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

Primary Purpose

Obesity Complicating Childbirth

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Lifestyle intervention
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity Complicating Childbirth focused on measuring obesity, pregnancy, lifestyle, gestational weight gain, weight of offspring, antenatal care, health behavior, physical activity, diet, programme evaluation, costs and costs analysis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • pregnant
  • BMI>30

Exclusion Criteria:

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

Sites / Locations

  • Sahlgrenska Academy, Institute of Health Care Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Intervention

Internal controls

External controls

Arm Description

Lifestyle intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 8, 2017
Last Updated
April 30, 2019
Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT03147079
Brief Title
Study of Antenatal Care Intervention Directed to Pregnant Women With Obesity
Acronym
Mighty Mums
Official Title
Mighty Mums - a Lifestyle Intervention at Primary Care Level for Pregnant Women With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2011 (Actual)
Primary Completion Date
December 31, 2013 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity Complicating Childbirth
Keywords
obesity, pregnancy, lifestyle, gestational weight gain, weight of offspring, antenatal care, health behavior, physical activity, diet, programme evaluation, costs and costs analysis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open intervention study with 2 control arms
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1354 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Lifestyle intervention
Arm Title
Internal controls
Arm Type
Experimental
Arm Title
External controls
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Primary Outcome Measure Information:
Title
Gestational weight gain < 7 kg
Description
Weight gain measured from enrollment/first antenatal care visit to last visit before partum, measured in kg
Time Frame
7 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: pregnant BMI>30 Exclusion Criteria: first antenatal care visit after week 20 of the pregnancy abortion miscarriage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Berg, RN PhD
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska Academy, Institute of Health Care Sciences
City
Gothenburg
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27473076
Citation
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.
Results Reference
background
PubMed Identifier
24786941
Citation
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.
Results Reference
background
PubMed Identifier
25912510
Citation
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.
Results Reference
background
PubMed Identifier
35253077
Citation
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.
Results Reference
derived
PubMed Identifier
34548038
Citation
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.
Results Reference
derived
PubMed Identifier
29881627
Citation
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.
Results Reference
derived

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Study of Antenatal Care Intervention Directed to Pregnant Women With Obesity

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