- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06788041
EFFECT OF HAMMAM EXPERIENCE ON GENERAL HEALTH AND PERCEIVED WELL-BEING
ANALYSIS OF THE EFFECT OF HAMMAM EXPERIENCE ON GENERAL HEALTH AND PERCEIVED WELL-BEING COMPARED TO MASSAGE AND PLACEBO : A RANDOMIZED CROSS-SECTIONAL STUDY.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Granada, Spain, 18016
- University of Granada
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Men and women (50%) 25-65 years old
- No metabolic risk.
- Resident in the province of Granada.
- Socio-economic level: medium-high
- Experience in self-care
- Spanish level C2
Exclusion Criteria:
- Pregnancy
- Participation in treatments and relaxation techniques or taking medication (anxiolytics) frequently (≥ 1 per week) in the last 12 months
- Medical situations limiting participation in the study: acute musculoskeletal pathologies (fractures, wounds, etc.) or local inflammatory processes, diagnosed psychiatric disease, vascular diseases (thrombosis), contagious diseases, fever, thermoregulation problems, incontinence, craniocerebral trauma or infarction (< 6 months), thermal allergies, hypertension, or any uncontrolled systemic disease).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1 (ABC)
Participants in this arm will rotate through three treatments (Treatment A Hamman experience and massage, Treatment B massage only, and Treatment C placebo) in a randomized sequence.
Each treatment will be separated by a washout period to minimize carryover effects.
All participants will experience each treatment at different periods, serving as their own control.
|
There will be a circuit in the Hammam Al Andalus baths with baths in all pools (warm, hot or cold water) and sauna for 30 minutes.
The time in each pool will be determined by the sensation and tolerance of each participant.
In addition, participants will receive foam with aromatic oils on the participant's body (arms, trunk and legs).
This foam will be left for about 10 minutes on the participant's body, while a manual body therapy is performed.
The force to be applied will be very weak, a superficial rubbing will be performed to prepare the tissue, followed by a maintained pressure and then sliding pressures are performed.
The application time should not exceed 15 minutes.
Other Names:
Duration of 45 minutes.
A complete dorsal and ventral body massage will be performed, with superficial maneuvers at a slow pace of traditional massage.
The person will be instructed to stay for 45 minutes during which he/she will receive different electrotherapy techniques with the devices disconnected, a mobile device that simulates a beep will be placed so that the patient believes that the device is connected.
|
|
Experimental: Arm 2 (ACB)
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There will be a circuit in the Hammam Al Andalus baths with baths in all pools (warm, hot or cold water) and sauna for 30 minutes.
The time in each pool will be determined by the sensation and tolerance of each participant.
In addition, participants will receive foam with aromatic oils on the participant's body (arms, trunk and legs).
This foam will be left for about 10 minutes on the participant's body, while a manual body therapy is performed.
The force to be applied will be very weak, a superficial rubbing will be performed to prepare the tissue, followed by a maintained pressure and then sliding pressures are performed.
The application time should not exceed 15 minutes.
Other Names:
Duration of 45 minutes.
A complete dorsal and ventral body massage will be performed, with superficial maneuvers at a slow pace of traditional massage.
The person will be instructed to stay for 45 minutes during which he/she will receive different electrotherapy techniques with the devices disconnected, a mobile device that simulates a beep will be placed so that the patient believes that the device is connected.
|
|
Experimental: ARM 3 (BAC)
|
There will be a circuit in the Hammam Al Andalus baths with baths in all pools (warm, hot or cold water) and sauna for 30 minutes.
The time in each pool will be determined by the sensation and tolerance of each participant.
In addition, participants will receive foam with aromatic oils on the participant's body (arms, trunk and legs).
This foam will be left for about 10 minutes on the participant's body, while a manual body therapy is performed.
The force to be applied will be very weak, a superficial rubbing will be performed to prepare the tissue, followed by a maintained pressure and then sliding pressures are performed.
The application time should not exceed 15 minutes.
Other Names:
Duration of 45 minutes.
A complete dorsal and ventral body massage will be performed, with superficial maneuvers at a slow pace of traditional massage.
