An interventional study of Web-based lifestyle intervention in Pre-Eclampsia and Gestational Diabetes, sponsored by Norwegian University of Science and Technology. Completed at 2 sites in Norway. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-12.
Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Prevention
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.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's enrollment of 44 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
participants will be provided access to web-based lifestyle intervention program with personalized coaching from a clinical dietician
Behavioral: Web-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).
Recruitment
Proportion of eligible patients enrolled in the study
Time frame: baseline
Retention
Proportion of participants kept in the study
Time frame: 3 months
Retention
Proportion of participants kept in the study
Time frame: 6 months
Adherence
Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician)
Time frame: 3 months
Adherence
Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician)
Time frame: 6 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 (FBDG) (Henriksen et al. 2018). We will measure the proportion of participants complying with the Norwegian FBDG.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: baseline, 6 months
Changes in body weight
Changes in body weight measured in kilograms
Time frame: Baseline, 3 months
Changes in body weight
Changes in body weight measured in kilograms
Time frame: 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)
Time frame: 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)
Time frame: Baseline, 6 months
Changes in total cholesterol
Changes in total cholesterol measured in mmol/l in non fasting blood samples
Time frame: Baseline, 3 months
Changes in total cholesterol
Changes in total cholesterol measured in mmol/l in non fasting blood samples
Time frame: Baseline, 6 months
Changes in HbA1c
Changes in HbA1c measured in mmol/l in non fasting blood samples
Time frame: Baseline, 3 months
Changes in HbA1c
Changes in HbA1c measured in mmol/l in non fasting blood samples
Time frame: Baseline, 6 months
Participant satisfaction
Participants will complete qualitative surveys and participate in semi-structured interviews to measure their satisfaction with the intervention program.
Time frame: 9 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Norwegian University of Science and Technology