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Randomized Controlled Trial
. 2015 Jun;32(6):829-33.
doi: 10.1111/dme.12641. Epub 2014 Dec 30.

Flexible Lifestyles for Youth (FL3X) behavioural intervention for at-risk adolescents with Type 1 diabetes: a randomized pilot and feasibility trial

E J Mayer-Davis  1 , M Seid  2 , J Crandell  3 , L Dolan  4 , W H Lagarde  5 , L Letourneau  6 , D M Maahs  7 , S Marcovina  8 , J Nachreiner  6 , D Standiford  4 , J Thomas  6 , T Wysocki  9
Affiliations
Randomized Controlled Trial

Flexible Lifestyles for Youth (FL3X) behavioural intervention for at-risk adolescents with Type 1 diabetes: a randomized pilot and feasibility trial

E J Mayer-Davis et al. Diabet Med. 2015 Jun.

Abstract

Aim: 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).

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Figures

FIGURE 1
FIGURE 1
Flexible Lifestyles for Youth (FL3X) pilot and feasibility study: CONSORT flow diagram.
See this image and copyright information in PMC

References

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