The person will be instructed to stay for 45 minutes during which he/she will receive different electrotherapy techniques with the devices disconnected, a mobile device that simulates a beep will be placed so that the patient believes that the device is connected.
|
|
Experimental: Arm 4 (BCA)
|
There will be a circuit in the Hammam Al Andalus baths with baths in all pools (warm, hot or cold water) and sauna for 30 minutes.
The time in each pool will be determined by the sensation and tolerance of each participant.
In addition, participants will receive foam with aromatic oils on the participant's body (arms, trunk and legs).
This foam will be left for about 10 minutes on the participant's body, while a manual body therapy is performed.
The force to be applied will be very weak, a superficial rubbing will be performed to prepare the tissue, followed by a maintained pressure and then sliding pressures are performed.
The application time should not exceed 15 minutes.
Other Names:
Duration of 45 minutes.
A complete dorsal and ventral body massage will be performed, with superficial maneuvers at a slow pace of traditional massage.
The person will be instructed to stay for 45 minutes during which he/she will receive different electrotherapy techniques with the devices disconnected, a mobile device that simulates a beep will be placed so that the patient believes that the device is connected.
|
|
Experimental: Arm 5 (CAB)
|
There will be a circuit in the Hammam Al Andalus baths with baths in all pools (warm, hot or cold water) and sauna for 30 minutes.
The time in each pool will be determined by the sensation and tolerance of each participant.
In addition, participants will receive foam with aromatic oils on the participant's body (arms, trunk and legs).
This foam will be left for about 10 minutes on the participant's body, while a manual body therapy is performed.
The force to be applied will be very weak, a superficial rubbing will be performed to prepare the tissue, followed by a maintained pressure and then sliding pressures are performed.
The application time should not exceed 15 minutes.
Other Names:
Duration of 45 minutes.
A complete dorsal and ventral body massage will be performed, with superficial maneuvers at a slow pace of traditional massage.
The person will be instructed to stay for 45 minutes during which he/she will receive different electrotherapy techniques with the devices disconnected, a mobile device that simulates a beep will be placed so that the patient believes that the device is connected.
|
|
Experimental: Arm 6 (CBA)
|
There will be a circuit in the Hammam Al Andalus baths with baths in all pools (warm, hot or cold water) and sauna for 30 minutes.
The time in each pool will be determined by the sensation and tolerance of each participant.
In addition, participants will receive foam with aromatic oils on the participant's body (arms, trunk and legs).
This foam will be left for about 10 minutes on the participant's body, while a manual body therapy is performed.
The force to be applied will be very weak, a superficial rubbing will be performed to prepare the tissue, followed by a maintained pressure and then sliding pressures are performed.
The application time should not exceed 15 minutes.
Other Names:
Duration of 45 minutes.
A complete dorsal and ventral body massage will be performed, with superficial maneuvers at a slow pace of traditional massage.
The person will be instructed to stay for 45 minutes during which he/she will receive different electrotherapy techniques with the devices disconnected, a mobile device that simulates a beep will be placed so that the patient believes that the device is connected.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance of the autonomic nervous system upon waking
Time Frame: Measurement 1: Upon waking on the session day (6:00-7:00 a.m.); Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 4: Upon waking the day after session (6:00-7:00 a.m.); Measurement 5: 2
|
Evaluated through heart rate variability upon waking up.
It will always be performed under the same conditions in an unlit, quiet environment without noise/distractions, with the person in supine position and after emptying the bladder.
A total time of 5 min will be recorded through H-10 polar band.
|
Measurement 1: Upon waking on the session day (6:00-7:00 a.m.); Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 4: Upon waking the day after session (6:00-7:00 a.m.); Measurement 5: 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep satisfaction
Time Frame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
|
Assessed through a Likert scale in which 0 corresponds to the option "Not all all satisfactory" and 10 with "Very satisfactory"
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Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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Hours of sleep
Time Frame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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Assessed through an open question in which participants are asked "What time did you go to bed to sleep?", "What time did you wake up in the morning?" and "How many hours and minutes do you think you slept in total at night?"
