Fast track to health - Intermittent energy restriction in adolescents with obesity. A randomised controlled trial study protocol
| Autor: | Kaitlin Day, Justin C. Brown, Louise A. Baur, Sarah P. Garnett, Krista A. Varady, Susan J. Paxton, Sarah Lang, Kerryn Chisholm, Natalie B. Lister, Megan L. Gow, Alicia Grunseit, Hiba Jebeile, Christopher T. Cowell, Helen Truby, Mary-Kate Inkster, Katharine Aldwell, Shirley Alexander, Clare E. Collins |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Male medicine.medical_specialty Pediatric Obesity Adolescent Diet Reducing Endocrinology Diabetes and Metabolism 030209 endocrinology & metabolism law.invention Body Mass Index 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Weight loss law Weight management Weight Loss Medicine Humans Mass index Medical nutrition therapy Prospective Studies Caloric Restriction Randomized Controlled Trials as Topic 030109 nutrition & dietetics Nutrition and Dietetics business.industry Feeding Behavior medicine.disease Obesity Clinical trial Treatment Outcome Physical therapy Body Composition Female medicine.symptom Fast track business Energy Intake |
| Zdroj: | Obesity researchclinical practice. 14(1) |
| ISSN: | 1871-403X |
| Popis: | 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 (∼800 kcal/3350 kJ/day), then transition to their allocated intervention: IER or CER. IER involves three energy-restricted days/week, consuming one-third of daily energy requirements (∼600−700 kcal/2500−2950 kJ/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 (13–14 years, 1430−1670 kcal/6000−7000 kJ/day; 15–17 years, 1670−1900 kcal/7000−8000 kJ/day). The study will recruit 186 (93 per arm) treatment-seeking adolescents aged 13–17 years 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect