NCT03147079

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,354

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

3 years

First QC Date

May 8, 2017

Last Update Submit

April 3, 2025

Conditions

Obesity Complicating Childbirth

Keywords

obesitypregnancylifestylegestational weight gainweight of offspringantenatal carehealth behaviorphysical activitydietprogramme evaluationcosts and costs analysis

Outcome Measures

Primary Outcomes (1)

  • Gestational weight gain < 7 kg

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

    7 months

Study Arms (3)

Intervention

EXPERIMENTAL

Lifestyle intervention

Behavioral: Lifestyle intervention

Internal controls

EXPERIMENTAL
Behavioral: Lifestyle intervention

External controls

EXPERIMENTAL
Behavioral: Lifestyle intervention

Interventions

Lifestyle interventionBEHAVIORAL
External controlsInternal controlsIntervention

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • pregnant
  • BMI\>30

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska Academy, Institute of Health Care Sciences

Gothenburg, Sweden

Location

Related Publications (6)

  • 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.

    PMID: 27473076BACKGROUND

  • 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.

    PMID: 24786941BACKGROUND

  • 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.

    PMID: 25912510BACKGROUND

  • 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.

    PMID: 35253077DERIVED

  • 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.

    PMID: 34548038DERIVED

  • 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.

    PMID: 29881627DERIVED

MeSH Terms

Conditions

ObesityGestational Weight GainHealth BehaviorMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsWeight GainBody Weight ChangesBehavior

Study Officials

  • Marie Berg, RN PhD

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Open intervention study with 2 control arms
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2017

First Posted

May 10, 2017

Study Start

January 1, 2011

Primary Completion

December 31, 2013

Study Completion

December 31, 2017

Last Updated

April 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)