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Obesity Complicating ChildbirthMighty MumsNCT03147079

Study of Antenatal Care Intervention Directed to Pregnant Women With Obesity

A study testing Lifestyle intervention in people with Obesity Complicating Childbirth, run by Göteborg University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity Complicating Childbirth
What is being tested?
Lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,354 participants
Where
1 siteSweden
Study dates
1 Jan 2011to 31 Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • pregnant
  • BMI>30

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Sahlgrenska Academy, Institute of Health Care Sciences

    Gothenburg

Other trials in Sweden

About this study

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

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

Read the 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.

Being tested
Lifestyle intervention
Keywords
obesity, pregnancy, lifestyle, gestational weight gain, weight of offspring, antenatal care, health behavior, physical activity, diet, programme evaluation, costs and costs analysis
Medical subject headings
Obesity, Gestational Weight Gain, Health Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle interventionBehavioural

Study groups in NCT03147079
Study groupRoleWhat they receive
InterventionExperimentalLifestyle intervention
Receives: Behavioral: Lifestyle intervention
Internal controlsExperimentalNot described
Receives: Behavioral: Lifestyle intervention
External controlsExperimentalNot described
Receives: Behavioral: Lifestyle intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gestational weight gain < 7 kg

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

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2017
  2. Study start1 Jan 2011
  3. Primary completion31 Dec 2013
  4. Study completion31 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Open intervention study with 2 control arms
Masking
None (open label)
Enrolment
1,354 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03147079
Sponsor's protocol ID
FoU-project id 203431
Other IDs
505-10
Acronym
Mighty Mums
Status last verified
Apr 2025
First submitted
8 May 2017
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27473076

  • 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.

    PubMed 24786941

  • 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.

    PubMed 25912510

  • 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.

    PubMed 35253077

  • 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.

    PubMed 34548038

  • 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.

    PubMed 29881627

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle intervention in people with Obesity Complicating Childbirth, run by Göteborg University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gestational weight gain < 7 kg (time frame: 7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03147079, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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