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

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ClinicalTrials.gov Identifier: NCT03147079
Recruitment Status : Completed
First Posted : May 10, 2017
Last Update Posted : May 2, 2019
Sponsor:
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Obesity Complicating Childbirth Behavioral: Lifestyle intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1354 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open intervention study with 2 control arms
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mighty Mums - a Lifestyle Intervention at Primary Care Level for Pregnant Women With Obesity
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : December 31, 2013
Actual Study Completion Date : December 31, 2017

Arm Intervention/treatment
Experimental: Intervention
Lifestyle intervention
Behavioral: Lifestyle intervention
Experimental: Internal controls Behavioral: Lifestyle intervention
Experimental: External controls Behavioral: Lifestyle intervention



Primary Outcome Measures :
  1. Gestational weight gain < 7 kg [ Time Frame: 7 months ]
    Weight gain measured from enrollment/first antenatal care visit to last visit before partum, measured in kg



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnant
  • BMI>30

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147079


Locations
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Sweden
Sahlgrenska Academy, Institute of Health Care Sciences
Gothenburg, Sweden
Sponsors and Collaborators
Göteborg University
Vastra Gotaland Region
Investigators
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Principal Investigator: Marie Berg, RN PhD Göteborg University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03147079     History of Changes
Other Study ID Numbers: FoU-project id 203431
505-10 ( Other Identifier: Approval number from the ethical review board )
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Göteborg University:
obesity
pregnancy
lifestyle
gestational weight gain
weight of offspring
antenatal care
health behavior
physical activity
diet
programme evaluation
costs and costs analysis

Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms