Healthy Living in Pregnancy

Study Overview
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Brief Summary
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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.

Official Title
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Healthy Living in Pregnancy

Conditions
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Lifestyle, Weight Gain, Pregnancy

Intervention / Treatment
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* Behavioral: Lifestyle intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Lifestyle intervention | Behavioral: Lifestyle intervention<br>* 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.<br>|
| No Intervention: No intervention<br>Standard prenatal care, short information leaflet about healthy lifestyle in pregnancy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational weight gain | Proportion of pregnant women showing excessive gestational weight gain according to Institute of Medicine (IOM) guidelines | 4 years |