TOwards Prepared mums (TOP-mums), for a healthy start: A lifestyle intervention to reduce overweight and smoking in women with a pregnancy wish to prevent perinatal morbidity

TOwards Prepared mums (TOP-mums), for a healthy start: A lifestyle intervention to reduce overweight and smoking in women with a pregnancy wish to prevent perinatal morbidity - TOP-mums, for a healthy start

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55392

Enrollment

176

Registered

2015-11-23

Start date

2016-07-27

Completion date

Unknown

Last updated

2024-04-23

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

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a women must meet all of the following criteria: - Women with a pregnancy wish within 1 year - Aged 18-40 years; - (Preconceptional) overweight/obesity (BMI >= 25 kg/m2).

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
- Reduction in body weight: reduction in body weight is measured from baseline, or self-reported body weight in case of inclusion during pregnancy, to 6 weeks postpartum.	—

Secondary

Measure	Time frame
- Gestational weight gain: defined as weight at the beginning of the pregnancy (at the first appointment with the midwife, approximately at 6 weeks gestational age) to the weight at 36 weeks of gestation. - Postpartum weight retention: defined as weight at the beginning of the pregnancy to the weight 6 months postpartum. - Smoking cessation: measured with questionnaires, is 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. - Time to pregnancy. - Vitamin D status: vitamin D insufficiency is defined as a measurement	—

Measure

Time frame

- Gestational weight gain: defined as weight at the beginning of the pregnancy (at the first appointment with the midwife, approximately at 6 weeks gestational age) to the weight at 36 weeks of gestation. - Postpartum weight retention: defined as weight at the beginning of the pregnancy to the weight 6 months postpartum. - Smoking cessation: measured with questionnaires, is 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. - Time to pregnancy. - Vitamin D status: vitamin D insufficiency is defined as a measurement

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)