INTER-ACT: prevention of pregnancy complications through an e-health driven interpregnancy lifestyle intervention – study protocol of a multicentre randomised controlled trial

BMC Pregnancy and Childbirth

Study Protocol

Lieveke Ameye¹  Kelly Amuli²  Margriet Bijlholt²  Roland Devlieger³  Annick Bogaerts⁴  Dorine Heynickx⁵ 

[1] Department of Development and Regeneration, KU Leuven, Herestraat 49, 3000, Leuven, Belgium;Department of Development and Regeneration, KU Leuven, Herestraat 49, 3000, Leuven, Belgium;Department of Nursing and Midwifery, CRIC Centre for Research & Innovation in Care, University of Antwerp, Universiteitsplein 1, 2610, Wilrijk, Belgium;Department of Development and Regeneration, KU Leuven, Herestraat 49, 3000, Leuven, Belgium;Department of Obstetrics, Gynecology and Reproduction, St-Augustinus Hospital Wilrijk, Oosterveldlaan 24, 2610, Wilrijk, Belgium;Department of Obstetrics and Gynecology, University Hospital Leuven, Herestraat 49, 3000, Leuven, Belgium;Department of Development and Regeneration, KU Leuven, Herestraat 49, 3000, Leuven, Belgium;Research Unit Healthy Living, Faculty of Health and Social Work, University College Limburg-Leuven, Wetenschapspark 21, 3590, Diepenbeek, Belgium;Department of Nursing and Midwifery, CRIC Centre for Research & Innovation in Care, University of Antwerp, Universiteitsplein 1, 2610, Wilrijk, Belgium;Research Unit Healthy Living, Faculty of Health and Social Work, University College Limburg-Leuven, Wetenschapspark 21, 3590, Diepenbeek, Belgium;

关键词: RCT;    Interpregnancy lifestyle intervention;    Maternal obesity;    Excessive gestational weight gain;    Pregnancy-induced hypertension;    Gestational diabetes;    Caesarean section;    Large-for-gestational-age;   

DOI  :  10.1186/s12884-017-1336-2

 received in 2017-01-16, accepted in 2017-05-19,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundExcessive maternal pre-pregnancy and gestational weight gain are related to pregnancy- and birth outcomes. The interpregnancy time window offers a unique opportunity to intervene in order to acquire a healthy lifestyle before the start of a new pregnancy.MethodsINTER-ACT is an e-health driven multicentre randomised controlled intervention trial targeting women at high risk of pregnancy- and birth related complications. Eligible women are recruited for the study at day 2 or 3 postpartum. At week 6 postpartum, participants are randomised into the intervention or control arm of the study. The intervention focuses on weight, diet, physical activity and mental well-being, and comprises face-to-face coaching, in which behavioural change techniques are central, and use of a mobile application, which is Bluetooth-connected to a weighing scale and activity tracker. The intervention is rolled out postpartum (4 coaching sessions between week 6 and month 6) and in a new pregnancy (3 coaching sessions, one in each trimester of pregnancy); the mobile app is used throughout the two intervention phases. Data collection includes data from the medical record of the participants (pregnancy outcomes and medical history), anthropometric data (height, weight, waist- and hip circumferences, skinfold thickness and body composition by bio-electrical impedance analysis), data from the mobile app (physical activity and weight; intervention group only) and questionnaires (socio-demographics, breastfeeding, food intake, physical activity, lifestyle, psychosocial factors and process evaluation). Medical record data are collected at inclusion and at delivery of the subsequent pregnancy. All other data are collected at week 6 and month 6 postpartum and every subsequent 6 months until a new pregnancy, and in every trimester in the new pregnancy. Primary outcome is the composite endpoint score of pregnancy-induced hypertension, gestational diabetes mellitus, caesarean section, and large-for-gestational-age infant in the subsequent pregnancy.DiscussionINTER-ACT is a unique randomised controlled lifestyle intervention trial in its implementation between pregnancies and during the subsequent pregnancy, with an e-health driven approach.Trial registrationClinicalTrials.gov Identifier: NCT02989142. Registered August 2016.

【 授权许可】

CC BY   
© The Author(s). 2017