Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Annick Bogaerts, Lieveke Ameye, Margriet Bijlholt, Kelly Amuli, Dorine Heynickx, Roland Devlieger

Published in: BMC Pregnancy and Childbirth | Issue 1/2017

Login to get access

Abstract

Background

Excessive 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.

Methods

INTER-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.

Discussion

INTER-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 registration

ClinicalTrials.gov Identifier: NCT02989142. Registered August 2016.
Literature
1.
Poston L, Caleyachetty R, Cnattingius S, Corvalán C, Uauy R, Herring S, et al. Preconceptional and maternal obesity: epidemiology and health consequences. Lancet Diabetes Endocrinol. 2016;4(12):1025–36.PubMedCrossRef
2.
Poobalan A, Aucott L, Gurung T, Smith WCS, Bhattacharya S. Obesity as an independent risk factor for elective and emergency caesarean delivery in nulliparous women–systematic review and meta‐analysis of cohort studies. Obes Rev. 2009;10(1):28–35.PubMedCrossRef
3.
Chu SY, Callaghan WM, Kim SY, Schmid CH, Lau J, England LJ, et al. Maternal obesity and risk of gestational diabetes mellitus. Diabetes Care. 2007;30(8):2070–6.PubMedCrossRef
4.
Catalano P, Ehrenberg H. Review article: The short‐and long‐term implications of maternal obesity on the mother and her offspring. BJOG. 2006;113(10):1126–33.PubMedCrossRef
5.
Rasmussen KM, Yaktine AL. Weight gain during pregnancy: reexamining the guidelines. Washington, DC: National Academies Press; 2010.
6.
7.
Chung JG, Taylor RS, Thompson JM, Anderson NH, Dekker GA, Kenny LC, et al. Gestational weight gain and adverse pregnancy outcomes in a nulliparous cohort. Eur J Obstet Gynecol Reprod Biol. 2013;167(2):149–53.PubMedCrossRef
8.
Ferraro ZM, Barrowman N, Prud’homme D, Walker M, Wen SW, Rodger M, et al. Excessive gestational weight gain predicts large for gestational age neonates independent of maternal body mass index. J Matern Fetal Neonatal Med. 2012;25(5):538–42.PubMedCrossRef
9.
Haugen M, Brantsæter AL, Winkvist A, Lissner L, Alexander J, Oftedal B, et al. Associations of pre-pregnancy body mass index and gestational weight gain with pregnancy outcome and postpartum weight retention: a prospective observational cohort study. BMC Pregnancy Childbirth. 2014;14(1):201.PubMedPubMedCentralCrossRef
10.
Xiong C, Zhou A, Cao Z, Zhang Y, Qiu L, Yao C, et al. Association of pre-pregnancy body mass index, gestational weight gain with cesarean section in term deliveries of China. Scientific Reports. 2016;6:37168.PubMedPubMedCentralCrossRef
11.
Bogaerts A, Van den Bergh B, Nuyts E, Martens E, Witters I, Devlieger R. Socio-demographic and obstetrical correlates of pre-pregnancy body mass index and gestational weight gain. Clin Obes. 2012;2(5–6):150–9.PubMedCrossRef
12.
Bogaerts A, Van den Bergh BR, Ameye L, Witters I, Martens E, Timmerman D, et al. Interpregnancy weight change and risk for adverse perinatal outcome. Obstet Gynecol. 2013;122(5):999–1009.PubMedCrossRef
13.
Endres LK, Straub H, McKinney C, Plunkett B, Minkovitz CS, Schetter CD, et al. Postpartum Weight Retention Risk Factors and Relationship to Obesity at One Year. Obstet Gynecol. 2015;125(1):144–52.PubMedPubMedCentralCrossRef
14.
Rooney BL, Schauberger CW, Mathiason MA. Impact of perinatal weight change on long-term obesity and obesity-related illnesses. Obstet Gynecol. 2005;106(6):1349–56.PubMedCrossRef
15.
Kirkegaard H, Stovring H, Rasmussen KM, Abrams B, Sorensen TI, Nohr EA. How do pregnancy-related weight changes and breastfeeding relate to maternal weight and BMI-adjusted waist circumference 7 y after delivery? Results from a path analysis. Am J Clin Nutr. 2014;99(2):312–9.PubMedCrossRef
16.
Mongraw-Chaffin ML, Anderson CA, Clark JM, Bennett WL. Prepregnancy body mass index and cardiovascular disease mortality: the Child Health and Development Studies. Obesity (Silver Spring). 2014;22(4):1149–56.CrossRef
