Medical Nutrition Therapy and Diabetes Self-Management Education for People With Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Psychological Distress
研究概览
简要总结
The purpose of this project is to develop, and pilot test an accessible and inclusive medical nutrition therapy and diabetes self-management education program for people with Type 2 Diabetes and physical disabilities.
详细描述
This study will use a three-arm randomized control trial design. Eligible and consented participants will be assigned to one of three groups: (1) intervention with high-tech support, (2) intervention with low-tech support, and (3) attention-control group. The active intervention period will include six months of weekly health coaching calls and technology access. The low-tech support group will receive six months of weekly coaching calls and weekly email containing related materials in PDF format but no video and technology content.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of T2DM
- •18 to 65 years of age
- •Living with a permanent physical disability such as SCI, spina bifida, multiple sclerosis, stroke
- •Ability to converse in and read English
- •Availability of a smartphone or computer that can run apps
- •Have internet connection capabilities
排除标准
- •Current enrollment in any diabetes related intervention
- •Present or soon-planned pregnancy
- •Major heart attack or heart surgery in the past 12 months
- •Have undergone a dialysis, kidney transplant or a kidney surgery in the past 12 months
- •Severe cognitive impairment
- •Severe untreated depression in the past 6 months
研究组 & 干预措施
Experimental: High-Tech Intervention Group
Those in the high-tech intervention group will receive 6 months of active intervention (up to 60 minutes weekly health coaching calls and content delivery) and technology access.
干预措施: High-Tech (Behavioral)
Experimental: Low-Tech Intervention Group
Those in low-tech group will receive 6 months of one weekly coaching calls (last up to 60 minutes) and one weekly email
干预措施: Low-Tech (Behavioral)
Active Comparator: Attention Control Group
The control group will be used to provide an untreated comparison for the intervention groups and will not receive MNT or technology support. Participants in the control arm will only get a baseline and post-intervention testing.
干预措施: Attention Control (Behavioral)
结局指标
主要结局
Psychological Distress
时间窗: 234 weeks
Measured using Diabetes Distress Scale (DDS); Minimum score = 1, maximum score = 6; Higher score represents worse outcome
Diabetes Quality of Life
时间窗: 24 weeks
Measured using the DQoL (Diabetes Quality of Life Measure) Questionnaire; Minimum score =1; maximum score = 5; Higher score represents worse outcome
Self-efficacy
时间窗: 24 weeks
Measured using Diabetes Empowerment Scale; Minimum score = 1; maximum score = 5; Higher score represents better outcome
次要结局
- Glycemic Management(24 weeks)
研究者
Mohanraj Thirumalai
Assistant Professor
University of Alabama at Birmingham