An intervention aimed at the prevention of excessive weight gain during pregnancy
| ISRCTN | ISRCTN85313483 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85313483 |
| Protocol serial number | NTR32 |
| Sponsor | Netherlands Organisation for Health Research and Development (ZonMw) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: project 4010.0017) |
- Submission date
- 16/05/2005
- Registration date
- 16/05/2005
- Last edited
- 21/02/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Afdeling Sociale Geneeskunde/EMGO Instituut
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 444 82 03 |
|---|---|
| mnm.vanpoppel@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | New Life(style) |
| Study objectives | 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(s) | The Medical Ethics Committee of VU University Medical Centre has approved the study design, protocols and informed consent procedure. |
| Health condition(s) or problem(s) studied | 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 |
| 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: |
| Key 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. |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 300 |
| Key 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 |
| Key exclusion criteria | 1. Those who are directly referred to a gynaecologist because of complications 2. Unable to read/write or communicate in Dutch |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
1081 BT
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2013 | Yes | No | |
| Protocol article | protocol | 26/06/2006 | Yes | No |