Clinical trial NCT03993145: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Eclampsia
Gestational Diabetes
Keywords: Mentoring
Healthy life style
Postpartum Period
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
name: University of Oslo
name: Helse Nord-Trøndelag HF
name: St. Olavs Hospital
First posted: 2019-06-20
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Recruitment
timeFrame: baseline
measure: Retention
timeFrame: 3 months
measure: Retention
timeFrame: 6 months
measure: Adherence
timeFrame: 3 months
measure: Adherence
timeFrame: 6 months
Secondary outcomes:
measure: Adherence to Norwegian food-based dietary guidelines
timeFrame: 3 months
measure: Adherence to Norwegian food-based dietary guidelines
timeFrame: 6 months
measure: Changes in physical activity levels
timeFrame: baseline, 3 months
measure: Changes in physical activity levels
timeFrame: baseline, 6 months
measure: Changes in body weight
timeFrame: Baseline, 3 months
measure: Changes in body weight
timeFrame: Baseline, 6 months
measure: Changes in blood pressure
timeFrame: Baseline, 3 months
measure: Changes in blood pressure
timeFrame: Baseline, 6 months
measure: Changes in total cholesterol
timeFrame: Baseline, 3 months
measure: Changes in total cholesterol
timeFrame: Baseline, 6 months
measure: Changes in HbA1c
timeFrame: Baseline, 3 months
measure: Changes in HbA1c
timeFrame: Baseline, 6 months
Other outcomes:
measure: Participant satisfaction
timeFrame: 9 months
Locations:
city: Levanger
country: Norway
facility: Levanger sykehus
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology NTNU
name: Siri Forsmo, md prof
role: STUDY_DIRECTOR
References: