Comparison of short-term outcomes of varied dietary interventions in Antenatal women of two geographically distinct Primary Health Centres
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Comparison of the weight gain between the two groups will be done
研究概览
简要总结
Primary Objectives
1. To describe the sociodemographic profile of the Antenatal women in two distinct intervention arms
2. To calculate the mean difference in weight gain in the Antenatal women in two distinct intervention arms
Secondary Objectives:
1. To assess the compliance of dietary interventions in the Antenatal women in two distinct intervention arms
Methodology
Study design: Quasi-experimental field trial
Study Duration: 2 months from the Institution Ethics Committee Approval
Study Area: Primary Health Centre, Adargunchi and Primary Health Centre, Noolvi
Study population: Antenatal mothers in II trimester
Exclusion Criteria: Antenatal mothers with high-risk pregnancy
Sample size: Assuming hypothetical mean difference in the weight gain by ANCs as .6kg at the end of two months after the intervention and with Standard Deviation as 0.8 and 0.7 respectively in the two arms, taking alpha error as .05 and Beta error as 0.02, the sample size comes out to be 25 in each arm
Study Plan:
25 ANCs will be selected purposively in PHC Adargunchi and PHC Noolvi catchment areas.
PHC Noolvi is affiliated to our institution as the Rural Health Training Centre(RHTC) and PHC Adargunchi has been adopted for the family adoption. The catchment areas of the PHCs are geographically distinct. Baseline weight of study population will be assessed before the dietary interventions. We will be giving a Health education session to all the eligible ANCs on Thursday(Weekly ANC Day at the PHCs) regarding Dietary Interventions in PHC Adargunchi. In PHC Noolvi, the eligible ANCs will be given dietary charts as per the National Institute of Nutrition Guidelines. The Dietary charts will be validated by Nutritionist of the Medical College Hospital and will be customised as per the local food habits. Weight of the study population will be done again at the end of 2 months after the intervention. Comparison of the weight gain between the two groups will be done at the end of 2 months.
Weight measurement will be done as per the WHO Guidelines using an Electronic Weighing Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Antenatal Women consenting to be a part of the study.
排除标准
- •Antenatal women with comorbid conditions like Diabetes mellitus heart diseases hypothyroidism Antenatal women with multiple pregnancies.
结局指标
主要结局
Comparison of the weight gain between the two groups will be done
时间窗: 8 weeks/ 2 months
次要结局
- To assess the compliance of dietary interventions in the Antenatal women in two distinct intervention arms(2 months)
研究者
Naman Pujeri
Jagadguru Gangadhar Mahaswamigalu Moorusavirmath Medical College
