Study of Antenatal Care Intervention Directed to Pregnant Women With Obesity

Obesity Complicating Childbirth Clinical Trial

— Mighty Mums  

Official title:

Mighty Mums - a Lifestyle Intervention at Primary Care Level for Pregnant Women With Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03147079
• Other study ID #: FoU-project id 203431
• Secondary ID: 505-10
• Status: Completed
• Phase: N/A
• Start date: January 1, 2011
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2019
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1354
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• pregnant

• BMI>30

Exclusion Criteria:

• first antenatal care visit after week 20 of the pregnancy

• abortion

• miscarriage

Related Conditions & MeSH terms

• Obesity
• Obesity Complicating Childbirth

Intervention

Behavioral:
• Lifestyle intervention

Locations

Country	Name	City	State
Sweden	Sahlgrenska Academy, Institute of Health Care Sciences	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Dencker A, Premberg Å, 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. — View Citation

Haby K, Glantz A, Hanas R, Premberg Å. 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. — View Citation

Petrov Fieril K, Fagevik Olsén 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational weight gain < 7 kg	Weight gain measured from enrollment/first antenatal care visit to last visit before partum, measured in kg	7 months