Impact of Behavioural Modification Working Toolkit Among Women With Gestational Diabetes Mellitus and Hypertension: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Fasting Blood Glucose
研究概览
简要总结
This trial aims to evaluate the effectiveness of a Behavioral Modification Working (BMW) Toolkit in improving glycemic control and blood pressure among pregnant women diagnosed with both GDM and PIH.
详细描述
Gestational diabetes mellitus (GDM) and pregnancy-induced hypertension (PIH) are major contributors to maternal and neonatal morbidity, particularly in low- and middle-income countries. Evidence suggests that lifestyle and self-care interventions focusing on diet, physical activity, and sleep may improve maternal outcomes; however, rigorously designed randomized controlled trials evaluating structured behavioral toolkits in Pakistan are scarce.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the nature of the behavioral intervention, participants and care providers cannot be blinded. Outcome assessors/data analysts may be blinded where feasible.
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women aged 15-49 years.
- •Gestational age between 16 and 20 weeks at enrolment.
- •Diagnosed with both gestational diabetes mellitus (GDM) and pregnancy-induced hypertension (PIH).
- •At least one prior antenatal visit at the study site.
排除标准
- •Pre-existing diabetes mellitus or chronic hypertension prior to pregnancy.
- •Pre-existing renal disease, thyroid disease, or major hematological disorders.
- •Multiple pregnancy (e.g., twins, triplets).
- •Severe psychiatric illness.
研究组 & 干预措施
BMW Toolkit + Routine Antenatal Care
Participants receive the Behavioral Modification Working (BMW) Toolkit in addition to routine antenatal care. The intervention includes 7-8 structured sessions delivered by a trained health educator focusing on dietary modification, physical activity, sleep hygiene, and self-care practices during pregnancy.
干预措施: Behavioral Modification Working (BMW) Toolkit (Behavioral)
Routine Antenatal Care Alone
Participants receive routine antenatal care according to standard hospital practice for management of gestational diabetes mellitus and pregnancy-induced hypertension without the BMW Toolkit intervention.
干预措施: Routine Antenatal Care (Other)
结局指标
主要结局
Fasting Blood Glucose
时间窗: Baseline and 40 weeks gestation
Fasting blood glucose concentration (mg/dL or mmol/L, according to site laboratory standard) will be measured at baseline and at follow-up. The outcome measure is the change from baseline to 40 weeks gestation, compared between study groups.
Blood Pressure
时间窗: Baseline and 36 weeks gestation
Systolic and diastolic blood pressure (mmHg) measured at baseline and follow-up. Outcome is change from baseline to 36 weeks gestation compared between study groups.
次要结局
未报告次要终点
研究者
Assia Riaz
Principal Investigator
University of the Punjab