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
About this trial
This is an interventional prevention trial for Pre-Eclampsia focused on measuring Mentoring, Healthy life style, Postpartum Period
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
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
NCT ID
NCT03993145
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
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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