Clinical trial NCT06424847: Effects of a Lifestyle and Sleep Intervention in Non-exercising 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inactivity, Physical
Lifestyle Risk Reduction
Keywords: lifestyle intervention
sleep intervention
physical activity
behavior change techniques
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Steps per day
timeFrame: 6 months after randomization
measure: Health-related quality of life
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Subjective sleep quality
timeFrame: Baseline, 6 months and 12 months
measure: Sleep duration
timeFrame: Baseline, 6 months and 12 months
measure: Sleep quality
timeFrame: Baseline, 6 months and 12 months
measure: Modrate to vigorous intensity physical activity time
timeFrame: Baseline, 6 months and 12 months
measure: Light intensity physical activity time
timeFrame: Baseline, 6 months and 12 months
measure: Vigorous intensity physical activity time
timeFrame: Baseline, 6 months and 12 months
measure: Sedentary time
timeFrame: Baseline, 6 months and 12 months
measure: Cardiorespiratory fitness (VO2peak)
timeFrame: Baseline, 6 months and 12 months
measure: 6 minute walk test distance
timeFrame: Baseline, 6 months and 12 months
measure: 24-hr systolic and diastolic blood pressure
timeFrame: Baseline, 6 months and 12 months
measure: Health-related quality of life
timeFrame: Baseline, 6 months and 12 months
measure: Body composition
timeFrame: Baseline, 6 months and 12 months
measure: Grip strength
timeFrame: Baseline, 6 months and 12 months
measure: Quality of life SF-36
timeFrame: Baseline, 6 months and 12 months
measure: Anxiety symptoms
timeFrame: Baseline, 6 months and 12 months
measure: Depressive symptoms
timeFrame: Baseline, 6 months and 12 months
measure: Mental well-being
timeFrame: Baseline, 6 months and 12 months
measure: Motivation toward physical activity
timeFrame: Baseline, 6 months and 12 months
measure: Social deprivation
timeFrame: Baseline, 6 months and 12 months
measure: Eating behavior
timeFrame: Baseline, 6 months and 12 months
measure: Insomnia Severity
timeFrame: Baseline, 6 months and 12 months
measure: Subjective sleepiness
timeFrame: Baseline, 6 months and 12 months
measure: Attitude towards physical activity practice
timeFrame: Baseline, 6 months and 12 months
measure: Self-efficacy
timeFrame: Baseline, 6 months and 12 months
measure: Subjective norms
timeFrame: Baseline, 6 months and 12 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University Hospital
Study officials:
affiliation: MCoudurier3@chu-grenoble.fr
name: Marie Coudurier, MD
role: PRINCIPAL_INVESTIGATOR
References: