Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-01-04 @ 1:20 PM
Study NCT ID:
NCT05318950
Status:
COMPLETED
Last Update Posted:
2022-04-08
First Post:
2021-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon
Sponsor:
Amsterdam UMC, location VUmc
Organization:
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 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.
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.
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:
True
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?: