TRIAD-2 Center for Health Disparities Research: A Family-Based Diabetes Intervention for Hispanic Adults in an Emerging Community
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Hemoglobin A1C
研究概览
简要总结
The aim of this study was to compare the efficacy of an intervention and an attention control group in producing changes in diabetes self-management, glycemic control (HbA1c) and health related quality of life in Hispanics with type 2 diabetes.
Hypothesis: The experimental group who receive an 8 week intervention program would show significantly greater improvements than an attention control group at 1 and 6 months after the intervention in: behavioral influences of diabetes knowledge, diabetes self-efficacy, and family support, outcomes of self-reported management of diabetes (physical activity, diet, medications, and glucose monitoring), HbA1c levels, and psychological outcomes of health-related quality of life.
详细描述
A total of 186 participants and their family members were recruited, 103 in the experimental group and 83 in the attention control group.
An intervention consisted of eight weekly interactive modules, for a total of 12 hours, and based on modules from National Standards for Diabetes Self-Management Education, and the National Diabetes Education Program. Data were collected at baseline, immediately post-intervention, and at 3 and 6 month follow-up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for participants:
- •Community-dwelling
- •Self-identification as Hispanic
- •Age 18 years or older
- •Self-identification as having a medical diagnosis of type 2 diabetes
- •An adult family member willing to participate in the study.
- •Must be able to speak either English or Spanish
- •Inclusion criteria for family members/relatives are:
- •Family member is over 18
- •Reside in the same household as the participant with diabetes
- •Must be able to speak either English or Spanish
排除标准
- •We will exclude Hispanic adults and family members who are:
- •diagnosed with type 1 diabetes
- •report prior (within the past year) or current participation in other diabetes self-management intervention programs
- •cognitively impaired (not oriented to time, place, or person, or with known dementia)
- •Pregnant at the time of T1 (baseline) data collection
研究组 & 干预措施
Intervention group
Diabetes self-management and family support
干预措施: Diabetes self-management program for Hispanics and their families (Behavioral)
Attention control group
General health information
干预措施: General health educational program for Hispanics and their families (Behavioral)
结局指标
主要结局
Hemoglobin A1C
时间窗: Week 0 (Baseline)
Glycemic control in %.
Hemoglobin A1c
时间窗: Month 9 (6 months post-intervention)
Glycemic control
Hemoglobin A1c
时间窗: Month 3 (one month post-intervention)
Glycemic control
Hemoglobin A1c
时间窗: Month 2 (post-intervention)
Glycemic control
次要结局
- Health-related Quality of Life (SF-12)(Month 9 (6 months post-intervention))
- Health-related Quality of Life (SF-12)(Week 0 (Baseline))
- Health-related Quality of Life (SF-12)(Month 2 (post-intervention))
- Health-related Quality of Life (SF-12)(Month 3 (one month post-intervention))
研究者
Jie Hu
Principal Investigator
Ohio State University