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临床试验/NCT06241144
NCT06241144招募中不适用

Information and Communication Technology -Based Health Behavior Change Support System to Modify Lifestyle After Delivery: Randomized Controlled Intervention Study

Oulu University Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年2月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
Weight change

研究概览

简要总结

Use of information and communication technology -based health behavior change support system in modifying lifestyle after delivery among women with obesity.

详细描述

Postpartum weight retention is common and particular when accompanied with prior obesity, it further increases the risks of subsequent pregnancies and adverse effects on the long-term health.

The aim of this randomized controlled trial is to examine whether using an information and communication technology (ICT) -based health behavior change support system (HBCSS) reduce postpartum weight retention and disorders related to subsequent pregnancy. Web-based HBCSS application utilizes persuasive design and cognitive behavioral therapy.

200 participants with prepregnancy obesity (BMI ≥ 30.0 kg/m^2) and age ≥ 18 years are randomly assigned into two groups after delivery in the Oulu university hospital. The study period begins 5-12 weeks after delivery. All participants will have conventional postpartum lifestyle counselling and the intervention group get in addition access for 12 months to web-based HBCSS application, which is recommended to use twice a week for 5-10 minutes.

Participants are followed by questionnaires up to 24 months. The main outcome is weight change from baseline to 12 and 24 months. Medical records and national registers are used for long-term follow-up. Researchers have permission to contact participants afterwards. The ethical approval is permitted by the Regional Medical Research Ethics Committee of the Wellbeing Services County of North Ostrobothnia. The authorization for the use of medical device is granted from the Finnish Medicines Agency. Recruitment of the participants will be performed 2/2024-1/2026.

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pre-pregnancy BMI ≥ 30.0 kg/m^2
  • Smartphone user

排除标准

  • Eating disorder
  • Severe mental disorder
  • Use of other lifestyle support system or medication
  • Non-Finnish speaker

结局指标

主要结局

Weight change

时间窗: 24 months

Weight change in kilograms and change of body mass index (kg/m\^2)

次要结局

  • Neonatal outcome in subsequent pregnancy (preterm birth, large for gestational age, small for gestational age, need for neonatal intensive care, mortality)(1-8 years)
  • Weight change before subsequent pregnancy(1-8 years)
  • Pregnancy disorders in subsequent pregnancy (gestational diabetes, pre-eclampsia, gestational hypertension, preterm delivery)(1-8 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marja Vääräsmäki

Professor

Oulu University Hospital

研究点 (2)

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