NCT01958307

Healthy Living in Pregnancy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,286 (actual)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: Female
• Age: 18 Years – 43 Years
• Healthy volunteers: Accepted

Summary

Multicenter and multidisciplinary public health project in 10 regions of Bavaria, a federal state of Germany, targeting maternal and fetal health. The objective of this trial is to evaluate the efficacy of a lifestyle intervention program focusing on diet, physical activity and weight monitoring during pregnancy. The intervention comprises 4 individual counseling sessions addressing healthy living. Primary outcome: gestational weight gain. Secondary outcomes are pregnancy and obstetric complications like gestational diabetes and rate of caesarean sections as well as offspring health. The lifestyle intervention program is adapted to the German health care system to allow an immediate implementation after successful evaluation.

Conditions

• Lifestyle
• Weight Gain
• Pregnancy

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle intervention	The intervention program consists of four individual counseling modules focusing on diet, physical activity and weight monitoring (12th-16th, 16th-20th, 30th-34th week of gestation and 6th-8th week postpartum). The counseling sessions are given by carefully trained midwives or medical staff in combination with prenatal visits and follow a standardized curriculum. Women are provided with brochures including a list of adequate prenatal exercise programs and a pedometer. Furthermore, they receive a chart personalized according to their baseline BMI category to monitor weight development.

Timeline

• Start date: 2013-09-01
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2013-10-09
• Last updated: 2023-12-15

Locations

5 sites across 1 country: Germany