Controlled Evaluation of an Exercise Program for Overweight Adolescents

NCT ID: NCT06923865

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2029-12-31

Brief Summary

Physical activity decreases as young people get older, especially during the shift from early to late adolescence. Unfortunately, around 81% of school-aged children worldwide between the ages of 11 and 17 do not meet the recommendation of at least one hour of physical activity per day - and this is also true in Switzerland. Not being active enough, whether normal weight or overweight, can lead to long-term health problems and is a major factor in becoming overweight over time. This results in healthcare costs and negatively affects quality of life. Supporting physical activity in overweight youth requires well-rounded, thoughtful programs.

The investigators studying the impact of the movement programs now! and now!+ on the physical activity and health of young people. The goal is to look at both physical and mental changes equally.

Taking part in this study involves minimal physical or mental risk for the participants. These small risks from the testing methods and activities are taken into account in how the program is explained and carried out.

The benefits for the participants - feeling healthier and fitter physically, and more confident and capable mentally - clearly outweigh any potential risks, thanks to the additional, guided, and personalized exercise program.

The participants take part in the now! and now!+ exercise programs run by the Basel-Stadt Sports Office and the DSBG. now! is a 90-minute group session with up to 14 young people, while now!+ is a 90-minute small-group session with 2 to 4 participants. Both programs take place once a week over a 12-month period and pause during school holidays (38 training weeks in total).

Each session includes a warm-up, a strength or endurance training block, and a coordination phase. The program is modular and adapted to the physical and personal needs of each participant. This ensures that overweight adolescents are not overstrained and don't develop symptoms like pain, frustration, or lack of motivation (Behringer et al., 2011), while still allowing for a training stimulus that supports physical improvement.

The results of the evaluations are directly used to improve and further develop the exercise program. The overall project includes three rounds, each consisting of one year of training and three test sessions, each lasting about two hours. The now! and now!+ programs are held weekly for a total of 38 weeks per year, with breaks during school holidays.

Each of the three test sessions includes the same set of assessments (see "Study Intervention") and follows a set order: The process begins with measuring body size and blood pressure, followed by a static retinal vessel analysis. After these medical checks, participants do a 5-minute warm-up on a stationary bike at a set resistance level. Then, strength tests are performed: knee extension on the IsoMed 2000, handgrip strength, and jump power on the Leonardo force plate. The endurance test using spiroergometry marks the end of the physical assessments.

Finally, impulse control is tested, and participants complete a set of questionnaires. At the end of the session, each participant is given an actigraph (a small motion sensor worn on the body) to track their physical activity over the following seven days.

Conditions

Adolescent; Pediatric Obesity; Exercise Therapy; Health Promotion; Program Evaluation; Impulse Control Disorders; Quality of Life; Retinal Vessels; Strength Training Effects; Aerobic Capacity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

training group

training group: Two peer-group sessions per week, each including at least 90 minutes of training/workout involving moderate to vigorous physical activity.

Group Type: ACTIVE_COMPARATOR

training group

Intervention Type: BEHAVIORAL

Participants in training group are invited to take part in two structured training sessions per week, each lasting 90 minutes:

One session takes place in a larger group setting, where participants engage in physical activities and games together.

The second session is held in a small group format with 1-2 peers-either friends the participant already knows or peers they meet during the larger group session.

Each training session is supervised by a qualified instructor and includes:

Fun, game-based activities

Short workouts aimed at improving fitness

A focus on social interaction, enjoyment, and participation

The sessions are designed to be supportive, engaging, and motivating, with the goal of increasing physical activity in a positive group environment.

control group

There is no intervention in the control group. The control group only receives the WHO physical activity recommendations as well as the results of the assessments in the form of a detailed health report.

Control arm: Observation of physical and psychological development without additional intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

training group

Participants in training group are invited to take part in two structured training sessions per week, each lasting 90 minutes:

One session takes place in a larger group setting, where participants engage in physical activities and games together.

The second session is held in a small group format with 1-2 peers-either friends the participant already knows or peers they meet during the larger group session.

Each training session is supervised by a qualified instructor and includes:

Fun, game-based activities

Short workouts aimed at improving fitness

A focus on social interaction, enjoyment, and participation

The sessions are designed to be supportive, engaging, and motivating, with the goal of increasing physical activity in a positive group environment.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• BMI above the 90th percentile for their age and gender (WHO reference table)
• Deficits in movement motivation and motor skills
• No health complaints or movement-restricting conditions
• No health risks for maximal exertion
• Ability to verbally communicate pain or discomfort
• Unremarkable PAR-Q questionnaire
• Signed parental consent form

Exclusion Criteria

• Acute or chronic illness
• Inability to follow the study procedures (e.g., language barriers, psychological disorders)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gesundheitsförderung Schweiz, GFCH

UNKNOWN

Sponsor Role: collaborator

University of Basel

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralf Roth, Phd

Role: PRINCIPAL_INVESTIGATOR

University of Basel, Department of Sport, Exercise and Health

Locations

Department of Sport, Exercise and Health

Basel, , Switzerland

Countries

Switzerland

Central Contacts

Lukas Nebiker, M.sc.

Role: CONTACT

lukas.nebiker@unibas.ch

+41 (0)61 207 47 52

Christoph Hauser, Phd

Role: CONTACT

christoph.hauser@unibas.ch

+41 (0)61 207 47 47

Other Identifiers

Now!-Projekt, 2024-01651

Identifier Type: -

Identifier Source: org_study_id