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Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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Perception of well-being
Time Frame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
|
Assessed with the EBS-8 subjective well-being scale, which assesses the two components of well-being: life satisfaction and positive affect and with a visual analog scale 0-10.
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Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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Mood
Time Frame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
|
The Mood Rating Scale (EVEA) will be used, which evaluates mood states with a range from 0 to 10 and as a time reference "right now".
It consists of 4 subscales: sadness-depression, anxiety, anger-hostility and joy.
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Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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Mental agility
Time Frame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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Assessed by the "Trail Marking Test", which assesses t used to evaluate attention, flexibility of thought and visuospatial ability.
It consists of two parts.
In both cases, the subject will need a pencil and the evaluator a stopwatch, counting the execution time for each of the parts as soon as the pertinent indications have been given.
In part A, the participant will join in ascending order all the numbers from 1 to 25 arranged on a sheet of paper.
In exercise B, the process will be repeated, but alternating letters and numbers in alphanumeric order.
In both cases, the time spent will be quantified.
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Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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Distress
Time Frame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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Assessed through a distress thermometer, a likert scale in which 0 corresponds to the option "No distress" and 10 with "Extreme distress"
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Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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Flexibility
Time Frame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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The "sit and reach" test will be performed, for the evaluation of flexibility in which the subject, who is seated on the edge of a chair (placed against a wall for safety reasons), and one foot resting on the sleep, will extend the other leg forward with the knee straight, the heel resting on the sleep and the ankle at 90º, placing one hand on top of the other with the tips of the central fingers equal.
The participant will be instructed to inhale and, on exhalation, extend the hand forward toward the toes by bending at the hip.
The distance will be measured between the fingertips and toes so that, if the fingertips touch the toes, the score is 0, if they do not touch, the resulting distance in cm will be negative and, if they overlap, we are talking about a distance in cm positive.
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Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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Functional capacity
Time Frame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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With the sit-to-stand test 30 seconds, which measures how many times a person can transition from sitting in a chair to standing and back to sitting within 30 seconds.
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Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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Fatigue
Time Frame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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After completing the 30-second sit-to-stand test, participants rate their perceived level of fatigue using the Borg CR10 scale.
This scale ranges from 0 (no fatigue at all) to 10 (extreme fatigue) and provides a subjective measure of exertion following the activity.
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Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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Overall stress regulation
Time Frame: Measurement 1: Upon waking on the session day (6:00-7:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 4: Upon waking the day after session (6:00-7:00 a.m.).
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Salivary samples will be collected first thing in the morning, using a timer and ensuring the entire sample is collected within three minutes. Without ingestion of caffeine and/or stimulant substances 12 hours before, as well as with complete oral hygiene (dental brushing and use of mouthwash, preferably) the night before. Salivary samples (400µL) will be collected in specific collection kits for 2ml salivary sample and cryovials (Salimetrics, LLC, Carlsbad, United States), to proceed to their subsequent immediate freezing at -80ºC until the pertinent analysis of cortisol through ELISA is performed. |
Measurement 1: Upon waking on the session day (6:00-7:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 4: Upon waking the day after session (6:00-7:00 a.m.).
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Systolic blood pressure
Time Frame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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Measured with the patient seated after at least 10 minutes of rest using a sphygmomanometer.
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Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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Diastolic blood pressure
Time Frame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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Measured with the patient seated after at least 10 minutes of rest using a sphygmomanometer.
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Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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Heart rate
Time Frame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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Measured with the patient seated after at least 10 minutes of rest using a sphygmomanometer
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Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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Blood oxygen saturation
Time Frame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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Measured using a pulse oximeter placed on the fingertip, ensuring the patient is seated and at rest for at least 10 minutes prior to measurement.
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Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attitude and beliefs towards holistic treatment
Time Frame: Measurement 0: At enrollment
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Through the Complementary and Alternative Medicine Health Belief Questionnaire (CHBQ), validated to Spanish.It has 10 items and addresses perception of the effectiveness of alternative therapies; willingness to use holistic treatments; and trust in complementary medicine practitioners.
