Effectiveness of a mHealth-Based Lifestyle Toolkit on Health Outcomes among Individuals with Cardiometabolic Multimorbidity: A Type 1 Hybrid Effectiveness-Implementation Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 840
- 试验地点
- 3
- 主要终点
- The primary outcome of this study is the clinical effectiveness of MultiLife, shown by the change in HbA1c from baseline to six months post-intervention, with a clinically significant reduction defined as 0.5 percentage points or greater. HbA1c levels will be measured at baseline, three months, and six months.
研究概览
简要总结
This study evaluates the effectiveness of a lifestyle toolkit delivered via mHealth channels by primary health care staff in reducing HbA1c levels, BP, and BMI among individuals with cardiometabolic multimorbidity (CMM) in India. Using a two-arm parallel group 1:1 cluster randomized controlled trial design, the intervention group receives (a digital platform, ASHA/ PHC support, and usual care) against the control group (ASHA/ PHC support and usual care). Conducted over 24 months across three cohorts in states Jharkhand( MRHRU, Namkum ) and Odisha (MRHRU, Tigiria and MRHRU, Sheragada), the "MultiLife" intervention includes a mobile app providing daily reminders for lifestyle modifications and monthly health education videos. Primary outcome measures include changes in Glycemic control, with secondary outcomes encompassing Blood Pressure(systolic and diastolic), Body mass index and Waist circumference, Quality of life, stress levels, substance usage ( tobacco & alcohol usage), adherence to drugs and physical activities. This study aims to leverage community resources and technology to reduce the CMM burden in India, potentially informing public health strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals diagnosed with CMM
- •Aged 18 to 70 years, providing informed consent for participation and expressing willingness to comply with follow-up requirements
- •Own an Android mobile phone.
排除标准
- •Patients with cognitive impairment hindering instruction-following, bedridden status, severe mental illness, ongoing cancer treatment, or those in end-of-life care, pregnancy, or individuals not planning to reside in the study area during the intervention period.
结局指标
主要结局
The primary outcome of this study is the clinical effectiveness of MultiLife, shown by the change in HbA1c from baseline to six months post-intervention, with a clinically significant reduction defined as 0.5 percentage points or greater. HbA1c levels will be measured at baseline, three months, and six months.
时间窗: Baseline (at zero month), three months, and six months.
次要结局
- Secondary Outcomes: Change in systolic and diastolic blood pressure, BMI & WC, QoL scores, dietary(patterns, tobacco and alcohol consumption, adherence to prescribed medications, level of physical activity.)
研究者
Dr Tanveer Rehman
ICMR- Regional Medical Research Centre, Bhubaneswar