Effects of a Lifestyle and Sleep Intervention in Non-exercising Adults (SPIRAL+)
Status
Conditions
Treatments
Details and patient eligibility
About
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 (n=201) 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Participant who is physically inactive (i.e. less than 150 minutes of moderate intensity physical activity per week)
- Participant aged 18 to 80 years old
- Participant able to provide written informed consent
- Participant able to participate in regular physical activity (no medical contraindication to exercise)
- Participant affiliated to social security or a similar regimen
Exclusion criteria
- Any condition that in the opinion of the responsible physician or investigator makes the potential participant unsuitable for the study
- A participant who scores 11111 on the EQ-5D-5L questionnaire
- A diagnosed and treated sleep disturbance (sleep apnea, insomnia, restless legs syndrome)
- Persons concerned by articles L1121-5, L1121-6 and L1121-8 of the public health code (i.e. pregnancy, person deprived of liberty or subject to a legal protection measure, vulnerable person or legally protected adult)
- Person already included in another interventional study
Trial design
Primary purpose
Allocation
Interventional model
Masking
201 participants in 3 patient groups
Trial contacts and locations
Loading...
Central trial contact
Monique Mendelson, PhD; Marie Coudurier, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal