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

Not Applicable

Completed

• Conditions: Gestational Diabetes; Pre-Eclampsia

• Registration Number: NCT03993145
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-20
• Study Start: 2020-02-07
• Status Verified: 2021-05
• Primary Completion: 2021-05-04
• Study Completion: 2021-05-04
• Last Update Submitted: 2021-05-11
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adherence	6 months	Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician)
Recruitment	baseline	Proportion of eligible patients enrolled in the study
Retention	6 months	Proportion of participants kept in the study

Secondary Outcome Measures

Name	Time	Method
Changes in physical activity levels	baseline, 6 months	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 total cholesterol	Baseline, 6 months	Changes in total cholesterol measured in mmol/l in non fasting blood samples
Changes in HbA1c	Baseline, 6 months	Changes in HbA1c measured in mmol/l in non fasting blood samples
Changes in body weight	Baseline, 6 months	Changes in body weight measured in kilograms
Adherence to Norwegian food-based dietary guidelines	6 months	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 blood pressure	Baseline, 6 months	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)

Trial Locations

Locations (2)

Levanger sykehus; 🇳🇴 Levanger, Norway

St Olavs Hospital; 🇳🇴 Trondheim, Norway