Welcome
Support Centre
24 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
An intervention aimed at the prevention of excessive weight gain during pregnancy
ISRCTN ISRCTN85313483
DOI 10.1186/ISRCTN85313483
ClinicalTrials.gov identifier
EudraCT number
Public title An intervention aimed at the prevention of excessive weight gain during pregnancy
Scientific title
Acronym New Life(style)
Serial number at source NTR32
Study hypothesis Weight gain during pregnancy is the most important determinant of postpartum weight retention. In this study, the effect of an individually tailored intervention program is assessed on weight gain during pregnancy. The main focus of this program is to help women to gain weight within guidelines for weight development during pregnancy, which are developed by the Institute of Medicine (IOM). We expect that gaining weight within the guidelines has a positive effect on weight retention postpartum.
Lay summary Not provided at time of registration
Ethics approval The Medical Ethics Committee of VU University Medical Centre has approved the study design, protocols and informed consent procedure.
Study design Randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Weight-gain during pregnancy
Participants - inclusion criteria 1. Healthy women who are approximately seven months pregnant with their first child (nullipara)
2. Visit the midwife within 14 weeks after the start of their last menstrual period
3. Pregnant for the first time
Participants - exclusion criteria 1. Those who are directly referred to a gynaecologist because of complications
2. Unable to read/write or communicate in Dutch
Anticipated start date 01/01/2005
Anticipated end date 31/12/2007
Status of trial Completed
Patient information material
Target number of participants 300 (150 in each group)
Interventions The women will be randomly assigned to either the control group or the intervention group, and the women in the intervention group will receive advice on physical activity and diet during and after pregnancy.
Primary outcome measure(s) An assistant will perform the anthropometrical measurements and collect the blood samples at 15, 25 and 35 weeks of pregnancy and at 7, 25 and 51 weeks after delivery in the midwife practice to measure the following outcome measures:
1. Weight and body mass index (BMI) change
2. Height, measured in bare feet with a portable height scale with a wide measuring slide and a heel plate

Both weight and height will be measured twice, and the mean value of the two measurements will be computed. Calibrated scales are used to determine weight while participants are only wearing light clothing (e.g. underwear) and no shoes.
Secondary outcome measure(s) 1. Percentage body fat (sum of four skinfolds): a Harpenden calliper is used to assess percentage body fat. Percentage body fat is determined by measuring the sum of the thickness of four skinfolds: biceps, triceps, subscapular and suprailiac according to the method described by Weiner and Lourie. During pregnancy the suprailliac skinfold measurement won't be executed. Therefore, the thigh skinfold is also measured on all occasions. All skinfolds will be assessed twice. A mean value of the two will be computed. In case the two measurements of a skinfold differ more than 10%, the skinfold will be measured a third time. Also the circumference of arm and thigh will be measured.
2. Change in physical activity and dietary intake: physical activity will be assessed with the Short Questionnaire to Assess Health enhancing physical activity (SQUASH). At 15 and 35 weeks of pregnancy and 26 weeks after delivery all participants will wear an (blinded) accelerometer for three consecutive days to gather additional data on the levels of physical activity. The focus of dietary intake will be on fat, fruit and vegetable intake. These questionnaires have been validated.
3. Blood samples: in order to study the influence of lifestyle factors on energy homeostasis and weight gain, blood samples will be taken from the participants. Women will be asked for blood samples at 15, 25 and 35 weeks of pregnancy and at seven, 25 and 51 weeks after delivery. If women refuse, they can still join the study. The midwives will take a blood sample from the umbilical cord. Collecting blood for routine test and the study will be combined as much as possible in order to limit the number of venapunctures for the participants. Blood levels of leptin, ghrelin, fasting insulin/glucose, insulin growth factor one, insulin growth factor binding protein one and three, and cortisol will be measured. Analyses will take place at the laboratory of the VU University Medical Centre.
4. Data (questionnaires) will also be collected on: perceived health, stage of change (for weight management, physical activity and diet according to the model of Prochaska), self efficacy (concerning weight management, physical activity and eating habits), the duration and complications of labour, and complications during pregnancy such as gestational diabetes, pre-eclampsia, pregnancy related hypertension, pelvic pain. Possible confounders that will also be assessed by questionnaires include smoking behaviour, certain demographics (age [at menarche], education, family income, ethnicity, marital status, etc) and health conditions.
Sources of funding The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: project 4010.0017)
Trial website
Publications 1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16800869
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23121074
Contact name Dr  Mireille NM  van Poppel
  Address Afdeling Sociale Geneeskunde/EMGO Instituut
Van der Boechorststraat 7
  City/town Amsterdam
  Zip/Postcode 1081 BT
  Country Netherlands
  Tel +31 (0)20 444 82 03
  Fax +31 (0)20 444 83 87
  Email mnm.vanpoppel@vumc.nl
Sponsor Netherlands Organisation for Health Research and Development (ZonMw)
  Address Laan van Nieuw Oost Indië 334
PO Box 93 245
  City/town The Hague
  Zip/Postcode 2509 AE
  Country Netherlands
  Tel +31 (0)70 349 5111
  Fax +31 (0)70 349 5100
  Email info@zonmw.nl
Date applied 16/05/2005
Last edited 21/02/2013
Date ISRCTN assigned 16/05/2005
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.