Evaluating Wearable-supported Exercise Interventions for Reducing Postpartum Weight: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Weight change at the end of the intervention at 10 weeks postpartum
研究概览
简要总结
The aim of this study is to examine the effect of walking exercise in postpartum women and to evaluate the weight management intervention by using step tracker. The following hypotheses will be tested:
- The intervention in postpartum women would reduce the retention of weight gained during pregnancy and lower the risk factors of chronic disease.
- Step tracker is an effective tool in encouraging the postpartum women to do more physical activity.
- Higher physical activity is recommended for postpartum women for healthy weight lost.
详细描述
Postpartum is an important phase in the reproductive years of women. Weight retention after childbirth can lead to chronic diseases (CD), including obesity, cardiovascular disease and other metabolic related diseases such as diabetes or high blood pressure. There are some studies suggesting that pedometer is useful to encourage women in increasing their physical activity.
We propose to evaluate the effects of physical activity intervention based on wearable steps tracker and optimal weight loss for postpartum women. It will be a pilot stratified randomized intervention study on 200 postpartum women at KK Women's and Children's Hospital. Women who are above 21 years old and had given birth between 6 weeks and 6 months before will be recruited under the study. Postpartum women who physically fit to participate in moderate intensity walking are eligible to participate in the study. Women who participated in other weight management or physical activity intervention projects will be excluded from the study. Study enrolment will be done at the Specialist Outpatient Clinics for postnatal check-ups.
This was 12-16 weeks randomized, single-center, unblinded intervention study (Figure 1). Participants were allocated in a 1:1 ratio to either the intervention group (Actigraphy watch) or the control group (no Actigraphy watch). All participants received the standard routine postpartum care, physical activity counselling with advice on walking and motivational messages. Randomization was done using sealed envelopes. Eligible participants had baseline measurements taken during the study enrolment and consent taking where anthropometric measurements, and blood samples were collected and various questionnaires were filled out to assess baseline demographics and lifestyle characteristics.
All the participants in the intervention group received an Actigraphy watch to wear all the time except for swimming and showering. Walking advises and motivational text messages will be sent to the study participants by the research team.
Data will be collected through questionnaires and clinical measurements. The questionnaires include socio-economic factors, and self-reported physical activity. Bio-physical measurements will be obtained from anthropometric measurements of participants, are collected from the participants at their follow-up time points. Objective physical activity will be collected using an Actigraphy watch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Above 21 years old
- •Viable singleton pregnancies
- •Physically fit to participate in moderate intensity walking.
- •Term pregnancy without any sever pregnancy complications. -
排除标准
- •1. Blood-borne disease patients (e.g. HIV, hepatitis B & C)
- •Participated in other weight management or physical activity intervention projects.
研究组 & 干预措施
Actigraphy watch intervention
All the participants in the intervention group received an Actigraphy watch to wear all the time except for swimming and showering. Walking advises and motivational text messages will be sent to the study participants by the research team.
干预措施: Actigraphy watch intervention (Device)
Standard care group
Walking advises and motivational text messages will be sent to the study participants by the research team.
结局指标
主要结局
Weight change at the end of the intervention at 10 weeks postpartum
时间窗: At 8-12 weeks postpartum from baseline (4-8 weeks postpartum)
Using measured weight in kgs
Weight change at the end of the intervention at 14 weeks postpartum
时间窗: At 12 to 16 weeks postpartum from baseline ( 4-8 weeks postpartum)
Using measured weight in kgs
次要结局
- Change in glucose homeostasis markers from baseline at 10 weeks and 14 weeks postpartum(Baseline, 10 weeks (8-12 weeks postpartum), and 14 weeks (12-16 weeks postpartum))
- Change in blood pressure from baseline at 10 weeks and 14 weeks postpartum(At baseline, 10 weeks (8-12 weeks postpartum) and 14 weeks (12-16 weeks postpartum))
- Change in body mass index measures from baseline, 10 weeks postpartum and 14 weeks postpartum(Baseline (4-8 weeks postpartum), 10 weeks postpartum ( 8-12 weeks postpartum) and 14 weeks postpartum (12-16 weeks postpartum))
- Change in waist circumference measures from baseline, 10 weeks postpartum and 14 weeks postpartum(Baseline (4-8 weeks postpartum), 10 weeks (8-12 weeks postpartum) and 14 weeks (12-16 weeks postpartum))
- Change in waist to hip ratio from baseline, 10 weeks and 14 weeks postpartum(Baseline 6 weeks postpartum (4-8 weeks postpartum), 10 weeks postpartum (8-12 weeks postpartum) and 14 weeks postpartum (12-16 weeks postpartum).)
- Change in body fat mass from baseline, 10 and 14 weeks postpartum(Baseline, 10 weeks postpartum (8-12 weeks postpartum) and 14 weeks (12-16 weeks postpartum))
- Change in fasting lipid profile from baseline, 10 weeks and 14 weeks postpartum(Baseline, 10 weeks (8-12 week postpartum) and 14 weeks (12-16 weeks postpartum))
- Change in glucose homeostasis markers from baseline at 10 weeks and 14 weeks postpartum(Baseline, 10 weeks (8-12 weeks postpartum), and 14 weeks (12-16 weeks postpartum))
- Change in blood pressure from baseline at 10 weeks and 14 weeks postpartum(At baseline, 10 weeks (8-12 weeks postpartum) and 14 weeks (12-16 weeks postpartum))
- Change in self-reported frequency of moderate to vigorous physical activity at baseline, 10 weeks and 14 weeks(At baseline, 10 weeks (8-12 weeks postpartum) and 14 weeks (12-16 weeks postpartum).)
- Change in self-reported duration of moderate to vigorous physical activity at baseline, 10 weeks and 14 weeks(At baseline, 10 weeks (8-12 weeks postpartum) and 14 weeks (12-16 weeks postpartum).)
- Change in duration of objective moderate to vigorous physical activity at baseline, 10 weeks and 14 weeks(Baseline, 10 weeks postpartum (8-12 weeks postpartum) and 14 weeks (12-16 weeks).)
- Change in frequency of objective moderate to vigorous physical activity at baseline, 10 weeks and 14 weeks(Baseline, 10 weeks postpartum (8-12 weeks postpartum) and 14 weeks (12-16 weeks).)
研究者
Bernard Chern Su Min
Head ＆ Senior Consultant
KK Women's and Children's Hospital