Lifestyle Intervention for Women With Recent Pre-eclampsia or Gestational Diabetes Mellitus ('Mom's Healthy Heart')
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Web-based lifestyle intervention 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).
|
Outcome Measures
Primary Outcome Measures
- Recruitment [baseline]
Proportion of eligible patients enrolled in the study
- Retention [3 months]
Proportion of participants kept in the study
- Retention [6 months]
Proportion of participants kept in the study
- Adherence [3 months]
Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician)
- Adherence [6 months]
Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician)
Secondary Outcome Measures
- 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.
- 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 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)
- 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 body weight [Baseline, 3 months]
Changes in body weight measured in kilograms
- Changes in body weight [Baseline, 6 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 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)
- Changes in total cholesterol [Baseline, 3 months]
Changes in total cholesterol measured in mmol/l in non fasting blood samples
- Changes in total cholesterol [Baseline, 6 months]
Changes in total cholesterol measured in mmol/l in non fasting blood samples
- Changes in HbA1c [Baseline, 3 months]
Changes in HbA1c 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
Other Outcome Measures
- Participant satisfaction [9 months]
Participants will complete qualitative surveys and participate in semi-structured interviews to measure their satisfaction with the intervention program.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of preeclampsia or gestational diabetes in recent pregnancy, confirmed by medical record review
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capable to speak and read Norwegian
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access to internet enabled mobile devices that use either iOS or Android operating systems
Exclusion Criteria:
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Diagnosis of chronic hypertension or diabetes mellitus
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current use of blood pressure lowering medication
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medication known to affect glucose tolerance
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active self-reported eating disorder
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history of heart disease, stroke or kidney disease
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history of gastric bypass or bowel surgery resulting in malabsorption
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active medical problems that would interfere with following the diet, or with changes in blood pressure and/or weight
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Levanger sykehus | Levanger | Norway | ||
| 2 | St Olavs Hospital | Trondheim | Norway |
Sponsors and Collaborators
- Norwegian University of Science and Technology
- Harvard Medical School (HMS and HSDM)
- University of Oslo
- Helse Nord-Trøndelag HF
- St. Olavs Hospital
Investigators
- Study Director: Siri Forsmo, md prof, Norwegian University of Science and Technology NTNU
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018/1803