Healthy Living in Pregnancy

N/ACompletedNCT01958307

Technical University of Munich2,286 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

2,286

Conditions

Lifestyle Weight Gain Pregnancy

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 43 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Gestational age ≤ 12th week of gestation * Age: 18 years to 43 years * Prepregnancy BMI ≥ 18.5 kg/m2 and ≤ 40.0 kg/m2 * Sufficient German language skills * Written informed consent Exclusion Criteria: * Multiple pregnancy * Any condition preventing physical activity such as placenta praevia, persistent bleeding, cervical incompetence * Prepregnancy diabetes or early diagnosed gestational diabetes * Uncontrolled chronic diseases (e.g. thyroid dysfunction) * Psychiatric or psychosomatic diseases * Any condition that may interfere with the study protocol