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Measurement 0: At enrollment
|
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Previous experience participating in holistic therapeutic modalities.
Time Frame: Measurement 0: At enrollment
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Assessed through a yes/no questionnaire to determine prior experiences, followed by an open-ended question to record the type of modality if applicable
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Measurement 0: At enrollment
|
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Level of perceived stress
Time Frame: Measurement 0: At enrollment
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The Perceived Stress Scale (PSS-10) is a self-assessment tool used to measure the level of perceived stress in individuals in his or her life during the past month.
The scale consists of 10 questions that explore different aspects of perceived stress, such as how often individuals feel that their life is out of control, feel nervousness, or are unable to cope with their responsibilities.
The total score is obtained by summing the item responses.
Some questions are positively worded and are reverse scored.
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Measurement 0: At enrollment
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Resilience
Time Frame: Measurement 0: At enrollment
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The Connor-Davidson Resilience Scale (CD-RISC) is a self-assessment tool that measures a person's ability to overcome adversity.
It is composed of 25 items that are answered on a 5-point Likert scale, ranging from 0 (never) to 4 (almost always).
Total scores can range from 0 to 100, with higher scores indicating greater resilience.
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Measurement 0: At enrollment
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Age
Time Frame: Measurement 0: At enrollment
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Will be collected using an open-ended questionnaire where participants will provide their exact age
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Measurement 0: At enrollment
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Place of Residence
Time Frame: Measurement 0: At enrollment
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Will be collected using an open-ended questionnaire where participants will provide their Place of Residence
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Measurement 0: At enrollment
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Employment status
Time Frame: Measurement 0: At enrollment
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Will be assessed through a multiple-choice questionnaire, allowing participants to select the most appropriate response for their situation.
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Measurement 0: At enrollment
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Marital Status
Time Frame: Measurement 0: At enrollment
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Will be assessed through a multiple-choice questionnaire, allowing participants to select the most appropriate response for their situation.
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Measurement 0: At enrollment
|
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Level of Education
Time Frame: Measurement 0: At enrollment
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Will be assessed through a multiple-choice questionnaire, allowing participants to select the most appropriate response for their situation.
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Measurement 0: At enrollment
|
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Family Income
Time Frame: Measurement 0: At enrollment
|
Will be collected using a range-based question, where participants will indicate the income bracket that best reflects their household's monthly or annual income
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Measurement 0: At enrollment
|
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Height
Time Frame: Measurement 0: At enrollment
|
Measured using a calibrated stadiometer with participants standing upright and barefoot
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Measurement 0: At enrollment
|
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Weight
Time Frame: Measurement 0: At enrollment
|
Measured using digital scale, with participants standing barefoot, and in light clothing.
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Measurement 0: At enrollment
|
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Waist Circumference
Time Frame: Measurement 0: At enrollment
|
Measured using a non-stretchable tape, ensuring standard anatomical landmarks are used: between last ribs and iliac creast, at the narrowest point
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Measurement 0: At enrollment
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Hip Circumference
Time Frame: Measurement 0: At enrollment
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Measured using a non-stretchable tape, ensuring standard anatomical landmarks are used: above the greater trochanter
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Measurement 0: At enrollment
|
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Waist-Hip Ratio
Time Frame: Measurement 0: At enrollment
|
Calculated by dividing waist circumference by hip circumference
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Measurement 0: At enrollment
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Drug consumption
Time Frame: Measurement 0: At enrollment
|
These behaviors will be assessed through a structured questionnaire, including frequency and quantity of use over the past months.
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Measurement 0: At enrollment
|
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Sedentary Behavior
Time Frame: Measurement 0: At enrollment
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Measured using questions about time spent sitting or reclining during typical weekdays and weekends, excluding sleep hours
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Measurement 0: At enrollment
|
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Physical Activity Levels
Time Frame: Measurement 0: At enrollment
|
Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ), which captures the type, frequency, and duration of physical activities performed weekly, categorized into light, moderate, and vigorous intensity levels.
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Measurement 0: At enrollment
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HAM24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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