Effectiveness of a digital diabetes prevention initiative in Indian cities: Hybrid type 2 pragmatic cluster-RCT using mHealth (ICMR-DPCI)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,532
- 试验地点
- 2
研究概览
简要总结
Rationale
India has more than 101 million individuals diagnosed with type 2 diabetes mellitus (T2DM). There is an urgent need to focus on preventing or delaying the onset of this condition. We propose a study, Digital-Diabetes Prevention and Control Initiative (ICMR-DPCI) a first implementation trial to evaluate the effectiveness of lifestyle modification delivered through WhatsApp (mHealth) for the prevention of diabetes among individuals with higher risk for developing diabetes within public primary health facilities of Chennai, Tamil Nadu and Jabalpur, Madya Pradesh, India.
Methods
72 primary health centres (PHCs) will be randomised to the intervention arm or control arm in Chennai and Jabalpur, India, beginning with a dual step screening for individuals aged 18 to 64 based on CBAC or IDRS scores and HbA1c levels. Participants in the control arm will receive a health education booklet detailing the symptoms, complications, and risk factors associated with T2DM, emphasising primary prevention strategies. Participants in the intervention arm receive a fully automated self-management support programme delivered twice a week for 12 months, with 100-120 messages, supported by Chatbot to motivate and support them in engaging in the behaviours needed to prevent progression to diabetes successfully. Follow-up assessments will be done at 12 months. The primary outcome is incidence of T2DM. Secondary outcomes include behavioural, clinical, quality of life and biochemical measures (HbA1c and blood lipids). An economic evaluation will also be conducted.
Expected outcome
Findings from this study will enhance policies and practices related to lifestyle modification initiatives aimed at diabetes prevention in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 64.00 Year(s)（—）
- 性别
- All
入选标准
- •Permanent residents of the selected zone.
- •Indian Diabetes Risk Score (IDRS) greater than 60 and-or Community Based Assessment Checklist (CBAC) score greater than
- •Individuals with prediabetes with HbA1c from 5.7 to 6.
- •Willingness to provide informed consent.
- •Ownership of smartphone with internet access or we will include those who can reliably access a smartphone via a family member for the intervention period.
- •Willing and able to answer calls and read multimedia messages in Tamil, Hindi, or English as part of the study.
排除标准
- •Patients with type 1 diabetes mellitus and type 2 diabetes mellitus (self-reported) for prediabetes (objective).
- •Patients with learning difficulties or vision and/or hearing impairments without a caregiver, making it impossible to use a mobile phone.
- •Malignancy or life-threatening disease with death probable in 4 years.
- •Inability or unwillingness of individual or legal guardian to give written informed consent.
- •Pregnant women.
研究者
Dr Joshua Chadwick
ICMR-National Institute of Epidemiology, Chennai