Study of Antenatal Care Intervention Directed to Pregnant Women With Obesity

Not Applicable

Completed

• Conditions: Obesity Complicating Childbirth
• Interventions: Behavioral: Lifestyle intervention

• Registration Number: NCT03147079
• Lead Sponsor: Göteborg University

Brief Summary

The purpose of this study is to determine whether a behavioural intervention focusing on diet and physical activity is cost-effective in decreasing weight gain during pregnancy among pregnant women with body mass index above 30, and has effect on the weight of offspring at birth and at 2.5 years of age

Detailed Description

Obesity in relation to pregnancy is becoming an increasing public health issue and 48% of women assigned to antenatal care in Sweden have overweight (BMI≥25) or obesity (BMI≥30). Obesity is associated with adverse perinatal outcomes, the risks increase with increasing BMI and excessive gestational weight gain (GWG) further increases the risks of adverse pregnancy outcomes. Lifestyle intervention can help pregnant women with obesity to limit their GWG. This study evaluated whether a low-budget antenatal lifestyle intervention programme, with emphasis on nutrition and physical activity, influenced GWG and maternal and perinatal outcomes for pregnant women with obesity. The study also evaluated which specific components of the intervention that had effect.

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2013-12-31
• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-10
• Study Completion: 2017-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1354

Inclusion Criteria

• pregnant
• BMI>30

Exclusion Criteria

• first antenatal care visit after week 20 of the pregnancy
• abortion
• miscarriage

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internal controls	Lifestyle intervention	-
Intervention	Lifestyle intervention	Lifestyle intervention
External controls	Lifestyle intervention	-

Primary Outcome Measures

Name	Time	Method
Gestational weight gain < 7 kg	7 months	Weight gain measured from enrollment/first antenatal care visit to last visit before partum, measured in kg

Trial Locations

Locations (1)

Sahlgrenska Academy, Institute of Health Care Sciences; 🇸🇪 Gothenburg, Sweden