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An intervention aimed at the prevention of excessive weight gain during pregnancy.

An intervention aimed at the prevention of excessive weight gain during pregnancy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28718
Enrollment
300
Registered
2005-03-11
Start date
2005-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 pr

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: A cohort of 300 women (two times 150), who are approximately seven months pregnant of their first child (nullipara). All healthy women who visit the midwife within 14 weeks after the start of their last menstrual period, and who are pregnant for the first time, will be eligible for inclusion.

Exclusion criteria

Exclusion criteria: Those who are directly referred to a gynaecologist because of complications, and those not able to read/write or communicate in Dutch will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
An assistant will perform the anthropometrical measurements and collect the blood samples at 15, 25, 35 weeks of pregnancy and at 7, 25, 51 weeks after delivery in the midwife practice to measure the following outcome measures: Weight and BMI (change): height is 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

MeasureTime frame
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 skin folds: biceps, triceps, subscapular and suprailiac according to the method described by Weiner and Lourie.11 During pregnancy the suprailliac skin fold measurement won't be executed. Therefore, the thigh skin fold is also measured on all occasions. All skin folds will be assessed twice. A mean value of the two will be computed. In case the two measurements of a skin fold differ more than 10%, the skin fold 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)12. At 15 and 35 weeks of pregnancy and 26 weeks after delivery all participants will wear an (blinded) accelerometer for 3 consecutive days to gather additional data on the levels of physical activity. The focus of dietary intake will be on fat 13,14, fruit and vegetable 15 intake. These questionnaires have been validated. 3. Blood samples: in order to study the influence 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 7, 25, 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 1, insulin growth factor binding protein 1and 3, and cortisol will be measured. Analyses will take place at the laboratory of the VU University Medical Centre. 4. Data (questionnaires) will also

Contacts

Public ContactMireille N.M. Poppel, van

VU University Medical Center, EMGO- Institute, Van der Boechorststraat 7

mnm.vanpoppel@vumc.nl+31 (0)20 4448203

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)