Effects of a Lifestyle and Sleep Intervention in Non-exercising Adults
SPIRAL+
1 other identifier
interventional
201
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2024
CompletedStudy Start
First participant enrolled
May 2, 2024
CompletedFirst Posted
Study publicly available on registry
May 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
May 28, 2024
May 1, 2024
3 years
April 25, 2024
May 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Steps per day
Measured using an activity monitor (Actigraph)
6 months after randomization
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).
6 months after randomization
Secondary Outcomes (25)
Subjective sleep quality
Baseline, 6 months and 12 months
Sleep duration
Baseline, 6 months and 12 months
Sleep quality
Baseline, 6 months and 12 months
Modrate to vigorous intensity physical activity time
Baseline, 6 months and 12 months
Light intensity physical activity time
Baseline, 6 months and 12 months
- +20 more secondary outcomes
Study Arms (3)
Lifestyle intervention (physical activity and diet)
ACTIVE COMPARATORLifestyle (physical activity and diet) and Sleep intervention
ACTIVE COMPARATORHealth education intervention
SHAM COMPARATORInterventions
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.
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.
Participants randomized to the control group will benefit from a health education intervention in order to limit deception bias.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Grenoble University Hospital
Grenoble, 38000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie Coudurier, MD
MCoudurier3@chu-grenoble.fr
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2024
First Posted
May 22, 2024
Study Start
May 2, 2024
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2028
Last Updated
May 28, 2024
Record last verified: 2024-05