Fast track to health - Intermittent energy restriction in adolescents with obesity. A randomised controlled trial study protocol

Natalie B Lister; Hiba Jebeile; Helen Truby; Sarah P Garnett; Krista A Varady; Christopher T Cowell; Clare E Collins; Susan J Paxton; Megan L Gow; Justin Brown; Shirley Alexander; Kerryn Chisholm; Alicia M Grunseit; Katharine Aldwell; Kaitlin Day; Mary-Kate Inkster; Sarah Lang; Louise A Baur

doi:10.1016/j.orcp.2019.11.005

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. doi: 10.1016/j.orcp.2019.11.005. Epub 2019 Dec 7.

Authors

Natalie B Lister¹, Hiba Jebeile², Helen Truby³, Sarah P Garnett⁴, Krista A Varady⁵, Christopher T Cowell⁴, Clare E Collins⁶, Susan J Paxton⁷, Megan L Gow², Justin Brown⁸, Shirley Alexander⁹, Kerryn Chisholm¹⁰, Alicia M Grunseit¹⁰, Katharine Aldwell¹¹, Kaitlin Day³, Mary-Kate Inkster¹², Sarah Lang³, Louise A Baur¹³

Affiliations

¹ 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.
² 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.
³ Monash University, Nutrition, Dietetics & Food, Melbourne, VIC, Australia.
⁴ 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.
⁵ University of Illinois, Department of Kinesiology and Nutrition, Chicago, USA.
⁶ University of Newcastle, Priority Research Centre in Physical Activity and Nutrition, School of Health Sciences, Faculty of Health and Medicine, Newcastle, NSW 2308, Australia.
⁷ La Trobe University, School of Psychology and Public Health, Melbourne, VIC, Australia.
⁸ Monash University, Department of Paediatrics, Clayton, VIC 3168, Australia; Monash Children's Hospital, Department of Paediatric Endocrinology and Diabetes, Clayton, VIC 3168, Australia.
⁹ The Children's Hospital at Westmead, Weight Management Services, Westmead, NSW 2145, Australia.
¹⁰ 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.
¹¹ The Children's Hospital at Westmead, Institute of Endocrinology and Diabetes, Westmead, NSW 2145, Australia.
¹² Monash University, Nutrition, Dietetics & Food, Melbourne, VIC, Australia; Monash Children's Hospital, Department of Paediatric Endocrinology and Diabetes, Clayton, VIC 3168, Australia.
¹³ 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.

PMID: 31818675
DOI: 10.1016/j.orcp.2019.11.005

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.

Keywords: Diet intervention; Intermittent energy restriction; Obesity; Paediatric; Weight loss.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Body Composition
Body Mass Index
Caloric Restriction* / methods
Diet, Reducing* / methods
Energy Intake* / physiology
Feeding Behavior / physiology
Female
Humans
Male
Multicenter Studies as Topic
Pediatric Obesity* / physiopathology
Pediatric Obesity* / therapy
Prospective Studies
Randomized Controlled Trials as Topic
Treatment Outcome
Weight Loss*

Associated data

ANZCTR/ACTRN12617001630303