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临床试验/NCT00617149
NCT00617149已完成1 期

Effect of Regular Exercise in Prevention of Excessive Weight Gain in Pregnancy. A Single Blind Randomized Controlled Trial

Norwegian School of Sport Sciences2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2007年11月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
105
试验地点
2
主要终点
Primary outcomes are overall weight gain during pregnancy and proportion of participants exceeding weight gain above IOM recommendations.

研究概览

简要总结

Background:

Use of variable definitions of exercise and disparate results, emphasize the need of proper randomized controlled trials examining the relationship between physical activity and weight development during pregnancy. So far, only few intervention studies aiming at weight management during pregnancy have been performed (Gray-Donald et al., 2000,Olson et al., 2004,Polley et al., 2002,Kinnunen et al., 2007). Moreover, most of these interventions have focused on how gestational weight gain may be altered through individual counselling combining diet and exercise habits, rather than supervised training. Search on PubMed revealed no randomized controlled trial where the main outcome was to investigate how the effect of supervised structured exercise may reduce the proportion of women gaining more weight than optimal. The aim of the present study is to assess whether a 12-week aerobic exercise program during pregnancy can prevent excessive gestational weight gain.

Method:

This is a single blind randomized controlled trial to evaluate the effects of a structured, supervised aerobic exercise program on weight gain stabilization in primiparous pregnant women. The aim is to include 100 women. Interested women eligible for the present study will be invited to a pre-test including interview and assessments at the university. The women are examined three times during the study period. The first visit is between 12 and 24 weeks of gestation, the second at week 36-38 and the last 8-12 week after delivery. The exercise program consists of supervised exercise for 60 minutes, performed at least 2 times per week, for 12-16 weeks. Compliance with the training protocol is controlled by the instructors and registrations in the womens personal training diary

详细描述

Background:

Data from population-based surveys and longitudinal observational studies generally support that inactive men and women have higher body weight and BMI than physically active adults (US Departmentof Health and Human Services, 1996,Williamson et al., 1993,Sherwood et al., 2000,Anderssen et al., 2007). Studies examining the impact of exercise on maternal weight gain are varied and limited. Two different meta- analysis's found no difference in maternal weight gain between exercisers and non-exercisers (Kramer, 2002,Lokey et al., 1991). In a review from 2004 it is suggested that women who exercise before pregnancy and continue to do so during pregnancy tend to weigh less and gain less weight that controls (Siega-Riz et al., 2004). A recent study of Haakstad et al (Haakstad et al., 2007) found that women who continued to exercise regularly in the 3rd trimester had significantly lower total weight gain. In addition, women reporting high exercise frequency in the 3rd trimester ( ≥ 4 times per week), the proportion exceeding IOM's weight gain recommendations was significantly lower compared to women exercising less frequently (1-3 times per week)(Haakstad et al., 2007). These results indicate that there may be a dose-respons relationship, with higher levels of exercising being more effective than moderate and low levels for the prevention of high maternal weight gain.

So far, only few intervention studies aiming at weight management during pregnancy have been performed (Gray-Donald et al., 2000,Olson et al., 2004,Polley et al., 2002,Kinnunen et al., 2007). Moreover, most of these interventions have focused on how gestational weight gain may be altered through individual counselling combining diet and exercise habits, rather than supervised training. Search on PubMed revealed no randomized controlled trial where the main outcome was to investigate how the effect of supervised structured exercise may reduce the proportion of women gaining more weight than optimal. The aim of the present study is to assess whether a 12-week aerobic exercise program during pregnancy can prevent excessive gestational weight gain.

Method:

Participants This is a single blind randomized controlled trial to evaluate the effects of a structured, supervised aerobic exercise program on weight gain stabilization in primiparous pregnant women. Participants will be recruited via health practitioners (physicians, midwifes), articles and advertisement in the newspapers, official websites for pregnant women, through flyers and word of mouth. The aim is to include 100 women. With power = 0.85 and alfa = 5%, the present study is designed to detect a standardized difference in total weight gain of 0.6. Assuming that the standard deviation of weight gain is 5 kilos, then the actual weight gain has to be ∆= 3 kilos.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Primiparous women who have not participated in a structured exercise program, including significant amounts of walking for the past six months are eligible for the trial.
  • Other inclusion criteria are ability to read, write and speak Norwegian, and to be within their first 24 weeks of pregnancy.

排除标准

  • Severe heart disease
  • Pregnancy induced hypertension
  • History of more than two miscarriages
  • Persistent bleeding after week 12 of gestation
  • Poorly controlled thyroid disease
  • Poorly controlled pre-eclampsia and/or other diseases that could interfere with participation (Artal and O'Toole, 2003)
  • In addition, all women who live to far from the university to be able to attend weekly training groups will be ineligible

结局指标

主要结局

Primary outcomes are overall weight gain during pregnancy and proportion of participants exceeding weight gain above IOM recommendations.

时间窗: week 36-38 of pregnancy

次要结局

  • Secondary outcomes are pregnancy complications, relationship between oxygen consumption, heart rate and blood lactate concentration at submaximal work loads, infant birth weight, length of labour and complications during delivery.(week 36-38 of gestation)

研究者

发起方
Norwegian School of Sport Sciences
申办方类型
Other

研究点 (2)

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