Ignite Creation Date:
2024-05-06 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05318950
Status:
COMPLETED
Last Update Posted:
2022-04-08
First Post:
2021-12-10
Brief Title:
A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon Effect on quaLity of Life
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UPHILL
Brief Summary:
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 andor have a family whos willing to participate in the lifestyle changes
Intervention if applicable Nutritional status - education - intervention and - compliance
Main study parametersendpoints 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 635
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
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 andor have a family whos willing to participate in the lifestyle changes
Intervention if applicable Nutritional status - education - intervention and - compliance
Main study parametersendpoints 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 635
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None