Actively Recruiting
Effects of a Lifestyle and Sleep Intervention Program on Quality of Life and Physical Activity Levels in Non-exercising Adults, SPIRAL+ Randomized Controlled Trial
Led by University Hospital, Grenoble · Updated on 2024-05-28
201
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cardiovascular diseases are a leading cause of early death and disability worldwide, affecting quality of life and causing economic impacts. This research is studying whether adding a sleep intervention to a lifestyle program can improve health-related quality of life and physical activity levels in adults who do not regularly exercise. The goal is to understand if addressing sleep health alongside physical activity and diet can better reduce cardiovascular risk in people without diagnosed sleep disorders. Participants will be randomly assigned to one of three groups: a lifestyle intervention with physical activity and diet, a combined lifestyle and sleep intervention, or a health education control group. The lifestyle program includes weekly supervised exercise sessions for six months, dietitian consultations, and group or individual diet sessions. The sleep intervention adds personalized sessions based on sleep questionnaires and diaries, with referrals to specialists if needed. The control group receives health education to limit bias. Participants will be assessed at the start, and after 6 and 12 months for quality of life, physical activity levels, cardiovascular and metabolic risk factors, and sleep quality. Researchers will measure daily steps, health-related quality of life, sleep patterns, physical fitness, blood pressure, body composition, mental well-being, and motivation among other factors. The study will run for up to 12 months to track changes and safety over time.
CONDITIONS
Brief Title
Effects of a Lifestyle and Sleep Intervention in Non-exercising Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Physically inactive adults engaging in less than 150 minutes of moderate physical activity per week
- Aged between 18 and 80 years old
- Able to provide written informed consent
- Medically able to participate in regular physical activity without contraindications
- Affiliated to social security or a similar health insurance scheme
You will not qualify if you...
- Any condition that makes participation unsuitable as judged by the study physician or investigator
- Scoring 11111 on the EQ-5D-5L quality of life questionnaire
- Diagnosed and treated sleep disorders such as sleep apnea, insomnia, or restless legs syndrome
- Pregnancy, legal protection measures, or vulnerability as defined by public health codes
- Currently enrolled in another interventional clinical study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants engage in lifestyle interventions which may include physical activity and diet programs, sleep interventions, or health education depending on their assigned group.
Weekly supervised exercise sessions and multiple dietary or sleep follow-up visits depending on intervention group
Duration - 6 months
Participants are monitored for continued outcomes related to physical activity, sleep quality, and quality of life up to 12 months after starting the intervention.
Visits at 6 months and 12 months for assessments
Trial Site Locations
Total: 1 location
1
Grenoble University Hospital
Grenoble, France, 38000
Actively Recruiting
Research Team
M
Monique Mendelson, PhD
M
Marie Coudurier, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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