title: Flexible Lifestyles for Youth (FL3X) behavioural intervention for at-risk adolescents with Type 1 diabetes: a randomized pilot and feasibility trial.
abstract: OBJECTIVE
  To determine the potential effect sizes for the Flexible Lifestyle for Youth (FL3X) behavioural intervention to improve glycaemic control (HbA(1c)) and quality of life for at-risk adolescents with Type 1 diabetes.
  
  
  METHODS
  Participants [n = 61; age 12-16 years, HbA(1c) 64-119 mmol/mol (8-13%)] were randomized to FL3X (minimum three sessions) or usual care. Effect sizes (Cohen's d), comparing the mean difference between the groups, were calculated.
  
  
  RESULTS
  Study retention (95%), attendance at intervention sessions (87% attended all three sessions) and acceptability were high (100% of the adolescents and 91% of parents would recommend the programme to others). Overall, 41% of participants in the intervention group and 24% of participants in the control group were 'responders' [HbA(1c) decreased by > 6 mmol/mol (0.5%); d = 0.37]. HbA(1c) levels decreased (d = -0.18), diabetes-specific quality of life increased (d = 0.29), but generic quality of life decreased (d = -0.23) in the intervention compared with the control group.
  
  
  CONCLUSIONS
  The FL3X programme merits further study for improving HbA(1c) and diabetes-specific quality of life in adolescents with Type 1 diabetes. (Clinical trials registry no.: NCT01286350).
authors.affiliation: Department of Nutrition and Department of Medicine, University of North Carolina Chapel Hill, Chapel Hill, NC, USA.
authors.forename: E J
authors.initials: EJ
authors.lastname: Mayer-Davis
authors.affiliation: Division of Pulmonary Medicine and Anderson Center for Health Systems Excellence, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors.forename: M
authors.initials: M
authors.lastname: Seid
authors.affiliation: School of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: J
authors.initials: J
authors.lastname: Crandell
authors.affiliation: Division of Pediatric Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors.forename: L
authors.initials: L
authors.lastname: Dolan
authors.affiliation: Children's Endocrinology and Diabetes, WakeMed Children's Hospital, Raleigh, NC, USA.
authors.forename: W H
authors.initials: WH
authors.lastname: Lagarde
authors.affiliation: Department of Nutrition, University of North Carolina Chapel Hill, Chapel Hill, NC, USA.
authors.forename: L
authors.initials: L
authors.lastname: Letourneau
authors.affiliation: Barbara Davis Center for Diabetes, University of Colorado School of Medicine, Aurora, CO, USA.
authors.forename: D M
authors.initials: DM
authors.lastname: Maahs
authors.affiliation: Northwest Lipid Metabolism and Diabetes Research Laboratories, University of Washington, Seattle, WA, USA.
authors.forename: S
authors.initials: S
authors.lastname: Marcovina
authors.affiliation: Department of Nutrition, University of North Carolina Chapel Hill, Chapel Hill, NC, USA.
authors.forename: J
authors.initials: J
authors.lastname: Nachreiner
authors.affiliation: Division of Pediatric Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors.forename: D
authors.initials: D
authors.lastname: Standiford
authors.affiliation: Department of Nutrition, University of North Carolina Chapel Hill, Chapel Hill, NC, USA.
authors.forename: J
authors.initials: J
authors.lastname: Thomas
authors.affiliation: Department of Research, Nemours Children's Clinic, Jacksonville, FL, USA.
authors.forename: T
authors.initials: T
authors.lastname: Wysocki
mesh_terms: D000293:Adolescent; D000294:Adolescent Behavior; D001521:Behavior Therapy / Q000379:methods*; D001786:Blood Glucose / Q000378:metabolism; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000628:therapy*; D005240:Feasibility Studies; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D008019:Life Style; D008297:Male; D010865:Pilot Projects; D011788:Quality of Life; D012307:Risk Factors; D059039:Standard of Care
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin