Effects of the ActiveBrains trial on cardiometabolic and mental health in children with overweight or obesity: A Randomized Clinical Trial

Abstract

Importance Childhood obesity is a risk factor for type 2 diabetes (T2D), cardiovascular disease, and mental disorders later in life. To investigate the parallel effects on cardiometabolic and mental health in children with overweight or obesity will provide new insights on the benefits of exercise on overall health.

Objective This study aimed to investigate the effects of a 20-week exercise program on cardiometabolic and mental health in children with overweight or obesity.

Design Parallel-group randomized clinical trial (RCT) conducted in Granada (Spain) from November 2014 to June 2016.

Setting Clinical setting.

Participants Eligibility criteria included children with overweight or obesity aged 8 to 11.9 years from Granada (Spain) and surrounding areas.

Intervention The exercise program included 3-5 sessions/week (90 min/session) of aerobic plus resistance training for 20-weeks. The wait-list control group continued with their usual routines.

Main Outcomes and Measures Cardiometabolic outcomes included body composition (fat mass, fat-free mass, and visceral adipose tissue), physical fitness (cardiorespiratory, speed-agility, and muscular), and traditional risk factors (waist circumference, blood lipids biomarkers, glucose, insulin, and blood pressure). Cardiometabolic risk score (z-score) was calculated based on age and sex reference values for triglycerides, inverted high-density lipoprotein cholesterol, glucose, the average of systolic and diastolic blood pressure, and waist circumference. An additional cardiometabolic risk score also included cardiorespiratory fitness. Mental health outcomes included an array of psychological well-being and ill-being indicators.

Results The ActiveBrains exercise program reduced the cardiometabolic risk score by ∼0.4 (95% confidence interval [CI95%]: −0.75, −0.03) standard deviations (SD). The exercise program had a positive effect on low-density lipoprotein cholesterol (−7.40 [CI95%: −14.82, 0.016] mg/dL), body mass index (−0.60 [CI95%: −1.07, −0.13] kg/m2), fat mass index (−0.70 [CI95%: −1.03 to −0.36] kg/m2), visceral adipose tissue (−34.05 [CI95%: −61.38, −6.73] g), and cardiorespiratory fitness (+3.07 [CI95%: 0.68, 5.45] laps) in the exercise group compared to controls. No effects were observed on mental health outcomes.

Conclusions and Relevance The ActiveBrains exercise program improved cardiometabolic health in children with overweight or obesity, yet it had no effect on mental health. These findings support public health initiatives promoting exercise programs in children with excess body weight to prevent future cardiovascular comorbidities.

Question What are the parallel effects of exercise on cardiometabolic and mental health in children with excess of adiposity?

Findings In this parallel-group randomized clinical trial of 109 children with overweight or obesity, a 20-week exercise program including aerobic plus resistance training improved body composition, cardiorespiratory fitness, and cardiometabolic risk factors. No effects on mental health were observed.

Meaning Exercise programs should be promoted in children with excess adiposity to improve their cardiometabolic health.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT02295072

Funding Statement

This project was funded by the Spanish Ministry of Economy and Competitiveness and the Fondo Europeo de Desarrollo Regional (FEDER) (DEP2013 47540, DEP2016 79512R DEP2017 91544-EXP, and RYC 2011 09011). Additional funding was obtained from the Andalusian Operational Programme supported with ERDF (FEDER in Spanish, B CTS 355 UGR18). C.C.S. is supported by a grant from the Spanish Ministry of Science and Innovation (FJC2018 037925-I). J.H.M. is supported by the Spanish Ministry of Education, Culture and Sport (FPU15/02645) and the Swedish Research Council for Health, Working Life and Welfare (2012 00036). L.V.T.L. is supported by a Grant from the Spanish Ministry of Science, Innovation and Universities (FPU17/04802). MRA was funded by the Ramon Areces Foundation (DEP2017 91544-EXP). Additional support was obtained from the Alicia Koplowitz Foundation (ALICIAK-2018), University of Granada, Plan Propio de Investigacion 2016, Excellence actions: Units of Excellence, Unit of Excellence on Exercise and Health (UCEES), the Junta de Andalucia, Consejeria de Conocimiento, Investigacion y Universidades; and under the umbrella of the European Unions Horizon 2020 research and innovation programme under grant agreement No 667302; the EXERNET Research Network on Exercise and Health in Special Populations (DEP2005-00046/ACTI), and the HL-PIVOT network - Healthy Living for Pandemic Event Protection.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The ActiveBrains RCT was approved by the Human Research Ethics Committee of the University of Granada.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

We did not obtain children parents consent to widely share the data nor was it included in the IRB protocol.

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