Feasibility of a controlled trial aiming to prevent excessive pregnancy-related weight gain in primary health care.
Feasibility of a controlled trial aiming to prevent excessive pregnancy-related weight gain in primary health care.
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DOI：
10.1186/1471-2393-8-37
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发表时间：
2008-08-11
影响因子：
3.1
通讯作者：
Luoto, Riitta
中科院分区：
文献类型：
--
作者：
Kinnunen, Tarja I;Aittasalo, Minna;Luoto, Riitta
背景：妊娠期体重过度增加和产后体重保持可能使妇女易患长期超重和其他健康问题。需要进行干预研究，以防止与怀孕有关的体重过度增加。在这个试点study.METHODS：一个非随机对照试验进行了三个干预和三个控制妇幼保健诊所在芬兰的初级卫生保健实施这样的研究协议的可行性进行了评估。共有132名孕妇和92名产后妇女以及23名公共卫生护士（PHN）参加了这项研究。干预措施包括对PHN进行五次常规访视时进行的体力活动和饮食方面的个人咨询，以及在妊娠37周或产后10个月之前进行监督性团体锻炼的选择。对照诊所继续进行常规护理。结果：（1）招募速度慢于预期，招募周期由原计划的3个月延长至6个月;符合条件的妇女在研究登记时的平均参与率为77%，辍学率为15%。2)总的来说，获得了99%的体重、体力活动和饮食数据以及96%的血液样本。3)在干预诊所中，98%的咨询会议得以实现，其内容和平均持续时间与预期一致，87%的参与者定期完成每周体力活动和饮食记录，团体锻炼会议的平均参与率为45%。4)PHN认为额外的培训作为一个主要的优势和高额外的工作量作为一个缺点的study.CONCLUSION：该研究方案大多是可行的实施，这鼓励进行大型试验在可比settings.TRIAL注册：当前对照试验ISRCTN 21512277。
BACKGROUND: Excessive gestational weight gain and postpartum weight retention may predispose women to long-term overweight and other health problems. Intervention studies aiming at preventing excessive pregnancy-related weight gain are needed. The feasibility of implementing such a study protocol in primary health care setting was evaluated in this pilot study.METHODS: A non-randomized controlled trial was conducted in three intervention and three control maternity and child health clinics in primary health care in Finland. Altogether, 132 pregnant and 92 postpartum women and 23 public health nurses (PHN) participated in the study. The intervention consisted of individual counselling on physical activity and diet at five routine visits to a PHN and of an option for supervised group exercise until 37 weeks' gestation or ten months postpartum. The control clinics continued their usual care. The components of the feasibility evaluation were 1) recruitment and participation, 2) completion of data collection, 3) realization of the intervention and 4) the public health nurses' experiences.RESULTS: 1) The recruitment rate was slower than expected and the recruitment period had to be prolonged from the initially planned three months to six months. The average participation rate of eligible women at study enrollment was 77% and the drop-out rate 15%. 2) In total, 99% of the data on weight, physical activity and diet and 96% of the blood samples were obtained. 3) In the intervention clinics, 98% of the counselling sessions were realized, their contents and average durations were as intended, 87% of participants regularly completed the weekly records for physical activity and diet, and the average participation percentage in the group exercise sessions was 45%. 4) The PHNs regarded the extra training as a major advantage and the high additional workload as a disadvantage of the study.CONCLUSION: The study protocol was mostly feasible to implement, which encourages conducting large trials in comparable settings.TRIAL REGISTRATION: Current Controlled Trials ISRCTN21512277.