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Inactivity, PhysicalSPIRAL+NCT06424847

Effects of a Lifestyle and Sleep Intervention in Non-exercising Adults

A study testing Lifestyle intervention (physical activity and diet), Lifestyle (physical activity and diet) and Sleep intervention and Health education intervention in people with Inactivity, Physical and Lifestyle Risk Reduction, run by University Hospital, Grenoble at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Lifestyle intervention (physical activity and diet), Lifestyle (physical activity and diet) and Sleep intervention and Health education intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
201 participants
Where
1 siteFrance
Study dates
2 May 2024to 1 May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Monique Mendelson, PhD contact

+33 4 76 76 72 26

mmendelson@chu-grenoble.fr

Marie Coudurier, MD contact

MCoudurier3@chu-grenoble.fr

France1 site, 1 recruiting
  • Grenoble University Hospital

    Grenoble, 38000

    Monique Mendelson, PhD, mmendelson@chu-grenoble.fr

    Marie Coudurier, MD

    Recruiting

Other trials in France

About this study

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

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.

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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.

Being tested
Lifestyle intervention (physical activity and diet), Lifestyle (physical activity and diet) and Sleep intervention, Health education intervention
Keywords
lifestyle intervention, sleep intervention, physical activity, behavior change techniques
Medical subject headings
Sedentary Behavior, Risk Reduction Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle intervention (physical activity and diet)Behavioural

    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 interventionBehavioural

    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 interventionBehavioural

    Participants randomized to the control group will benefit from a health education intervention in order to limit deception bias.

Study groups in NCT06424847
Study groupRoleWhat they receive
Lifestyle intervention (physical activity and diet)Active comparatorNot described
Receives: Behavioral: Lifestyle intervention (physical activity and diet)
Lifestyle (physical activity and diet) and Sleep interventionActive comparatorNot described
Receives: Behavioral: Lifestyle (physical activity and diet) and Sleep intervention
Health education interventionSham comparatorNot described
Receives: Behavioral: Health education intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Steps per day

    Measured using an activity monitor (Actigraph)

    Measured: 6 months after randomization

  2. 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).

    Measured: 6 months after randomization

Secondary outcomes (25)
  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.

    Measured: Baseline, 6 months and 12 months

  2. Sleep duration

    Measured using an activity monitor (Actigraph GT3X) and Sunrise sleep

    Measured: Baseline, 6 months and 12 months

  3. Sleep quality

    Measured using an activity monitor (Actigraph GT3X) and Sunrise

    Measured: Baseline, 6 months and 12 months

  4. Modrate to vigorous intensity physical activity time

    Time spent in moderate-to-vigorous physical activity measured by a physical activity monitor, Actigraph GT3X

    Measured: Baseline, 6 months and 12 months

  5. Light intensity physical activity time

    Time spent in light intensity physical activity measured by a physical activity monitor, Actigraph GT3X

    Measured: Baseline, 6 months and 12 months

  6. Vigorous intensity physical activity time

    Time spent in vigorous intensity physical activity measured by a physical activity monitor, Actigraph GT3X

    Measured: Baseline, 6 months and 12 months

  7. Sedentary time

    Sedentary time measured by a physical activity monitor Actigraph GT3X

    Measured: Baseline, 6 months and 12 months

  8. Cardiorespiratory fitness (VO2peak)

    Cardiorespiratory stress test

    Measured: Baseline, 6 months and 12 months

  9. 6 minute walk test distance

    Six-minute walk test: This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD)

    Measured: Baseline, 6 months and 12 months

  10. 24-hr systolic and diastolic blood pressure

    Measured using an ambulatory BP device

    Measured: Baseline, 6 months and 12 months

  11. 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).

