Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424847
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-04-25
Brief Title:
Effects of a Lifestyle and Sleep Intervention in Non-exercising Adults
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Effects of a Lifestyle and Sleep Intervention Program on Quality of Life and Physical Activity Levels in Non-exercising Adults SPIRAL Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
SPIRAL
Brief Summary:
Background Cardiovascular diseases CVDs are the leading cause of premature mortality and disability accounting for one third of all deaths worldwide with considerable impacts on economics and on quality of life Recent studies suggest that a lifestyle intervention might have a role in the reduction of CDV risk Lifestyle intervention programs typically combine physical activity diet and behavior modification components Poor sleep health is highly prevalent in the general population and contributes to increased risk of several noncommunicable diseases However sleep is rarely addressed in lifestyle intervention programs in primary prevention Given the high prevalence of poor sleep health in people without a diagnosed sleep disorder and the associated health consequences there is a clear need for broad-reaching effective interventions to improve sleep quality in subclinical populations
Aims The main objective of this study is to compare a lifestyle intervention program including a sleep intervention compared to a lifestyle intervention program alone on the health-related quality of life measured by the EQ-5D-5L and physical activity levels of non-exercising adults
Methods Non-exercising adults n201 will be recruited in the community via advertisement or their primary care doctor and then randomized to one of the following 3 groups lifestyle intervention lifestyle and sleep intervention or standard care The lifestyle intervention includes a physical activity component physical activity initiation visit and 6 months of supervised physical activity once weekly a diet component consultation with a dietician and 3 group sessions The sleep intervention includes individualized face-to-face sessions aimed at improving and optimizing sleep hygiene
At baseline and after 6 and 12 months quality of life physical activity levels cardiovascular and metabolic risk factors will be evaluated
Perspectives This study should determine whether adding a sleep intervention dimension to a lifestyle intervention program provides significant benefits in terms of quality of life and physical activity levels Based on this study the modalities of real-life lifestyle intervention programs could be reconsidered in order to provide optimal primary prevention
Aims The main objective of this study is to compare a lifestyle intervention program including a sleep intervention compared to a lifestyle intervention program alone on the health-related quality of life measured by the EQ-5D-5L and physical activity levels of non-exercising adults
Methods Non-exercising adults n201 will be recruited in the community via advertisement or their primary care doctor and then randomized to one of the following 3 groups lifestyle intervention lifestyle and sleep intervention or standard care The lifestyle intervention includes a physical activity component physical activity initiation visit and 6 months of supervised physical activity once weekly a diet component consultation with a dietician and 3 group sessions The sleep intervention includes individualized face-to-face sessions aimed at improving and optimizing sleep hygiene
At baseline and after 6 and 12 months quality of life physical activity levels cardiovascular and metabolic risk factors will be evaluated
Perspectives This study should determine whether adding a sleep intervention dimension to a lifestyle intervention program provides significant benefits in terms of quality of life and physical activity levels Based on this study the modalities of real-life lifestyle intervention programs could be reconsidered in order to provide optimal primary prevention
Detailed Description:
None
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