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| Name | Class |
|---|---|
| Reinier de Graaf Groep | OTHER |
| Janssen-Cilag B.V. | INDUSTRY |
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Rationale: Nutrition and lifestyle interventions are currently not implemented in usual clinical care of PAH-patients. Mainly because there is little known on the relation between pathology, nutrition and lifestyle. Patients who suffer from Pulmonary Arterial Hypertension feel insecure about their nutrition and lifestyle. The investigators hypothesize that an intervention on nutrition and lifestyle can improve the patients' quality of life.
Objective: To explore the effect of a nutrition and lifestyle intervention on quality of life for patients suffering from PAH.
Study design: Investigator initiated intervention study with control group. Study population: investigators aim to include 70 patients (18 - 80 years) with idiopathic, hereditable or drug related PAH, who have been stable for at least three months and are self-sufficient and/or have a family who's willing to participate in the lifestyle changes.
Intervention (if applicable): Nutritional status, - education, - intervention and - compliance.
Main study parameters/endpoints: This is an intervention study in which the investigators will asses the effect of a nutrition and lifestyle intervention on quality of life measured by SF-36 overall outcome with a significant difference of 6.35.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden for the patient exists of 12 extra visits to the hospital and contact moments, over a period of 11 months, as well compliance to the diet and lifestyle. There is minimal risk in participation.
Baseline nutritional assessment
Nutritional education:
8 online lessons containing information about nutrition, lifestyle and general health with complementary tips regarding PH. All participants recieve workbook with assignments.
Nutritional intervention:
Group A: MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids) Group B: MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids) Control group: no diet.
Follow-up:
Patients in intervention arm followed for a period of 6 months to assess compliance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No intervention | |
| E-learning | Experimental | E-learning: 8 lessons about nutrition and lifestyle |
|
| Diet A | Experimental | MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids) |
|
| Diet B | Experimental | MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-learning | Behavioral | 8 lessons about nutrition and lifestyle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life | To asses quality of life, the SF-36 questionnaire is used. | Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in nutritional intake | To asses dietary intake a food frequency questionnaire is used (HELIUS) | Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48) |
| Change in vitamin and mineral status |
| Measure | Description | Time Frame |
|---|---|---|
| Change in exercise capacity | To determine exercise capacity subjects have to perform a six minute walking test | Baseline (week 0), after nutritional intervention (week 24), after follow up (week 48). The Fitbit is worn by intervention group over total study time (48 weeks) |
| Change in heart rate variability |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anton Vonk Noordegraaf, prof. dr. | VUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU medical center | Amsterdam | North Holland | 1008MB | Netherlands |
Data of the study will be kept by the principal investigators and will be available for regulatory authorities. Subjects' personal data will be stored confidentially according to institutional routine. In principle, results will be published in peer-reviewed international journals.
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Randomisation control and E-learning Randomisation Diet A and B
| Diet | Dietary Supplement | Diet A: MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids) Diet B: MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids) |
|
A complete serum analyses is performed to asses vitamin and mineral status. |
| Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48) |
To determine heart rate variability all patients will receive a Fitbit smartwatch. |
| Baseline (week 0), after nutritional intervention (week 24), after follow up (week 48). The Fitbit is worn by intervention group over total study time (48 weeks) |
| Change in daily activity | To determine changes in daily activity the number of steps will be assess by a Fitbit smartwatch | Baseline (week 0), after nutritional intervention (week 24), after follow up (week 48). The Fitbit is worn by intervention group over total study time (48 weeks) |