Effectiveness of a community-based peer lead P-MED intervention in Gestational Diabetes Mellitus (GDM) mothers of Southern state of India: A cluster randomized controlled pragmatic trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- glycemic status
研究概览
简要总结
- I) Rationale: Postpartum conversion of GDM to diabetes rate was 70% within ten years in India. Current GDM management aims to reduce the incidence of short-term adverse maternal and neonatal outcomes and not delay long-term adverse health consequences. Increased maternal weight gain and unhealthy lifestyle practices accelerate the GDM conversion to diabetes quickly. Lifestyle interventions among GDM women yielded a reduction of 24% in the incidence of T2D. No interventional studies to prevent or delay the incidence of T2D have been reported in the GDM population of southern states of India.
ii)** Novelty: Peer (from the family) based healthy lifestyle intervention rooted in psychosocial well-being, regular blood glucose monitoring, personalized nutrition plans, and physical activity schedule based on mobile technology among the GDM mothers and volunteered by ASHA workers is a unique approach in India.
iii) Objectives: Effectiveness of community-based peer-led P-MED intervention among the GDM mothers of rural areas in southern India.
iv) Method: Community-based cluster randomized controlled pragmatic trial. a) Intervention arm b) control arm. The main components of the intervention arm are psychosocial well-being, medication, regular blood glucose monitoring, Exercise, and healthy dietary options (P-MED). Development of intervention based on the COM-B (Capability, Opportunity, and Motivation -Behaviour) change model. We plan to enroll 20 PHCs (clusters) in each arm and 50 participants per PHC and in total 1000 GDM mothers/ arm.
v) Expected outcome**:** The primary outcome is to reduce the incidence of postpartum conversion of GDM into diabetes and pre-diabetes among GDM mothers.
vi) Intervention Status**:** Intervention tools, including the P-MED website (www.diabetesfreemothers.com) were developed. Intervention materials such as the GDM mother diary, ASHA modules and control booklet were prepared. Face-to-face intervention was successfully delivered to 375 GDM mothers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Participants will be ≥18 years old (adults), between 28 and 36 weeks gestation, and ready to participate in the follow-up of 48 months postnatally.
- •The last trimester of pregnancy was chosen to recruit participants as the contextual study revealed women migrated to their mother’s homes before delivery.
- •We wanted to ensure these women would be connected to health services after migration and receive postpartum follow-up.
排除标准
- •We will exclude the pregnant women if they have pre-existing diabetes mellitus, multiple pregnancies, use of medication that influences glucose metabolism (e.g., steroids, β-adrenergic agonists, and antipsychotic drugs), physical disability, or severe psychiatric disorders.
结局指标
主要结局
glycemic status
时间窗: 6 weeks ,1st year,2nd year pand 3rd year
次要结局
- Prediabetes state and impaired glycemic status(Physical activity, healthy dietary pattern)
研究者
UMA V SANKAR
Aster Medcity