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Fast track to health - Intermittent energy restriction in adolescents with obesity. A randomised controlled trial study protocol.
Obes Res Clin Pract. 2020 Jan - Feb; 14(1):80-90.OR

Abstract

BACKGROUND

Intermittent energy restriction (IER) has shown early success in adolescents with obesity, however efficacy trials are needed. This study aims to determine if IER results in lower body mass index (BMI) z-score after 52 weeks in metabolically unhealthy adolescents with obesity compared with continuous energy restriction (CER).

METHODS/DESIGN

This is a prospective, randomised, multi-centre trial conducted in tertiary care settings, with three phases: jumpstart (weeks 0-4); intensive intervention (weeks 5-16); continued intervention and/or maintenance (weeks 17-52). During the jumpstart phase, all participants follow a very low energy diet (∼800kcal/3350kJ/day), then transition to their allocated intervention: IER or CER. IER involves three energy-restricted days/week, consuming one-third of daily energy requirements (∼600-700kcal/2500-2950kJ/day), and four days/week of a healthy meal plan. The CER, which is current standard care, has individually tailored energy prescription based on age and sex (13-14years, 1430-1670kcal/6000-7000kJ/day; 15-17years, 1670-1900kcal/7000-8000kJ/day). The study will recruit 186 (93 per arm) treatment-seeking adolescents aged 13-17years with obesity and at least one metabolic co-morbidity. The primary outcome is change in BMI z-score at 52 weeks. Secondary outcomes are changes at 4, 16 and 52 weeks in: body composition; diet quality, food choices and food patterns; cardio-metabolic risk factors; physical activity and sedentary behaviour; sleep and psycho-behavioural measures.

DISCUSSION

This study challenges existing clinical paradigms that CER is the only method for weight management in metabolically unhealthy adolescents. If successful, IER may offer an alternate medical nutrition therapy approach for those seeking treatment in tertiary settings.

CLINICAL TRIAL REGISTRATION NUMBER

ACTRN12617001630303.

Authors+Show Affiliations

The University of Sydney, Sydney Medical School, Discipline of Child and Adolescent Health, Westmead, NSW 2145, Australia; The Children's Hospital at Westmead, Institute of Endocrinology and Diabetes, Westmead, NSW 2145, Australia. Electronic address: natalie.lister@health.nsw.gov.au.The University of Sydney, Sydney Medical School, Discipline of Child and Adolescent Health, Westmead, NSW 2145, Australia; The Children's Hospital at Westmead, Institute of Endocrinology and Diabetes, Westmead, NSW 2145, Australia.Monash University, Nutrition, Dietetics & Food, Melbourne, VIC, Australia.The University of Sydney, Sydney Medical School, Discipline of Child and Adolescent Health, Westmead, NSW 2145, Australia; The Children's Hospital at Westmead, Institute of Endocrinology and Diabetes, Westmead, NSW 2145, Australia; Kids Research, The Children's Hospital at Westmead, Westmead, NSW 2145, Australia.University of Illinois, Department of Kinesiology and Nutrition, Chicago, USA.The University of Sydney, Sydney Medical School, Discipline of Child and Adolescent Health, Westmead, NSW 2145, Australia; The Children's Hospital at Westmead, Institute of Endocrinology and Diabetes, Westmead, NSW 2145, Australia; Kids Research, The Children's Hospital at Westmead, Westmead, NSW 2145, Australia.University of Newcastle, Priority Research Centre in Physical Activity and Nutrition, School of Health Sciences, Faculty of Health and Medicine, Newcastle, NSW 2308, Australia.La Trobe University, School of Psychology and Public Health, Melbourne, VIC, Australia.The University of Sydney, Sydney Medical School, Discipline of Child and Adolescent Health, Westmead, NSW 2145, Australia; The Children's Hospital at Westmead, Institute of Endocrinology and Diabetes, Westmead, NSW 2145, Australia.Monash University, Department of Paediatrics, Clayton, VIC 3168, Australia; Monash Children's Hospital, Department of Paediatric Endocrinology and Diabetes, Clayton, VIC 3168, Australia.The Children's Hospital at Westmead, Weight Management Services, Westmead, NSW 2145, Australia.The Children's Hospital at Westmead, Weight Management Services, Westmead, NSW 2145, Australia; The Children's Hospital at Westmead, Nutrition and Dietetics, Westmead, NSW 2145, Australia.The Children's Hospital at Westmead, Weight Management Services, Westmead, NSW 2145, Australia; The Children's Hospital at Westmead, Nutrition and Dietetics, Westmead, NSW 2145, Australia.The Children's Hospital at Westmead, Institute of Endocrinology and Diabetes, Westmead, NSW 2145, Australia.Monash University, Nutrition, Dietetics & Food, Melbourne, VIC, Australia.Monash University, Nutrition, Dietetics & Food, Melbourne, VIC, Australia; Monash Children's Hospital, Department of Paediatric Endocrinology and Diabetes, Clayton, VIC 3168, Australia.Monash University, Nutrition, Dietetics & Food, Melbourne, VIC, Australia.The University of Sydney, Sydney Medical School, Discipline of Child and Adolescent Health, Westmead, NSW 2145, Australia; The Children's Hospital at Westmead, Weight Management Services, Westmead, NSW 2145, Australia.

