201
Participants
Start Date
May 2, 2024
Primary Completion Date
May 1, 2027
Study Completion Date
May 1, 2028
Lifestyle intervention (physical activity and diet)
"The physical activity intervention will be based on validated behavior change theories aimed at the initiation and long-term maintenance of physical activity.~Participants will be referred to specialists in Adapted Physical Activity for a 6-month program. Exercise sessions will include aerobic exercise and muscle strengthening exercises. Participants will participate in one supervised sessions per week. They will receive instructions for exercising on their own on the other days in order to reach physical activity guidelines. They will also receive instructions and tips to limit sedentary behavior and increase their physical activity throughout the day.~Participants will benefit from an initial consultation with a dietitian and 4 follow-up visits. The follow-up visits will be either group-based or individual, based on participants choice and availabilities. Dietary recommendations will be based on public health guidelines in France aimed at eating a healthy, balanced diet."
Lifestyle (physical activity and diet) and Sleep intervention
"Participants will benefit from the physical activity and diet intervention detailed above and the following sleep intervention. Participants will fill out an online sleep diagnostic tool includes validated sleep questionnaires (Pittsburgh Sleep Quality Index, Epworth sleepiness scale, Insomnia Severity Index, Berlin questionnaire, Horne and Ostberg questionnaire).~Participants will also log their sleep habits in a 14-day sleep diary. Based on the sleep specialists' review of the results of the questionnaires, sleep diary and analysis of sleep-wake patterns, participants who require further exploration will be referred to a sleep specialist for a consultation and if necessary the appropriate treatment for their sleep disorder.~All participants in this group will benefit from an individualized sleep hygiene intervention. They will benefit from a baseline interview and 3 follow-up visits."
Health education intervention
Participants randomized to the control group will benefit from a health education intervention in order to limit deception bias.
RECRUITING
Grenoble University Hospital, Grenoble
University Hospital, Grenoble
OTHER