Lifestyle Intervention for Women With Recent Pre-eclampsia or Gestational Diabetes Mellitus: A Pilot Intervention Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pre-Eclampsia
- Sponsor
- Norwegian University of Science and Technology
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Adherence
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Adherence
Time Frame: 6 months
Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician)
Recruitment
Time Frame: baseline
Proportion of eligible patients enrolled in the study
Retention
Time Frame: 6 months
Proportion of participants kept in the study
Secondary Outcomes
- Changes in physical activity levels(baseline, 6 months)
- Changes in total cholesterol(Baseline, 6 months)
- Changes in HbA1c(Baseline, 6 months)
- Changes in body weight(Baseline, 6 months)
- Adherence to Norwegian food-based dietary guidelines(6 months)
- Changes in blood pressure(Baseline, 6 months)