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

NCT04118543 | Unknown

• 1 other identifier: R54302/RE001
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Obesity; Cardiometabolic; Adolescence; Exercise

Outcome Measures

Primary Outcomes (4)

• Cardiometabolic phenotype score

  An additive cardiometabolic phenotype score will be defined as the sum of the z-scores of known elements of cardiometabolic risk with each element scored such that a positive value indicates greater risk. The following elements will be scored positively in the risk model: low cardiac phosphocreatine and adenosine triphosphate (PCr/ATP) ratio z-score by phosphate Magnetic Resonance Spectroscopy (MRS), high aortic pulse wave velocity z-score (arterial stiffness) by Magnetic Resonance (MR), high Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) z-score (insulin resistance), high visceral fat mass z-score by T2\*-IDEAL MR, high left ventricular mass z-score by MR, low peak left ventricular diastolic filling rate z-score by MR, and high 24 hour ambulatory blood pressure z-score.

  Changes from baseline - 8 weeks

• Superior mesenteric artery blood flow after a meal challenge

  Assessing the change of blood flow (l/min) in the superior mesenteric artery in response to a meal challenge, measured by phase-contrast MR.

  Changes from baseline - 8 weeks

• Muscle acetylcarnitine

  Increased acetylcarnitine is a marker of skeletal muscle metabolism, measured by MRS.

  Changes from baseline - 8 weeks

• Triglyceride

  Blood plasma (mmol/l) post prandial triglyceride response.

  Changes from baseline - 8 weeks

Secondary Outcomes (28)

• Echocardiography - Diastolic Function

  Changes from baseline - 8 weeks

• High Density Lipoprotein (HDL)

  Changes from baseline - 8 weeks

• Low Density Lipoprotein (LDL)

  Changes from baseline - 8 weeks

• Alanine aminotransferase (ALT)

  Changes from baseline - 8 weeks

• Aspartate Aminotransferase (AST)

  Changes from baseline - 8 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will take part in three 1-hour targeted moderate-to-vigorous physical activity (MVPA) gym-based group exercise sessions per week for eight weeks with individualised prescriptions.

Other: Intervention Group

Sham-Exercise Group

SHAM COMPARATOR

The shame-exercise group will complete three sham exercise group sessions per week for eight weeks (including stretching, coordination and balance activities and very low-level cardiovascular activities that mimic the types of exercise done in the intervention group).

Other: Sham-Exercise Group

Interventions

Intervention Group OTHER

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.

Also known as: Exercise Intervention Group

Intervention Group

Sham-Exercise Group OTHER

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.

Sham-Exercise Group

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants willing and able to register their informed assent and whose parent(s)/guardian(s), give informed consent for participation of their child in the study
• Age and sex-appropriate BMI scores using the World Health Organisation standards for obesity and normal weight
• Objectively measured physical activity

You may not qualify if:

• Contraindications for exercise intervention as determined by the Physical Activity Readiness Questionnaire
• Safety issues due to behavioural/intellectual limitations
• Medical Conditions such as neurological disorders or uncontrolled epilepsy
• Allergies to dairy
• Type 1 diabetes
• Pregnancy
• Contraindications for Magnetic Resonance scans

Sponsors & Collaborators

• University of Oxford: lead
• Oxford Brookes University: collaborator

Study Sites (1)

Oxford Centre for Clinical Magnetic Resonance Research (OCMR)

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Alexander Jones, BM, BSc, FRCP, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Helen Dawes, PhD

  Oxford Brookes University

  STUDY DIRECTOR

Central Study Contacts

Alexander Jones, BM, BSc, FRCP, PhD

CONTACT

07423474923; alexander.jones@paediatrics.ox.ac.uk

Benjamin D Weedon, BSc, MSc, PhD

CONTACT

01865 483272; b.weedon@brookes.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: October 8, 2019
• Study Start: October 1, 2019
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2024
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)