- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06626295
Exercise-snacks for Breaking the Sedentary Lifestyle and Improving the Physical Fitness of Obese Adolescents? (SNACKEX)
Exercise-snacks: an Effective Solution for Breaking the Sedentary Lifestyle and Improving the Physical Fitness of Obese Adolescents?
The management of a person with obesity involves long-term behavioral changes with a balanced diet in both quantity and quality, along with the adoption of a more active lifestyle: increasing physical activities and reducing sedentary behaviors. The school setting has been identified as a favorable environment for interventions aimed at reducing and interrupting the time adolescents spend sitting and preventing the associated negative health consequences.
Recently, very short (< 1 minute) and intense exercises, called 'exercise-snacks,' have been reported to be effective in adults for 1) improving physical fitness over 6 weeks, and 2) improving vascular function and lowering blood glucose levels over a single day. Additionally, in adolescents with diabetes, they have been shown to reduce body fat. This raises the question of whether adding 'exercise-snack' sessions to a multidimensional care program for hospitalized obese adolescents could further improve their physical fitness in the short and medium term.
The objective of this project is to compare the effects of a traditional multidimensional care program with the addition of 'exercise-snacks' to the same care program without 'exercise-snacks' on the physical fitness, body composition, vascular function, and physical activity and sedentary behaviors of obese children in the short and medium term. Forty-eight obese adolescents will be included. The 'exercise-snack' group will perform six exercise sessions per day for three weeks in addition to the standard care. The control group will receive only the standard care. Assessments of physical fitness, body composition, vascular health, and questionnaires on physical activity, sedentary behavior, and cognitive restraint will be conducted at the beginning and end of the three-week program, as well as 1 and 3 months after the end of the program.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: VINET Agnès VINET Agnès
- Phone Number: 33 4 13 95 13 44
- Email: agnes.vinet@univ-avignon.fr
Study Locations
-
-
-
Palavas-les-Flots, France
- Not yet recruiting
- Institut Saint Pierre
-
Palavas-les-Flots, France, 34250
- Recruiting
- Instiutut Saint Pierre
-
Contact:
- Dr Claire-Lise GAY, MD
- Phone Number: 33 - 4 67 07 75 00
- Email: gay.c@institut-st-pierre.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Body mass index Z-score corresponding to stage 2 obesity,
- no weight loss of more than 5% of total body weight in the past 3 months,
- parental consent
- minor's acceptance
Exclusion Criteria:
- Contraindication to physical activity
- current participation in a clinical trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: exercise-snack group
Exercise program: Adolescents in the exercise-snacks group will perform 4 "exercise-snacks" sessions per day during 3 weeks in addition to multidimensional care program. These sessions will consist of 1-min various intense supervised exercises . They will also receive information about their attitudes to physical activity. |
Adolescents in the exercise-snacks group will perform 4 "exercise-snacks" sessions per day during 3 weeks in addition to multidimensional care program.
These sessions will consist of 1-min various intense supervised exercises .
They will also receive information about their attitudes to physical activity.
|
|
No Intervention: control group
only the multidimensional care program without 'exercise-snacks'
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in aerobic fitness: predicted VO2max
Time Frame: at inclusion, at the end of the 3-weeks program and 1 and 3 month following the end of the program
|
Measured by the Spartacus 15-15 field test, an intermittent maximal running field test with prediction of VO2max: For girls: VO2max = last stage * 153.4433 + BMI * 58.64534 + âge * -2.701522-921.2878 For boys: VO2max = last stage * 153.4433 + 320.1583 + BMI * 58.64534 + âge * -2.701522-921.2878 |
at inclusion, at the end of the 3-weeks program and 1 and 3 month following the end of the program
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in fat mass
Time Frame: from inclusion to the end of the 3-weeks program and 1 and 3 month following the end of the program
|
measured by medical body composition analyzer mBCA SECA, in kg
|
from inclusion to the end of the 3-weeks program and 1 and 3 month following the end of the program
|
|
Changes in body mass index in kg/m²
Time Frame: at inclusion, at the end of the 3-weeks program and 1 and 3 month following the end of the program
|
at inclusion, at the end of the 3-weeks program and 1 and 3 month following the end of the program
|
|
|
change in carotid extra-media thickness
Time Frame: at inclusion, at the end of the 3-weeks program and 1 and 3 month following the end of the program
|
measured by echocardiography (Mylab, Esaote, Italie) and off-line analyses by CAROLAB, in mm
|
at inclusion, at the end of the 3-weeks program and 1 and 3 month following the end of the program
|
|
