Effects of a Lifestyle and Sleep Intervention in Non-exercising Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital, Grenoble
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Lifestyle intervention (physical activity and diet)
BehavioralThe 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
BehavioralParticipants 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
BehavioralParticipants randomized to the control group will benefit from a health education intervention in order to limit deception bias.
Treatment groups
201 Participants
are divided into 3 treatment groupsGroup A: Lifestyle intervention (physical activity and diet)Active comparator 1 intervention
Group B: Lifestyle (physical activity and diet) and Sleep interventionActive comparator 1 intervention
Group C: Health education interventionSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Steps per day
Measured using an activity monitor (Actigraph)
Time frame
6 months after randomization2
Health-related quality of life
EuroQol (Europe Quality of Life) EQ-5D-5L questionnaire.The EQ-5D-5L is a brief, multiattribute, generic, health status measure composed of 5 questions with Likert response options (descriptive system). The descriptive system covers 5 dimensions of health (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with 5 levels of severity in each dimension (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems). The worst health state is (55555) and the best health state is (11111).
Time frame
6 months after randomizationSecondary outcomes
1
Subjective sleep quality
Pittsburg Sleep Quality Index. The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.
Time frame
Baseline, 6 months and 12 months2
Sleep duration
Measured using an activity monitor (Actigraph GT3X) and Sunrise sleep
Time frame
Baseline, 6 months and 12 months3
Sleep quality
Measured using an activity monitor (Actigraph GT3X) and Sunrise
Time frame
Baseline, 6 months and 12 months4
Modrate to vigorous intensity physical activity time
Time spent in moderate-to-vigorous physical activity measured by a physical activity monitor, Actigraph GT3X
Time frame
Baseline, 6 months and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov