Study of Antenatal Care Intervention Directed to Pregnant Women With Obesity

NCT ID: NCT03147079

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1354 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-01

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Obesity Complicating Childbirth

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Open intervention study with 2 control arms
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

Lifestyle intervention

Group Type EXPERIMENTAL

Lifestyle intervention

Intervention Type BEHAVIORAL

Internal controls

Group Type EXPERIMENTAL

Lifestyle intervention

Intervention Type BEHAVIORAL

External controls

Group Type EXPERIMENTAL

Lifestyle intervention

Intervention Type BEHAVIORAL

Interventions

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Lifestyle intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* pregnant
* BMI\>30

Exclusion Criteria

* first antenatal care visit after week 20 of the pregnancy
* abortion
* miscarriage
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie Berg, RN PhD

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

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Sahlgrenska Academy, Institute of Health Care Sciences

Gothenburg, , Sweden

Site Status

Countries

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Sweden

References

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Dencker A, Premberg A, Olander EK, McCourt C, Haby K, Dencker S, Glantz A, Berg M. Adopting a healthy lifestyle when pregnant and obese - an interview study three years after childbirth. BMC Pregnancy Childbirth. 2016 Jul 30;16(1):201. doi: 10.1186/s12884-016-0969-x.

Reference Type BACKGROUND
PMID: 27473076 (View on PubMed)

Petrov Fieril K, Fagevik Olsen M, Glantz A, Larsson M. Experiences of exercise during pregnancy among women who perform regular resistance training: a qualitative study. Phys Ther. 2014 Aug;94(8):1135-43. doi: 10.2522/ptj.20120432. Epub 2014 May 1.

Reference Type BACKGROUND
PMID: 24786941 (View on PubMed)

Haby K, Glantz A, Hanas R, Premberg A. Mighty Mums - An antenatal health care intervention can reduce gestational weight gain in women with obesity. Midwifery. 2015 Jul;31(7):685-92. doi: 10.1016/j.midw.2015.03.014. Epub 2015 Apr 9.

Reference Type BACKGROUND
PMID: 25912510 (View on PubMed)

Haby K, Gyllensten H, Hanas R, Berg M, Premberg A. A Lifestyle Intervention During Pregnancy and Its Effects on Child Weight 2.5 Years Later. Matern Child Health J. 2022 Sep;26(9):1881-1890. doi: 10.1007/s10995-022-03395-5. Epub 2022 Mar 6.

Reference Type DERIVED
PMID: 35253077 (View on PubMed)

Gyllensten H, Haby K, Berg M, Premberg A. Cost effectiveness of a controlled lifestyle intervention for pregnant women with obesity. BMC Pregnancy Childbirth. 2021 Sep 21;21(1):639. doi: 10.1186/s12884-021-04098-5.

Reference Type DERIVED
PMID: 34548038 (View on PubMed)

Haby K, Berg M, Gyllensten H, Hanas R, Premberg A. Mighty Mums - a lifestyle intervention at primary care level reduces gestational weight gain in women with obesity. BMC Obes. 2018 Jun 4;5:16. doi: 10.1186/s40608-018-0194-4. eCollection 2018.

Reference Type DERIVED
PMID: 29881627 (View on PubMed)

Other Identifiers

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505-10

Identifier Type: OTHER

Identifier Source: secondary_id

FoU-project id 203431

Identifier Type: -

Identifier Source: org_study_id

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