Changes in carotid intima-thickness
Time Frame: at inclusion, at the end of the 3-weeks program and 1 and 3 month following the end of the program
|
measured by echocardiography (Mylab, Esaote, Italie) and off-line analyses by CAROLAB, in mm
|
at inclusion, at the end of the 3-weeks program and 1 and 3 month following the end of the program
|
|
Change from baseline in carotid compliance (mm²/mmHg)
Time Frame: From inclusion to the end of the 3-weeks program and 1 and 3 month following the end of the program
|
measured by echocardiography (Mylab, Esaote, Italie) according to the variations of systolic and diastolic arterial diameters and pulse pressure (measured on the left arm by an automated system Omron)
|
From inclusion to the end of the 3-weeks program and 1 and 3 month following the end of the program
|
|
Changes in eating behaviours traits
Time Frame: at inclusion, at the end of the 3-weeks program and 1 and 3 month following the end of the program
|
measured by the Three-Factor Eating Questionnaire to assess three factors: the cognitive restraint scale (6 items), the emotional eating scale (6 items), and the uncontrolled eating scale (9 items) with a 4-point response scale. For the TFEQ scores, means are computed for each subscale and are transformed to correspond to a 0-100 scale score Higher scores indicate higher levels of restrained eating, disinhibited eating, and predisposition to hunger. |
at inclusion, at the end of the 3-weeks program and 1 and 3 month following the end of the program
|
|
change in level of habitual physical activity
Time Frame: before inclusion and before the 1 and 3-month visit
|
measured by accelerometric data using AX3, Axivity over 7-days consecutive period before inclusion and before the 1 and 3-month visit
|
before inclusion and before the 1 and 3-month visit
|
|
Changes in psychometric properties of physical activity and sedentary
Time Frame: from inclusion to the end of the 3-weeks program and 1 and 3 month following the end of the program
|
measured by a 31 items self-administered questionnaire CAPAS-Q to assess the psychometric properties of the Children and Adolescents Physical Activity (PA) and Sedentar (SB) by-Questionnaire (Fillon et al 2022) Responses are quoted from 1 to 4 for PA and from 1 to 6 for SB.
The sum of items 1, 3, 6, 8, 10, 12, and 17 exploring PA duration, the sum of items 2, 4, 7, 11, 13, and 18 exploring PA intensity, within its different contexts of practice: school PA (i.e., the sum of items 1,2,3,4,5), non-school PA (the sum of items 6 to 14), and sports and leisure PA (the sum of items 15 to 18).
The last 13 items designe to assess the SB dimension:, exploring screen ( the sum of items 2, 6, and 7) or non-screen non-screen ( the sum of items 1, 4, 5, 8, 9, 12 and 13) behaviors, the consecutive SB duration (the sum of items 3, 10 and 11) and the context of SB: school SB (the sum of items 1 to 3), non-school SB (the sum of items 4 to 11), SB during transportation (the sum of 12,13)
|
from inclusion to the end of the 3-weeks program and 1 and 3 month following the end of the program
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- AU_ISP1_2024
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.
Clinical Trials on Exercise
-
Centre Hospitalier de CorbieRecruitingExercise Training | Cardiac Rehabilitation | Exercise Intolerance | Exercise Intervention | Exercise Adaptations | HFrEF - Heart Failure With Reduced Ejection FractionFrance
-
Bitlis Eren UniversityCompletedExercise Physiology | Exercise ImmunologyTurkey (Türkiye)
-
Lindenwood UniversityIncrenovo, LLCRecruitingCognitive Function | Blood Flow | Nitric Oxide | Endurance Exercise | Exercise Performance | Exercise RecoveryUnited States
-
Hamza KucukCompletedExercise Training | Exercise PhysiologyTurkey (Türkiye)
-
Faculdade de Motricidade HumanaCompletedGreen Exercise | Indoor ExercisePortugal
-
Egas Moniz - Cooperativa de Ensino Superior, CRLCompletedAgeing | Aerobic Exercise | Resistance Exercise | Combined ExercisePortugal
-
Universidad Rey Juan CarlosCompletedEndurance Exercise | Running Performance | Exercise PhysiologySpain
-
Istanbul Sabahattin Zaim UniversityT.C. Dumlupınar ÜniversitesiCompletedExercise Ergogenics | Recovery Methods | Carnitine Ingestion | Exercise Fatigue | Exercise and RecoveryTurkey (Türkiye)
-
Hasan Kalyoncu UniversityNot yet recruiting
-
University of HawaiiKlein Buendel, Inc.CompletedMomZing Exercise Videos Online | Standard Exercise DVDUnited States
Clinical Trials on exercise-snack group
-
Weifang Medical UniversityNot yet recruiting
-
New York Institute of TechnologyActive, not recruitingMuscle Strength | Physical Endurance | Muscle PowerUnited States
-
Institut de Recherches Cliniques de MontrealCompletedType 1 Diabetes MellitusCanada
-
Pamukkale UniversityCompleted
-
Capital University of Physical Education and Sports...Not yet recruitingEffects of Exercise on Older AdultsChina
-
Penn State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedObesity | Feeding BehaviorsUnited States
-
Guy's and St Thomas' NHS Foundation TrustKing's College London; Almond Board of CaliforniaNot yet recruiting
-
Purdue UniversityCompleted
-
University of CoimbraNot yet recruitingObesity & Overweight | Aged 65 Years or OlderPortugal
-
Institut de Recherches Cliniques de MontrealCompleted