MedTrace Logo

Oxfordshire Sedentariness, Obesity & Cardiometabolic Risk in Adolescents - a Trial of Exercise in Schools

NCT04118543 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2021-08-12

No results posted yet for this study

Summary

Obesity is a major cardiovascular disease (CVD) risk factor that is rising fastest in children. Prevention of its damaging effects should begin earlier before they become irreversible. Pilot data identified novel markers of cardiometabolic dysfunction that may be better than body mass index at stratifying risk and as targets for CVD prevention in the young. Advanced imaging, blood tests and a meal-challenge will be used to comprehensively characterise how early metabolic dysfunction (liver and muscle fat, insulin resistance) affects cardiovascular health (arterial stiffness, myocardial energetics, gut vasoreactivity, diastolic function, blood pressure trajectory, left ventricular hypertrophy) in 210 adolescents (110 obese, 50 sedentary normal-weight, 50 high-activity). Reversibility of this phenotype will be tested in the obese by randomised controlled trial, comparing 8-week supervised exercise to a low-activity sham intervention. This study will provide the platform for developing practical, effective CVD prevention in children that is not simply focused on weight-loss.

Conditions

  • Overweight/Obesity, Adolescent

Interventions

OTHER

Intervention Group

Each participant assigned to this intervention arm will start with a progressive cardiovascular warm-up for 10mins. The main exercise session will consist of resistance and cardiovascular based exercises targeting the whole body, which will last for 35-40mins. A cool-down period will follow lasting 5-10mins.

OTHER

Sham-Exercise Group

Each participant assigned to this intervention arm will start with a warm-up for 10mins, which will be controlled in order to reduce any cardiovascular training effects. The sham-exercise sessions will consist of stretching, coordination and balance activities and very low-level cardiovascular activities that mimic the types of exercise done in the intervention group. This will last for 35-40mins, followed by a 5-10min cool-down.

Sponsors & Collaborators

  • Oxford Brookes University

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Alexander Jones, BM, BSc, FRCP, PhD · University of Oxford

  • Helen Dawes, PhD · Oxford Brookes University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2023-07-31
Completion
2024-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04118543 on ClinicalTrials.gov