Obese AdolescentsSNACKEXNCT06626295
Exercise-snacks for Breaking the Sedentary Lifestyle and Improving the Physical Fitness of Obese Adolescents?
A study testing exercise-snack group in people with Obese Adolescents and Sedentary Time, run by University of Avignon at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Obese Adolescents, Sedentary Time, Exercise
- What is being tested?
- exercise-snack group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Sep 2024to Jun 2026
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Contraindication to physical activity
- current participation in a clinical trial
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Instiutut Saint Pierre
Palavas-les-Flots, 34250
Dr Claire-Lise GAY, MD, 33 - 4 67 07 75 00, gay.c@institut-st-pierre.fr
- Not yet recruiting
Institut Saint Pierre
Palavas-les-Flots
About this study
Official title: 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.
- Conditions
- Obese Adolescents, Sedentary Time, Exercise
- Being tested
- exercise-snack group
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise-snack groupOther
Adolescents in the exercise-snacks group will perform 4 \&amp;amp;#34;exercise-snacks\&amp;amp;#34; 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.
| Study group | Role | What they receive |
|---|---|---|
| exercise-snack group | Experimental | 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. Receives: Other: exercise-snack group |
| control group | No intervention | only the multidimensional care program without 'exercise-snacks' |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in aerobic fitness: predicted VO2max
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
Measured: at inclusion, at the end of the 3-weeks program and 1 and 3 month following the end of the program
Secondary outcomes (8)
Changes in fat mass
measured by medical body composition analyzer mBCA SECA, in kg
Measured: 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
Measured: 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
measured by echocardiography (Mylab, Esaote, Italie) and off-line analyses by CAROLAB, in mm
Measured: 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
measured by echocardiography (Mylab, Esaote, Italie) and off-line analyses by CAROLAB, in mm
Measured: 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)
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)
Measured: 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
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.
Measured: at inclusion, at the end of the 3-weeks program and 1 and 3 month following the end of the program
Changes in psychometric properties of physical activity and sedentary
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)
Measured: from inclusion to 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
measured by accelerometric data using AX3, Axivity over 7-days consecutive period before inclusion and before the 1 and 3-month visit
Measured: before inclusion and before the 1 and 3-month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start9 Sep 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese AdolescentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Avignon
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Saint Pierre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626295
- Sponsor's protocol ID
- AU_ISP1_2024
- Acronym
- SNACKEX
- Status last verified
- Apr 2026
- First submitted
- 23 Sep 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-snacks: an Effective Solution for Breaking the Sedentary Lifestyle and Improving the Physical Fitness of Obese Adolescents?
- ClinicalTrials.gov ID
- NCT06626295
- Acronym / sponsor ID
- SNACKEX / AU_ISP1_2024
- Conditions
- Obese Adolescents, Sedentary Time, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of AvignonUniversity, hospital or other
- Collaborators
- Institut Saint Pierre
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise-snack group | Experimental | Other: exercise-snack groupExercise 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. |
| control group | No intervention | –only the multidimensional care program without 'exercise-snacks' |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Contraindication to physical activity
- current participation in a clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise-snack groupAdolescents in the exercise-snacks group will perform 4 \&amp;amp;#34;exercise-snacks\&amp;amp;#34; 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. | Other | exercise-snack group |
Primary outcome
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
8 secondary outcomes
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
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
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
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
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
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
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
change in level of habitual physical activity
Time frame: before inclusion and before the 1 and 3-month visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise-snack group in people with Obese Adolescents and Sedentary Time, run by University of Avignon at 2 sites 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 4 inclusion and 2 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 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 VINET Agnès VINET Agnès (33 4 13 95 13 44, agnes.vinet@univ-avignon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2026.