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Lifestyle Intervention for Women With Recent Pre-eclampsia or Gestational Diabetes Mellitus ('Mom's Healthy Heart')

Primary Purpose

Pre-Eclampsia, Gestational Diabetes

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Web-based lifestyle intervention
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-Eclampsia focused on measuring Mentoring, Healthy life style, Postpartum Period

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of preeclampsia or gestational diabetes in recent pregnancy, confirmed by medical record review
  • capable to speak and read Norwegian
  • access to internet enabled mobile devices that use either iOS or Android operating systems

Exclusion Criteria:

  • Diagnosis of chronic hypertension or diabetes mellitus
  • current use of blood pressure lowering medication
  • medication known to affect glucose tolerance
  • active self-reported eating disorder
  • history of heart disease, stroke or kidney disease
  • history of gastric bypass or bowel surgery resulting in malabsorption
  • active medical problems that would interfere with following the diet, or with changes in blood pressure and/or weight

Sites / Locations

  • Levanger sykehus
  • St Olavs Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Web-based lifestyle intervention

Arm Description

participants will be provided access to web-based lifestyle intervention program with personalized coaching from a clinical dietician

Outcomes

Primary Outcome Measures

Recruitment
Proportion of eligible patients enrolled in the study
Retention
Proportion of participants kept in the study
Retention
Proportion of participants kept in the study
Adherence
Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician)
Adherence
Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician)

Secondary Outcome Measures

Adherence to Norwegian food-based dietary guidelines
We will use the NORDIET food frequency questionnaire to measure adherence to the qualitative recommendations of the Norwegian food-based dietary guidelines (FBDG) (Henriksen et al. 2018). We will measure the proportion of participants complying with the Norwegian FBDG.
Adherence to Norwegian food-based dietary guidelines
We will use the NORDIET food frequency questionnaire to measure adherence to the qualitative recommendations of the Norwegian food-based dietary guidelines (Henriksen et al. 2018). We will measure the proportion of participants complying with the Norwegian FBDG.
Changes in physical activity levels
Changes in physical activity levels assessed by physical activity sensors (two tri-axial accelerometers, AX3 Axivity, one on the thigh and second on lower back)
Changes in physical activity levels
Changes in physical activity levels assessed by physical activity sensors (two tri-axial accelerometers, AX3 Axivity, one on the thigh and second on lower back)
Changes in body weight
Changes in body weight measured in kilograms
Changes in body weight
Changes in body weight measured in kilograms
Changes in blood pressure
Changes in blood pressure in mmHg (measured three times at 1-minute intervals after the participant has come to rest, using an automatic oscillometric method with cuff size adjusted to arm circumference)
Changes in blood pressure
Changes in blood pressure in mmHg (measured three times at 1-minute intervals after the participant has come to rest, using an automatic oscillometric method with cuff size adjusted to arm circumference)
Changes in total cholesterol
Changes in total cholesterol measured in mmol/l in non fasting blood samples
Changes in total cholesterol
Changes in total cholesterol measured in mmol/l in non fasting blood samples
Changes in HbA1c
Changes in HbA1c measured in mmol/l in non fasting blood samples
Changes in HbA1c
Changes in HbA1c measured in mmol/l in non fasting blood samples

Full Information

First Posted
June 18, 2019
Last Updated
May 11, 2021
Sponsor
Norwegian University of Science and Technology
Collaborators
Harvard Medical School (HMS and HSDM), University of Oslo, Helse Nord-Trøndelag HF, St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03993145
Brief Title
Lifestyle Intervention for Women With Recent Pre-eclampsia or Gestational Diabetes Mellitus ('Mom's Healthy Heart')
Official Title
Lifestyle Intervention for Women With Recent Pre-eclampsia or Gestational Diabetes Mellitus: A Pilot Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 7, 2020 (Actual)
Primary Completion Date
May 4, 2021 (Actual)
Study Completion Date
May 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Harvard Medical School (HMS and HSDM), University of Oslo, Helse Nord-Trøndelag HF, St. Olavs Hospital

4. Oversight

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

5. Study Description

Brief Summary
The aim of this pilot intervention study is to develop and test a tailored web-based lifestyle modification program for women with recent preeclampsia or gestational diabetes. Women will start the study 3-15 months postpartum. After obtaining written informed consent and confirmation of eligibility criteria, eligible women will be included in the pilot study using a single arm study design (all women will be assigned to the lifestyle intervention program). Participants will be provided access to a web-based lifestyle intervention program with personalized coaching from a registered dietician.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia, Gestational Diabetes
Keywords
Mentoring, Healthy life style, Postpartum Period

