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| Name | Class |
|---|---|
| Harvard Medical School (HMS and HSDM) | OTHER |
| University of Oslo | OTHER |
| Helse Nord-Trøndelag HF | OTHER |
| St. Olavs Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Web-based lifestyle intervention | Experimental | participants will be provided access to web-based lifestyle intervention program with personalized coaching from a clinical dietician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-based lifestyle intervention | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | Proportion of eligible patients enrolled in the study | baseline |
| Retention | Proportion of participants kept in the study | 3 months |
| Retention | Proportion of participants kept in the study | 6 months |
| Adherence | Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician) | 3 months |
| Adherence | Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Participant satisfaction | Participants will complete qualitative surveys and participate in semi-structured interviews to measure their satisfaction with the intervention program. | 9 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siri Forsmo, md prof | Norwegian University of Science and Technology NTNU | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Levanger sykehus | Levanger | Norway | ||||
| St Olavs Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37485436 | Derived | Horn J, Kolberg M, Rangul V, Magnussen EB, Asvold BO, Henriksen HB, Blomhoff R, Seely EW, Rich-Edwards J. Feasibility of a Postpartum Web- and Phone-Based Lifestyle Program for Women with a History of Preeclampsia or Gestational Diabetes: A Pilot Intervention Study. Womens Health Rep (New Rochelle). 2023 Jul 18;4(1):345-357. doi: 10.1089/whr.2023.0039. eCollection 2023. |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| OTHER |
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|
| 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. |
| 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) | 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) | baseline, 6 months |
| Changes in body weight | Changes in body weight measured in kilograms | Baseline, 3 months |
| Changes in body weight | Changes in body weight measured in kilograms | 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) | 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) | Baseline, 6 months |
| Changes in total cholesterol | Changes in total cholesterol measured in mmol/l in non fasting blood samples | Baseline, 3 months |
| Changes in total cholesterol | Changes in total cholesterol measured in mmol/l in non fasting blood samples | Baseline, 6 months |
| Changes in HbA1c | Changes in HbA1c measured in mmol/l in non fasting blood samples | Baseline, 3 months |
| Changes in HbA1c | Changes in HbA1c measured in mmol/l in non fasting blood samples | Baseline, 6 months |
| Trondheim |
| Norway |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |