NCT06626295

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Sep 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Sep 2024Jun 2026

Study Start

First participant enrolled

September 9, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

September 23, 2024

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    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

    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

    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

    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)

    From inclusion to the end of the 3-weeks program and 1 and 3 month following the end of the program

  • +3 more secondary outcomes

Study Arms (2)

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.

Other: exercise-snack group

control group

NO INTERVENTION

only the multidimensional care program without 'exercise-snacks'

Interventions

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.

exercise-snack group

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Contraindication to physical activity
  • current participation in a clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Instiutut Saint Pierre

Palavas-les-Flots, 34250, France

RECRUITING

Institut Saint Pierre

Palavas-les-Flots, France

NOT YET RECRUITING

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

VINET Agnès VINET Agnès

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2024

First Posted

October 3, 2024

Study Start

September 9, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations