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

Study Overview
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Brief Summary
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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.

Official Title
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Lifestyle Intervention for Women With Recent Pre-eclampsia or Gestational Diabetes Mellitus: A Pilot Intervention Study

Conditions
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Pre-Eclampsia, Gestational Diabetes

Intervention / Treatment
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* Behavioral: Web-based lifestyle intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-based lifestyle intervention<br>participants will be provided access to web-based lifestyle intervention program with personalized coaching from a clinical dietician | Behavioral: Web-based lifestyle intervention<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | Proportion of eligible patients enrolled in the study | baseline | 
| Retention | Proportion of participants kept in the study | 3 months | 
| Retention | Proportion of participants kept in the study | 6 months | 
| Adherence | Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician) | 3 months | 
| Adherence | Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 
| 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. | 6 months | 
| 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) | baseline, 3 months | 
| 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) | baseline, 6 months | 
| Changes in body weight | Changes in body weight measured in kilograms | Baseline, 3 months | 
| Changes in body weight | Changes in body weight measured in kilograms | Baseline, 6 months | 
| 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) | Baseline, 3 months | 
| 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) | Baseline, 6 months | 
| Changes in total cholesterol | Changes in total cholesterol measured in mmol/l in non fasting blood samples | Baseline, 3 months | 
| Changes in total cholesterol | Changes in total cholesterol measured in mmol/l in non fasting blood samples | Baseline, 6 months | 
| Changes in HbA1c | Changes in HbA1c measured in mmol/l in non fasting blood samples | Baseline, 3 months | 
| Changes in HbA1c | Changes in HbA1c measured in mmol/l in non fasting blood samples | Baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mentoring, Healthy life style, Postpartum Period