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Web-based lifestyle intervention
Arm Type
Experimental
Arm Description
participants will be provided access to web-based lifestyle intervention program with personalized coaching from a clinical dietician
Intervention Type
Behavioral
Intervention Name(s)
Web-based lifestyle intervention
Intervention Description
Lifestyle intervention program including educational modules on diet and physical activity with visual and audio. Phone conversation with the clinical dietician at week 1, week 3, week 6, week 12 and month 6 (completion of the study).
Primary Outcome Measure Information:
Title
Recruitment
Description
Proportion of eligible patients enrolled in the study
Time Frame
baseline
Title
Retention
Description
Proportion of participants kept in the study
Time Frame
3 months
Title
Retention
Description
Proportion of participants kept in the study
Time Frame
6 months
Title
Adherence
Description
Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician)
Time Frame
3 months
Title
Adherence
Description
Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Adherence to Norwegian food-based dietary guidelines
Description
We will use the NORDIET food frequency questionnaire to measure adherence to the qualitative recommendations of the Norwegian food-based dietary guidelines (FBDG) (Henriksen et al. 2018). We will measure the proportion of participants complying with the Norwegian FBDG.
Time Frame
3 months
Title
Adherence to Norwegian food-based dietary guidelines
Description
We will use the NORDIET food frequency questionnaire to measure adherence to the qualitative recommendations of the Norwegian food-based dietary guidelines (Henriksen et al. 2018). We will measure the proportion of participants complying with the Norwegian FBDG.
Time Frame
6 months
Title
Changes in physical activity levels
Description
Changes in physical activity levels assessed by physical activity sensors (two tri-axial accelerometers, AX3 Axivity, one on the thigh and second on lower back)
Time Frame
baseline, 3 months
Title
Changes in physical activity levels
Description
Changes in physical activity levels assessed by physical activity sensors (two tri-axial accelerometers, AX3 Axivity, one on the thigh and second on lower back)
Time Frame
baseline, 6 months
Title
Changes in body weight
Description
Changes in body weight measured in kilograms
Time Frame
Baseline, 3 months
Title
Changes in body weight
Description
Changes in body weight measured in kilograms
Time Frame
Baseline, 6 months
Title
Changes in blood pressure
Description
Changes in blood pressure in mmHg (measured three times at 1-minute intervals after the participant has come to rest, using an automatic oscillometric method with cuff size adjusted to arm circumference)
Time Frame
Baseline, 3 months
Title
Changes in blood pressure
Description
Changes in blood pressure in mmHg (measured three times at 1-minute intervals after the participant has come to rest, using an automatic oscillometric method with cuff size adjusted to arm circumference)
Time Frame
Baseline, 6 months
Title
Changes in total cholesterol
Description
Changes in total cholesterol measured in mmol/l in non fasting blood samples
Time Frame
Baseline, 3 months
Title
Changes in total cholesterol
Description
Changes in total cholesterol measured in mmol/l in non fasting blood samples
Time Frame
Baseline, 6 months
Title
Changes in HbA1c
Description
Changes in HbA1c measured in mmol/l in non fasting blood samples
Time Frame
Baseline, 3 months
Title
Changes in HbA1c
Description
Changes in HbA1c measured in mmol/l in non fasting blood samples
Time Frame
Baseline, 6 months
Other Pre-specified Outcome Measures:
Title
Participant satisfaction
Description
Participants will complete qualitative surveys and participate in semi-structured interviews to measure their satisfaction with the intervention program.
Time Frame
9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of preeclampsia or gestational diabetes in recent pregnancy, confirmed by medical record review capable to speak and read Norwegian access to internet enabled mobile devices that use either iOS or Android operating systems Exclusion Criteria: Diagnosis of chronic hypertension or diabetes mellitus current use of blood pressure lowering medication medication known to affect glucose tolerance active self-reported eating disorder history of heart disease, stroke or kidney disease history of gastric bypass or bowel surgery resulting in malabsorption active medical problems that would interfere with following the diet, or with changes in blood pressure and/or weight
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siri Forsmo, md prof
Organizational Affiliation
Norwegian University of Science and Technology NTNU
Official's Role
Study Director
Facility Information:
Facility Name
Levanger sykehus
City
Levanger
Country
Norway
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Lifestyle Intervention for Women With Recent Pre-eclampsia or Gestational Diabetes Mellitus ('Mom's Healthy Heart')

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