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Study of Antenatal Care Intervention Directed to Pregnant Women With Obesity (Mighty Mums)

G

Göteborg University

Status

Completed

Conditions

Obesity Complicating Childbirth

Treatments

Behavioral: Lifestyle intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03147079
FoU-project id 203431
505-10 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

1,354 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • pregnant
  • BMI>30

Exclusion criteria

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,354 participants in 3 patient groups

Intervention
Experimental group
Description:
Lifestyle intervention
Treatment:
Behavioral: Lifestyle intervention
Internal controls
Experimental group
Treatment:
Behavioral: Lifestyle intervention
External controls
Experimental group
Treatment:
Behavioral: Lifestyle intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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