mHealth Lifestyle Management Program (LIVEN) For Adults With Diabetes Type 2: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- recruitment rate - descriptive
研究概览
简要总结
This study will evaluate whether the 12-week health coaching mobile application (LIVEN) will succeed in enhancing lifestyle behaviors in adults with Type 2 Diabetes compared to typical treatment. The mobile application's viability will be assessed in 2 parts; the first part is testing easiness and friendliness of using Liven by the patient and health coach. The second part is evaluating the suitability of Liven education material for the patients and whether the coaching program results in enhancing lifestyle behaviors and blood sugar levels. the investigators hypothesize that the 12-week online lifestyle-coaching program will be viable, and a full-scale study can proceed.
详细描述
This study will investigate the feasibility of a 12-weeks online lifestyle (nutrition and physical behavior) coaching program through a mobile app (LIVEN) compared to standard treatment for people with type 2 diabetes. This study will be done in two phases; the first phase is the usability study (phase1), in which the user friendliness of the application will be assessed, and any technical flaws will be resolved prior and during the second phase. The second phase of the study will consist of adapting a diabetes educational material and assessing the feasibility of the program (phase2). the investigators hypothesize that the 12-week online lifestyle-coaching program will be feasible, and a full-scale study can proceed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The participant won't know if they got the full or sham or no intervention
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
- •Adults, aged 18 years or older
- •Arabic speakers
- •Capable of utilizing smartphones
- •Diagnosed with T2DM
- •Poor glycemic control: A1c > 7.5%
排除标准
- •Individuals using insulin injection
- •Individuals suffering from disorders that might affect intervention (e.g. amputation, enucleation of the eye, or end-stage kidney disease)
- •Women who are pregnant or breastfeeding
- •Individuals diagnosed with other types of diabetes (such as type I or MODY)
结局指标
主要结局
recruitment rate - descriptive
时间窗: immediately after the intervention (3 months)
reported as the number of participants' consented divide by the number of people that were invited to participate
retention rates
时间窗: immediately after the intervention (3 months)
reported as the number of participants completing all study sessions
User friendliness
时间窗: Daily application engagement data for each patient will be analyzed once at the end of the patient's 12 week program.
will be assessed via user engagement tracking in the app
次要结局
- Glycemic control - A1c(will be assessed one week prior to the intervention and one week after the end of the intervention)
- Glycemic control - continuous glucose mentoring (CGM)(will be assessed one week prior to the intervention and one week after the end of the intervention)
- Lifestyle behaviors - Health-Promoting Lifestyle profile II (Questionnaire)(will be assessed one week prior to the intervention and one week after the end of the intervention)
- physical performance assessments - upper body muscle strength in kg(will be assessed one week prior to the intervention and one week after the end of the intervention)
- physical performance assessments - lower body muscle strength in counts(will be assessed one week prior to the intervention and one week after the end of the intervention)
- Body composition - fat free mass (%) physiological parameter(will be assessed one week prior to the intervention and one week after the end of the intervention)
- physical performance assessments - endurance(will be assessed one week prior to the intervention and one week after the end of the intervention)
研究者
Shaima Alothman
Research Scientist, Clinical Assistant Professor
Princess Nourah Bint Abdulrahman University