    Measured: Baseline, 6 months and 12 months

  12. Body composition

    Measured using bio-electrical impedance

    Measured: Baseline, 6 months and 12 months

  13. Grip strength

    Measured using a dynamometer

    Measured: Baseline, 6 months and 12 months

  14. Quality of life SF-36

    The 36-Item Short Form Health Survey questionnaire measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Measured: Baseline, 6 months and 12 months

  15. Anxiety symptoms

    General Anxiety Disorder-7 (GAD-7) questionnaire. The score is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21.

    Measured: Baseline, 6 months and 12 months

  16. Depressive symptoms

    Patient Health Questionnaire-9 (PHQ-9). Each item is evaluated on a severity scale ranging from 0 to 3 where the respondent is asked to rate how often each symptom occurred over the last 2 weeks (0-not at all; 1-several days; 2-more than half of the days or 3-nearly every day), yielding a total score ranging from 0-27.

    Measured: Baseline, 6 months and 12 months

  17. Mental well-being

    Warwick-Edinburgh Mental Wellbeing Scale. The Likert scale represents a score for each item from 1 to 5 respectively, giving a minimum score of 14 and maximum score of 70. All items are scored positively. The overall score for the WEMWBS is calculated by totalling the scores for each item, with equal weights.

    Measured: Baseline, 6 months and 12 months

  18. Motivation toward physical activity

    Motivation Scale towards Health-Oriented Physical Activity questionnaire. A higher score indicates higher motivation towards physical activity.

    Measured: Baseline, 6 months and 12 months

  19. Social deprivation

    Social deprivation score. This questionnaire is designed to assess the level of precariousness by the means of 11 binary items. Among these 11 items, two are very frequent in material deprivation scales: items #4-5. Six are related to social deprivation: items #1, #3, #6-9. One is related to health and financial difficulties: item #1. The last two [#10-11] are specific to precariousness scales. The final score can vary from 0 (no precariousness), to 100 (extreme precariousness), each item having its own weight.

    Measured: Baseline, 6 months and 12 months

  20. Eating behavior

    The Dutch Eating Behavior Questionnaire (DEBQ) is a 33-item self-report questionnaire that is aimed to assess three distinct eating behaviors in adults: (1) emotional eating, (2) external eating, and (3) restrained eating. Items on the DEBQ range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior.

    Measured: Baseline, 6 months and 12 months

  21. Insomnia Severity

    Insomnia Severity Index. The total score is the sum of all seven items. Total score ranges from 0-28. A higher score indicates more symptoms of insomnia.

    Measured: Baseline, 6 months and 12 months

  22. Subjective sleepiness

    Epworth Sleepiness Score. The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.

    Measured: Baseline, 6 months and 12 months

  23. Attitude towards physical activity practice

    This scale measures the main psychological predictors of physical activity according to the theory of planned behaviour. Attitude is measured by 5 items. A higher score indicates more a favorable attitude.

    Measured: Baseline, 6 months and 12 months

  24. Self-efficacy

    This scale measures the main psychological predictors of physical activity according to the theory of planned behaviour. Self-efficacy is measured by 3 items, a higher score indicates higher self-efficacy.

    Measured: Baseline, 6 months and 12 months

  25. Subjective norms

    This scale measures the main psychological predictors of physical activity according to the theory of planned behaviour. Subjective norms is measured by 2 items, a higher score indicates more favorable subjective norms.

    Measured: Baseline, 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2024
  2. Study start2 May 2024
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
201 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06424847
Sponsor's protocol ID
SPIRAL+
Acronym
SPIRAL+
Status last verified
May 2024
First submitted
25 Apr 2024
Last updated
28 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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 Public Health. 2026 Mar 13;26(1):1297. doi: 10.1186/s12889-026-26959-4.

    PubMed 41826924

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle intervention (physical activity and diet), Lifestyle (physical activity and diet) and Sleep intervention and Health education intervention in people with Inactivity, Physical and Lifestyle Risk Reduction, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Monique Mendelson, PhD (+33 4 76 76 72 26, mmendelson@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Steps per day (time frame: 6 months after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06424847, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.

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