Controlled Evaluation of an Exercise Program for Overweight Adolescents

NCT06923865 | Not Yet Recruiting DMC

• 1 other identifier: Now!-Projekt, 2024-01651
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

Overweight adolescents; Youth physical activity; Motor performance in children; Impulse control and fitness; training in peer groups

Outcome Measures

Primary Outcomes (2)

• Aerobic performance

  Cardiopulmonary exercise testing (CPET) will be performed on a mechanically braked bicycle ergometer (Ergoselect 200, Ergoline GmbH, Germany). Ventilation and gas exchange will be measured breath-by-breath using a face mask connected to a Cortex Metalyzer 3B (Cortex Biophysik GmbH, Germany). Basic spirometry is conducted before testing. A 12-lead ECG (Customed GmbH, Germany) is used at rest and during exercise to monitor heart rate and detect abnormalities. CPET begins with a 3-minute resting phase and continues using one of five established protocols (Wagner et al., 2019). Participants are verbally encouraged throughout. Gas exchange values are averaged every 30 seconds. VO₂max and RERmax are recorded as peak values at or before exhaustion. Subjective exertion is assessed every 2 minutes and post-exercise using the Borg scale (Borg, 1998).

  over the time period of one year of intervention, october to october

• Strength assessment

  The measurement of isometric maximal voluntary contraction of lower extremity muscles will be performed in a seated position in a dynamometer (Isomed 2000, D. \& R. Ferstl GmbH, Hemau, Germany). This test is similar to a typical leg press commonly found in gyms. According to Maffiuletti et al. (2016) the subjects are instructed to extend their legs as fast and forceful as possible and hold the contraction for 3-5s. After a familiarization attempt, the measurement is performed three times with a rest of 45 s in between. Peak torque will be used as primary outcome.

  over the time period of one year of intervention, october to october

Secondary Outcomes (4)

• Retinal vessel Analysis

  time period of one year

• Blood pressure

  time period of one year

• Enjoyment of physical activity

  over the time period of one year of intervention, october to october

• Body composition

  over the time period of one year of intervention, october to october

Other Outcomes (11)

• Power assessment

  over the time period of one year of intervention, october to october

• Handgrip Strength

  over the time period of one year of intervention, october to october

• Acceptance and Fusion Questionnaire for Youth (AFQ-Y)

  over the time period of one year of intervention, october to october

Study Arms (2)

training group

ACTIVE COMPARATOR

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

Behavioral: training group

control group

NO INTERVENTION

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.

Interventions

training group 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.

training group

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Gesundheitsförderung Schweiz, GFCH: collaborator
• University of Basel: collaborator

Study Sites (1)

Department of Sport, Exercise and Health

Basel, 4052, Switzerland

Location

MeSH Terms

Conditions

Pediatric Obesity; Disruptive, Impulse Control, and Conduct Disorders

Interventions

Sensitivity Training Groups

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy, Group; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ralf Roth, Phd

  University of Basel, Department of Sport, Exercise and Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukas Nebiker, M.sc.

CONTACT

+41 (0)61 207 47 52; lukas.nebiker@unibas.ch

Christoph Hauser, Phd

CONTACT

+41 (0)61 207 47 47; christoph.hauser@unibas.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 11, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)