## Protocol Section
### Identification Module
**NCT ID:** NCT03147079

**Acronym:** Mighty Mums

**Brief Title:** Study of Antenatal Care Intervention Directed to Pregnant Women With Obesity

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

#### Organization Study ID Info
**ID:** FoU-project id 203431
#### Organization
**Class:** OTHER
**Full Name:** Göteborg University
#### Secondary ID Infos
**Domain:** Approval number from the ethical review board
**ID:** 505-10
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2017-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-05-02

**Type:** ACTUAL

**Last Update Submit Date:** 2019-04-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2011-01-01

**Type:** ACTUAL

**Status Verified Date:** 2019-04

#### Study First Post Date
**Date:** 2017-05-10
**Type:** ACTUAL
**Study First Submit Date:** 2017-05-08
**Study First Submit QC Date:** 2017-05-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Vastra Gotaland Region

#### Lead Sponsor

**Class:** OTHER

**Name:** Göteborg University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- 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

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Open intervention study with 2 control arms

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 1354

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Lifestyle intervention

**Intervention Names:**

- Behavioral: Lifestyle intervention

**Label:** Intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Behavioral: Lifestyle intervention

**Label:** Internal controls

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Behavioral: Lifestyle intervention

**Label:** External controls

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- External controls

- Internal controls

- Intervention

**Name:** Lifestyle intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Gestational weight gain < 7 kg

**Time Frame:** 7 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* pregnant
* BMI\>30

Exclusion Criteria:

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

**Healthy Volunteers:** True

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Gothenburg

**Country:** Sweden

**Facility:** Sahlgrenska Academy, Institute of Health Care Sciences

#### Overall Officials

**Official 1:**

**Affiliation:** Göteborg University

**Name:** Marie Berg, RN PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 27473076

**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.

**PMID:** 24786941

**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.

**PMID:** 25912510

**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.

**PMID:** 35253077

**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.

**PMID:** 34548038

**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.

**PMID:** 29881627

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M12701

- Name: Obesity

- Relevance: HIGH

- As Found: Obesity

- ID: M18101

- Name: Weight Gain

- Relevance: LOW

- As Found: Unknown

- ID: M1934

- Name: Gestational Weight Gain

- Relevance: LOW

- As Found: Unknown

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009765

- Term: Obesity

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T114

- Name: Chrysanthemum

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
