in a lifestyle change intervention.
- •Comorbidities that limit participation in the specified activities (i.e., stepper exercises, dieting, and dancing).
研究组 & 干预措施
ActiveHeal Diabetes (AHD) Program - Group A
This group will continue routine care and participate in the AHD Program. AHD Program.
干预措施: ActiveHeal Diabetes (AHD) Program (Behavioral)
Standard of Care - Group B
This group will not participate in the AHD Program. The group participants will continue their routine care but will be invited to all 6 sessions on managing a healthy diet run by the EFNEP team.
结局指标
主要结局
A1C lab measure
时间窗: screening and week 15
is a blood test that measures your average blood sugar (glucose) levels over the past two to three months. It works by measuring the amount of glucose attached to hemoglobin, a protein in your red blood cells responsible for carrying oxygen.
Occupational Resilience Measure (ORM 1.0)
时间窗: At time of enrollment and week 15
a 20-item self-report assessment designed to evaluate occupational resilience, which is the capacity to persist in an occupation despite adversity
Diabetes-related quality of Life (RV-DQOL)
时间窗: At time of enrollment and week 15
The primary objective of the RV-DQoL is to measure various aspects of quality of life affected by diabetes, including: Satisfaction: Assessing patient satisfaction with different aspects of their life, including time spent managing diabetes and receiving checkups, current treatment, knowledge about diabetes, body appearance, and overall life satisfaction. Impact: Evaluating the extent to which diabetes impacts daily life, including feelings of physical illness or pain related to treatment, embarrassment related to managing diabetes in public, and interference with family life. Worry: Assessing the degree of worry related to diabetes, such as passing out due to low blood sugar, changes in body appearance, and the potential for developing complications.
次要结局
未报告次要终点