A lifestyle intervention to reduce gestational weight gain and smoking in pregnant women to prevent perinatal morbidity

A lifestyle intervention to reduce gestational weight gain and smoking in pregnant women to prevent perinatal morbidity - Lifestyle intervention in pregnant women

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48998

Enrollment

106

Registered

2017-11-29

Start date

2018-07-06

Completion date

Unknown

Last updated

2025-03-17

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

Conditions

perinatal complications Unhealthy lifestyle

Interventions

The investigational treatment consists of a lifestyle intervention and will directed towards a healthy diet, adequate physical activity and, if applicable, smoking cessation. The program will start

- Stimulating physical activity of moderate int

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Pregnant women with a gestational age = 25.0 kg/m2). Self-reported prepregnancy weight and measured height at baseline will be used to calculate prepregnancy BMI.

Exclusion criteria

Exclusion criteria: - Haemodynamically significant heart disease; - Restrictive lung disease; - Congenital metabolic disease; - Mentally retarded; - Bariatric surgery; - Diabetes type II, dependent on medicine.

Design outcomes

Primary

Measure	Time frame
Gestational weight gain within the IOM guidelines and the mean weight-for-length z-score of the children at the age of 12 months.	—

Secondary

Measure	Time frame
- Postpartum weight retention: defined as weight at the beginning of the pregnancy to the weight 6 months postpartum. - Smoking cessation: measured with questionnaires, when smoking is present at inclusion. - Biochemical verification of tobacco use, if smoking is present at inclusion: the amount of carbon monoxide (CO) in exhaled breath will be measured using a CO monitor. Biochemical verification will also be done by measurement of urine cotinine. - Dietary habits: for several times, women will be asked to fill in a food diary for seven days. Furthermore, the full-length version of the Three Factor Eating Questionnaire (TFEQ) will be used to assess all of the characteristics of dietary restrain. - Physical activity habits: to measure their daily activity, women will be asked to wear an accelerometer for seven full days for several times. The Baecke questionnaire measures work, sport and leisure activities. - Miscarriage: defined as loss of the fetus before the 20th week of pregnancy. - Vitamin D status: vitamin D insufficiency is defined as a measurement	—

Measure

Time frame

- Postpartum weight retention: defined as weight at the beginning of the pregnancy to the weight 6 months postpartum. - Smoking cessation: measured with questionnaires, when smoking is present at inclusion. - Biochemical verification of tobacco use, if smoking is present at inclusion: the amount of carbon monoxide (CO) in exhaled breath will be measured using a CO monitor. Biochemical verification will also be done by measurement of urine cotinine. - Dietary habits: for several times, women will be asked to fill in a food diary for seven days. Furthermore, the full-length version of the Three Factor Eating Questionnaire (TFEQ) will be used to assess all of the characteristics of dietary restrain. - Physical activity habits: to measure their daily activity, women will be asked to wear an accelerometer for seven full days for several times. The Baecke questionnaire measures work, sport and leisure activities. - Miscarriage: defined as loss of the fetus before the 20th week of pregnancy. - Vitamin D status: vitamin D insufficiency is defined as a measurement

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)