【ChiCTR2600132897】Effectiveness of a Structured Diet and Exercise Plan on Sticking With It and Managing Cardiometabolic Health During and After Pregnancy

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基本信息

登记号

ChiCTR2600132897

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2026-09-20

临床申请受理号

靶点

适应症

Overweight and Obesity

试验通俗题目

Effectiveness of a Structured Diet and Exercise Plan on Sticking With It and Managing Cardiometabolic Health During and After Pregnancy

试验专业题目

Effectiveness of a Structured Diet and Exercise Plan on Sticking With It and Managing Cardiometabolic Health During and After Pregnancy

申办单位信息

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临床试验信息

试验目的

i. To assess the status of dietary intake, physical activity, and related weight, blood pressure, heart rate, glucose tolerance, circulating free fatty acids, and total, LDL and HDL cholesterol changes occurring during pregnancy among women with a sedentary lifestyle and/or overweight/obesity. ii. To investigate whether the provision of a structured physical activity prescription improves compliance with physical activity recommendations among women with a sedentary lifestyle and/or overweight/obesity. iii. To investigate whether the provision of a structured diet prescription improves compliance with dietary recommendations among women with a sedentary lifestyle and/or overweight/obesity. iv. To determine the effectiveness of a structured physical activity prescription in controlling weight, blood pressure, heart rate, Hb concentration, glucose tolerance, circulating free fatty acids, total, LDL and HDL cholesterol during pregnancy and their subsequent return to prepregnancy levels among women with a sedentary lifestyle and/or overweight/obesity. v. To determine the effectiveness of a structured diet prescription in controlling weight, blood pressure, heart rate, Hb concentration, glucose tolerance, circulating free fatty acids, total, LDL and HDL cholesterol during pregnancy and their subsequent return to pre-pregnancy levels among women with a sedentary lifestyle and/or overweight/obesity. vi. To assess the effects of structured diet and exercise prescriptions on pregnancy outcomes among women with a sedentary lifestyle and/or overweight/obesity.

试验分类

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试验类型

非随机对照试验

试验分期

其它

随机化

No randomization. It will be squencial sampling. All eligible at Makole health center will be assigned to experiment group while all eligible at Makole Dispensary will be asigned to comparison group.

盲法

None

试验项目经费来源

UDOM sponsorship for staff undertaking PhD studies

试验范围

目标入组人数

107

实际入组人数

第一例入组时间

2025-04-01

试验终止时间

2026-04-30

是否属于一致性

入选标准

The study will include singleton pregnant women aged 18–35 with a sedentary lifestyle and/or overweight or obese. The study will recruit only pregnant women at 6–16 weeks of gestation. The study will only include women able to give valid informed consent and willing to participate and follow the prescription. The study will include singleton pregnant women aged 18–35 with a sedentary lifestyle and/oroverweight or obese. The study will recruit only pregnant women at 6–16 weeks of gestation. The study will only include women able to give valid informed consent and willing to participateand follow the prescription.；

排除标准

Gestation below six weeks will not be included due to the difficulty of diagnosing pregnancy. Also, if gestational age was not ascertained by ultrasound examination by the end of 13 weeks of their gestation will be excluded. Potential participants with multiple pregnancies will not be included to rule out the probable multiplicity of pregnancy changes. Under–18 women will not be included to exclude the possible effects of premature reproductive systems, while those above 35 will not be included to exclude the possible effects of pregnancy at an advanced age. Women already diagnosed with cardiovascular disease or for whom exercise is contraindicated will be excluded. All potential participants will be screened for contraindications using Canadian guidelines before enrolment. To minimise the loss of follow-ups, potential participants planning to relocate out of Dodoma City during the study period will be excluded.；

研究者信息

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试验机构

University of Dodoma

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