Improving lifestyle and sleep for inactive adults
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
Run by University Hospital, Grenoble · NCT06424847 · Data updated 2026-11-12
This study is testing a program that combines exercise, better eating, and sleep improvement to see if it helps inactive adults become healthier and lower their risk of heart disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 201 (estimated) |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (Grenoble) |
| Status | Recruiting |
| Started | May 2, 2024 |
| Main results expected | May 1, 2027 |
| Study ends | May 1, 2028 |
| Registry record updated | May 28, 2024 |
| Trial ID | NCT06424847 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are physically inactive adults aged 18 to 80 who can participate in regular physical activity and provide informed consent.
✕Probably not a fit
Patients with diagnosed sleep disturbances or those who are currently participating in another interventional study may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effects of a comprehensive lifestyle intervention that includes physical activity, diet, and sleep improvement strategies in adults who are physically inactive. Participants will be engaged in a program designed to enhance their overall health and reduce the risk of cardiovascular diseases through behavior modification techniques. The study will compare the outcomes of those receiving the lifestyle and sleep intervention against a health education intervention. By addressing both lifestyle and sleep, the study seeks to fill a gap in current prevention strategies for cardiovascular health.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of cardiovascular diseases in inactive adults by promoting healthier lifestyles and better sleep.
How similar studies have gone: Other studies have shown promising results with lifestyle interventions, but the specific combination of lifestyle and sleep interventions in this context is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Grenoble University Hospital
Grenoble, France Recruiting
Study contacts
- Principal investigator: Marie Coudurier, MD — MCoudurier3@chu-grenoble.fr
- Study coordinator: Monique Mendelson, PhD
- Email: mmendelson@chu-grenoble.fr
- Phone: +33 4 76 76 72 26
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.