17.
Liu H, Zhang C, Zhang S, Wang L, Leng J, Liu D, et al. Prepregnancy body mass index and weight change on postpartum diabetes risk among gestational diabetes women. Obesity (Silver Spring). 2014;22(6):1560–7.CrossRef
18.
Troesch B, Biesalski HK, Bos R, Buskens E, Calder PC, Saris WH, et al. Increased intake of foods with high nutrient density can help to break the intergenerational cycle of malnutrition and obesity. Nutrients. 2015;7(7):6016–37.PubMedPubMedCentralCrossRef
19.
20.
Hanson M, Barker M, Dodd JM, Kumanyika S, Norris S, Steegers E, et al. Interventions to prevent maternal obesity before conception, during pregnancy, and post partum. Lancet Diabetes Endocrinol. 2016;5(1):65–76.
21.
Dodd JM, Turnbull D, McPhee AJ, Deussen AR, Grivell RM, Yelland LN, et al. Antenatal lifestyle advice for women who are overweight or obese: LIMIT randomised trial. BMJ. 2014;348:g1285.PubMedPubMedCentralCrossRef
22.
Poston L, Bell R, Croker H, Flynn AC, Godfrey KM, Goff L, et al. Effect of a behavioural intervention in obese pregnant women (the UPBEAT study): a multicentre, randomised controlled trial. Lancet Diabetes Endocrinol. 2015;3(10):767–77.PubMedCrossRef
23.
Barker M, Baird J, Lawrence W, Vogel C, Stömmer S, Rose T, et al. Preconception and pregnancy: opportunities to intervene to improve women’s diets and lifestyles. J Dev Orig Health Dis. 2016;7(03):330–3.CrossRef
24.
Hadar E, Ashwal E, Hod M. The preconceptional period as an opportunity for prediction and prevention of noncommunicable disease. Best Pract Res Clin Obstet Gynaecol. 2015;29(1):54–62.PubMedCrossRef
25.
Witkop CT. Preconception and Pregnancy Care in Overweight or Obese Woman. In: Obesity During Pregnancy in Clinical Practice. London: Springer; 2014. p. 33–52.
26.
Dean SV, Lassi ZS, Imam AM, Bhutta ZA. Preconception care: nutritional risks and interventions. Reprod Health. 2014;11(3):1.CrossRef
27.
28.
Choi J, Fukuoka Y, Lee JH. The effects of physical activity and physical activity plus diet interventions on body weight in overweight or obese women who are pregnant or in postpartum: a systematic review and meta-analysis of randomized controlled trials. Prev Med. 2013;56(6):351–64.PubMedPubMedCentralCrossRef
29.
Lim S, O’Reilly S, Behrens H, Skinner T, Ellis I, Dunbar J. Effective strategies for weight loss in post‐partum women: a systematic review and meta‐analysis. Obes Rev. 2015;16(11):972–87.PubMedCrossRef
30.
Nascimento S, Pudwell J, Surita F, Adamo K, Smith G. The effect of physical exercise strategies on weight loss in postpartum women: a systematic review and meta-analysis. Int J Obes. 2014;38(5):626–35.CrossRef
31.
Abraham C, Michie S. A taxonomy of behavior change techniques used in interventions. Health Psychol. 2008;27(3):379.PubMedCrossRef
32.
Bardus M, van Beurden SB, Smith JR, Abraham C. A review and content analysis of engagement, functionality, aesthetics, information quality, and change techniques in the most popular commercial apps for weight management. Int J Behav Nutr Phys Act. 2016;13(1):1.CrossRef
33.
Lyzwinski LN. A systematic review and meta-analysis of mobile devices and weight loss with an intervention content analysis. J Personalized Med. 2014;4(3):311–85.CrossRef
34.
Schildknechtstraat G, Vanhauwaert E. De actieve voedingsdriehoek: een praktische voedings-en beweeggids. 2012.
35.
Obstetricians ACo, Gynecologists. Hypertension in pregnancy. Report of the American college of obstetricians and gynecologists’ task force on hypertension in pregnancy. Obstet Gynecol. 2013;122(5):1122.
36.
American Diabetes Association. tandards of medical care in diabetes--2014. Diabetes Care. 2014;37:S14.CrossRef
37.
Benhalima K. The VDV-VVOG-Domus Medica consensus 2012 on screening for pregestational diabetes in pregnancy and screening for gestational diabetes. P Belg Roy Acad Med. 2013;2:24–42.
38.
Devlieger H, Martens G, Bekaert A, Eeckels R. Standaarden van geboortegewicht voor zwangerschapsduur voor de Vlaamse boreling. Tijdschr Geneesk. 2000;56:1–14.CrossRef
