Contact information
Type
Scientific
Primary contact
Dr Mireille NM van Poppel
ORCID ID
Contact details
Afdeling Sociale Geneeskunde/EMGO Instituut
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 82 03
mnm.vanpoppel@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR32
Study information
Scientific title
Acronym
New Life(style)
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Weight-gain during pregnancy
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 measures
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.
Overall trial start date
01/01/2005
Overall trial end date
31/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
300 (150 in each group)
Participant exclusion criteria
1. Those who are directly referred to a gynaecologist because of complications
2. Unable to read/write or communicate in Dutch
Recruitment start date
01/01/2005
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Afdeling Sociale Geneeskunde/EMGO Instituut
Amsterdam
1081 BT
Netherlands
Sponsor information
Organisation
Netherlands Organisation for Health Research and Development (ZonMw)
Sponsor details
Laan van Nieuw Oost Indië 334
PO Box 93 245
The Hague
2509 AE
Netherlands
+31 (0)70 349 5111
info@zonmw.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: project 4010.0017)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16800869
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23121074
Publication citations
-
Protocol
Althuizen E, van Poppel MN, Seidell JC, van der Wijden C, van Mechelen W, Design of the New Life(style) study: a randomised controlled trial to optimise maternal weight development during pregnancy. [ISRCTN85313483]., BMC Public Health, 2006, 6, 168, doi: 10.1186/1471-2458-6-168.
-
Results
Althuizen E, van der Wijden CL, van Mechelen W, Seidell JC, van Poppel MN, The effect of a counselling intervention on weight changes during and after pregnancy: a randomised trial., BJOG, 2013, 120, 1, 92-99, doi: 10.1111/1471-0528.12014.