Effectiveness of Predominant Millet based Medical Nutrition Therapy on the Glycemic Control compared to the Standard Medical Nutrition Therapy among women with Gestational Diabetes Mellitus in a Tertiary Care Setting, Puducherry - An Explanatory Mixed Method Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- •Physical Activity duration (minutes per week)
研究概览
简要总结
Title: "Effectiveness of Predominant Millet based Medical Nutrition Therapy on the Glycemic Control compared to the Standard Medical Nutrition Therapy among women with Gestational Diabetes Mellitus in a Tertiary Care Setting, Puducherry – An Explanatory Mixed Method Study"
Expected outcome and Applications:
· We can assess the effectiveness of predominant millet-based medical nutrition therapy on the glycemic control in the management of GDM.
· If found effective, more emphasis can be given on predominant millet diet in MNT, since its traditional, available and affordable and it can be included in the Public Distribution System (PDS) and Anganwadi centers.
· Family support can be stressed in the GDM management.
· This ultimately improves the maternal and neonatal outcome in the pregnancy and further incorporating the healthy lifestyle after the pregnancy, reduces the morbidity among GDM mothers and their offspring later in life.
· It also helps in incorporating healthy diet practices among other household members.
- It paves way for future studies in GDM involving millets
Primary Objective: To study the effectiveness of Predominant Millet based MNT compared to standard MNT among the mothers diagnosed with GDM between 24 – 28 weeks attending antenatal clinic at JIPMER, Puducherry - on achieving glycemic goal at 2 weeks and at 1 month of follow-up
Hypothesis: What is the effect of predominant millet based medical nutrition therapy on the glycemic control among pregnant women with gestational diabetes mellitus?
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •All mothers diagnosed with GDM between 24 – 28 weeks, attending OG OPD in JIPMER, Puducherry.
排除标准
- •1.History of previous recurrent miscarriages, stillbirth 2.Pregnancy following assisted reproductive technique and Twin gestation 3.Pre-existing medical conditions (Chronic hypertension, Chronic liver disease, chronic kidney disease).
结局指标
主要结局
•Physical Activity duration (minutes per week)
时间窗: Base line, at 2 weeks and at 1 month (end line)
•Glycemic goal
时间窗: Base line, at 2 weeks and at 1 month (end line)
•Adherence to low GI diet
时间窗: Base line, at 2 weeks and at 1 month (end line)
•Adherence to predominantly millet diet
时间窗: Base line, at 2 weeks and at 1 month (end line)
次要结局
- In-depth Interview(i)Facilitator and Barriers to the adherence to predominant millet diet or Low GI diet)