39.
Guelinckx I, Devlieger R, Bogaerts A, Pauwels S, Vansant G. The effect of pre-pregnancy BMI on intention, initiation and duration of breast-feeding. Public Health Nutr. 2012;15(5):840–8.PubMedCrossRef
40.
Matthys C, Meulemans A, Van Der Schueren B, editors. Development and validation of general FFQ for use in clinical practice. Ann Nutr Metab; 2015: Krager.
41.
Ainsworth BE, Sternfeld B, Richardson MT, Jackson K. Evaluation of the kaiser physical activity survey in women. Med Sci Sports Exerc. 2000;32(7):1327–38.PubMedCrossRef
42.
Schmidt MD, Freedson PS, Pekow P, Roberts D, Sternfeld B, Chasan-Taber L. Validation of the Kaiser Physical Activity Survey in pregnant women. Med Sci Sports Exerc. 2006;38(1):42–50.PubMedCrossRef
43.
Jelsma JG, van Poppel MN, Galjaard S, Desoye G, Corcoy R, Devlieger R, et al. DALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial–study protocol. BMC Pregnancy Childbirth. 2013;13(1):1.CrossRef
44.
van der Bij AK, de Weerd S, Cikot RJ, Steegers EA, Braspenning JC. Validation of the dutch short form of the state scale of the Spielberger State-Trait Anxiety Inventory: considerations for usage in screening outcomes. Community Genet. 2003;6(2):84–7.PubMed
45.
Bayrampour H, McDonald S, Fung T, Tough S. Reliability and validity of three shortened versions of the State Anxiety Inventory scale during the perinatal period. J Psychosom Obstet Gynaecol. 2014;35(3):101–7.PubMedCrossRef
46.
Murray L, Carothers AD. The validation of the Edinburgh Post-natal Depression Scale on a community sample. Br J Psychiatry. 1990;157:288–90.PubMedCrossRef
47.
Bergink V, Kooistra L, Lambregtse-van den Berg MP, Wijnen H, Bunevicius R, van Baar A, et al. Validation of the Edinburgh Depression Scale during pregnancy. J Psychosom Res. 2011;70(4):385–9.PubMedCrossRef
48.
Bogaerts AF, Devlieger R, Nuyts E, Witters I, Gyselaers W, Guelinckx I, et al. Anxiety and depressed mood in obese pregnant women: a prospective controlled cohort study. Obes Facts. 2013;6(2):152–64.PubMedCrossRef
49.
50.
Antonovsky A. The structure and properties of the sense of coherence scale. Soc Sci Med. 1993;36(6):725–33.PubMedCrossRef
51.
Linden K, Sparud-Lundin C, Adolfsson A, Berg M. Well-Being and Diabetes Management in Early Pregnant Women with Type 1 Diabetes Mellitus. Int J Environ Res Public Health. 2016;13(8):836.PubMedCentralCrossRef
52.
Moons P, Budts W, De Geest S. Critique on the conceptualisation of quality of life: a review and evaluation of different conceptual approaches. Int J Nurs Stud. 2006;43(7):891–901.PubMedCrossRef
53.
Brooke J. SUS: a “quick and dirty” usability scale. In: Jordan PW, Thomas B, Weerdmeester BA, McClelland AL, editors. Usability Evaluation in Industry. London: Taylor and Francis; 1996.
54.
Metadata
Title
INTER-ACT: prevention of pregnancy complications through an e-health driven interpregnancy lifestyle intervention – study protocol of a multicentre randomised controlled trial
Authors
Annick Bogaerts
Lieveke Ameye
Margriet Bijlholt
Kelly Amuli
Dorine Heynickx
Roland Devlieger
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2017
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/s12884-017-1336-2

Other articles of this Issue 1/2017

BMC Pregnancy and Childbirth 1/2017 Go to the issue

Research article

Caesarean deliveries in China

Research article

Quality of Midwife-provided Intrapartum Care in Amhara Regional State, Ethiopia

Research article

Changing times? Gender roles and relationships in maternal, newborn and child health in Malawi

Erratum

Erratum to: Quality and uptake of antenatal and postnatal care in Haiti

Research article

Perinatal outcomes of hypertensive disorders in pregnancy at a tertiary hospital in Ghana

Research article

Maternal characteristics and obstetrical complications impact neonatal outcomes in Indonesia: a prospective study