Pub Type(s)

Clinical Trial Protocol
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31818675

Citation

Lister, Natalie B., et al. "Fast Track to Health - Intermittent Energy Restriction in Adolescents With Obesity. a Randomised Controlled Trial Study Protocol." Obesity Research & Clinical Practice, vol. 14, no. 1, 2020, pp. 80-90.
Lister NB, Jebeile H, Truby H, et al. Fast track to health - Intermittent energy restriction in adolescents with obesity. A randomised controlled trial study protocol. Obes Res Clin Pract. 2020;14(1):80-90.
Lister, N. B., Jebeile, H., Truby, H., Garnett, S. P., Varady, K. A., Cowell, C. T., Collins, C. E., Paxton, S. J., Gow, M. L., Brown, J., Alexander, S., Chisholm, K., Grunseit, A. M., Aldwell, K., Day, K., Inkster, M. K., Lang, S., & Baur, L. A. (2020). Fast track to health - Intermittent energy restriction in adolescents with obesity. A randomised controlled trial study protocol. Obesity Research & Clinical Practice, 14(1), 80-90. https://doi.org/10.1016/j.orcp.2019.11.005
Lister NB, et al. Fast Track to Health - Intermittent Energy Restriction in Adolescents With Obesity. a Randomised Controlled Trial Study Protocol. Obes Res Clin Pract. 2020 Jan - Feb;14(1):80-90. PubMed PMID: 31818675.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Fast track to health - Intermittent energy restriction in adolescents with obesity. A randomised controlled trial study protocol. AU - Lister,Natalie B, AU - Jebeile,Hiba, AU - Truby,Helen, AU - Garnett,Sarah P, AU - Varady,Krista A, AU - Cowell,Christopher T, AU - Collins,Clare E, AU - Paxton,Susan J, AU - Gow,Megan L, AU - Brown,Justin, AU - Alexander,Shirley, AU - Chisholm,Kerryn, AU - Grunseit,Alicia M, AU - Aldwell,Katharine, AU - Day,Kaitlin, AU - Inkster,Mary-Kate, AU - Lang,Sarah, AU - Baur,Louise A, Y1 - 2019/12/07/ PY - 2019/06/28/received PY - 2019/11/20/revised PY - 2019/11/20/accepted PY - 2019/12/11/pubmed PY - 2021/1/23/medline PY - 2019/12/11/entrez KW - Diet intervention KW - Intermittent energy restriction KW - Obesity KW - Paediatric KW - Weight loss SP - 80 EP - 90 JF - Obesity research & clinical practice JO - Obes Res Clin Pract VL - 14 IS - 1 N2 - BACKGROUND: Intermittent energy restriction (IER) has shown early success in adolescents with obesity, however efficacy trials are needed. This study aims to determine if IER results in lower body mass index (BMI) z-score after 52 weeks in metabolically unhealthy adolescents with obesity compared with continuous energy restriction (CER). METHODS/DESIGN: This is a prospective, randomised, multi-centre trial conducted in tertiary care settings, with three phases: jumpstart (weeks 0-4); intensive intervention (weeks 5-16); continued intervention and/or maintenance (weeks 17-52). During the jumpstart phase, all participants follow a very low energy diet (∼800kcal/3350kJ/day), then transition to their allocated intervention: IER or CER. IER involves three energy-restricted days/week, consuming one-third of daily energy requirements (∼600-700kcal/2500-2950kJ/day), and four days/week of a healthy meal plan. The CER, which is current standard care, has individually tailored energy prescription based on age and sex (13-14years, 1430-1670kcal/6000-7000kJ/day; 15-17years, 1670-1900kcal/7000-8000kJ/day). The study will recruit 186 (93 per arm) treatment-seeking adolescents aged 13-17years with obesity and at least one metabolic co-morbidity. The primary outcome is change in BMI z-score at 52 weeks. Secondary outcomes are changes at 4, 16 and 52 weeks in: body composition; diet quality, food choices and food patterns; cardio-metabolic risk factors; physical activity and sedentary behaviour; sleep and psycho-behavioural measures. DISCUSSION: This study challenges existing clinical paradigms that CER is the only method for weight management in metabolically unhealthy adolescents. If successful, IER may offer an alternate medical nutrition therapy approach for those seeking treatment in tertiary settings. CLINICAL TRIAL REGISTRATION NUMBER: ACTRN12617001630303. SN - 1871-403X UR - https://www.unboundmedicine.com/medline/citation/31818675/Fast_track_to_health___Intermittent_energy_restriction_in_adolescents_with_obesity__A_randomised_controlled_trial_study_protocol_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1871-403X(19)30375-8 DB - PRIME DP - Unbound Medicine ER -