Gestational Diabetes, Pre-Eclampsia
Conditions
Keywords
Mentoring, Healthy life style, Postpartum Period
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.
Interventions
BEHAVIORALWeb-based lifestyle intervention
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).
Sponsors
Harvard Medical School (HMS and HSDM)
University of Oslo
Helse Nord-Trøndelag HF
St. Olavs Hospital
Norwegian University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 3 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 | 3 months | Proportion of participants kept in the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in body weight | Baseline, 3 months | Changes in body weight measured in kilograms |
| Changes in blood pressure | Baseline, 3 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) |
| Changes in HbA1c | Baseline, 3 months | Changes in HbA1c measured in mmol/l in non fasting blood samples |
| Changes in total cholesterol | Baseline, 3 months | Changes in total cholesterol measured in mmol/l in non fasting blood samples |
| Adherence to Norwegian food-based dietary guidelines | 3 months | 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. |
| Changes in physical activity levels | baseline, 3 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Participant satisfaction | 9 months | Participants will complete qualitative surveys and participate in semi-structured interviews to measure their satisfaction with the intervention program. |
Countries
Norway
Outcome results
None listed