Effects of a Lifestyle and Sleep Intervention in Non-exercising Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lifestyle intervention (physical activity and diet), Lifestyle (physical activity and diet) and Sleep intervention, Health education intervention.
- Who it may be relevant to
- Registry conditions: Inactivity, Physical, Lifestyle Risk Reduction. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Behavioral 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 rea - Behavioral 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 - Behavioral Health education intervention
Participants randomized to the control group will benefit from a health education intervention in order to limit deception bias.
Primary outcome measures
- Steps per day [Time frame: 6 months after randomization]
- Health-related quality of life [Time frame: 6 months after randomization]
Secondary outcome measures (12)
- Subjective sleep quality [Time frame: Baseline, 6 months and 12 months]
- Sleep duration [Time frame: Baseline, 6 months and 12 months]
- Sleep quality [Time frame: Baseline, 6 months and 12 months]
- Modrate to vigorous intensity physical activity time [Time frame: Baseline, 6 months and 12 months]
- Light intensity physical activity time [Time frame: Baseline, 6 months and 12 months]
- Vigorous intensity physical activity time [Time frame: Baseline, 6 months and 12 months]
- Sedentary time [Time frame: Baseline, 6 months and 12 months]
- Cardiorespiratory fitness (VO2peak) [Time frame: Baseline, 6 months and 12 months]
- 6 minute walk test distance [Time frame: Baseline, 6 months and 12 months]
- 24-hr systolic and diastolic blood pressure [Time frame: Baseline, 6 months and 12 months]
- Health-related quality of life [Time frame: Baseline, 6 months and 12 months]
- Body composition [Time frame: Baseline, 6 months and 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Grenoble University Hospital — Grenoble
Publications
- Mendelson M, Coudurier M, Doutreleau S, Guinot M, Flore P, Bailly S, Baillieul S, Destors M, Tamisier R, Pepin JL, Tessier D, Roustit M, Manceau M, Chalabaev A, Verges S. Study protocol for a theory-informed randomized controlled trial of a lifestyle and sleep intervention to improve quality of life and physical activity in inactive adults: the SleeP exercIse nutRition heALth+ SPIRAL+ study. BMC P PMID 41826924
Identifiers
NCT: NCT06424847 · SPIRAL+