Condition category
Pregnancy and Childbirth
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Mireille NM van Poppel


Contact details

Afdeling Sociale Geneeskunde/EMGO Instituut
Van der Boechorststraat 7
1081 BT
+31 (0)20 444 82 03

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


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


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Weight-gain during pregnancy


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



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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment


Trial participating centre

Afdeling Sociale Geneeskunde/EMGO Instituut
1081 BT

Sponsor information


Netherlands Organisation for Health Research and Development (ZonMw)

Sponsor details

Laan van Nieuw Oost Indië 334
PO Box 93 245
The Hague
2509 AE
+31 (0)70 349 5111

Sponsor type

Research organisation



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


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
2. 2013 results in

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes