Evidence map›Paper›PMID 25424501›Full record

Trial reportDiabetic medicine : a journal of the British Diabetic Association2015

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, M Seid, J Crandell, L Dolan, W H Lagarde, L Letourneau, D M Maahs, S Marcovina, J Nachreiner, D Standiford and 2 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetic medicine : a journal of the British Diabetic Association, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01286350 (FL3X), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 30% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01286350 nacompletednot on this map

FL3X: An Adaptive Intervention to Improve Outcomes for Youth With Type 1 Diabetes

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2014 to 2018Enrolled258ConditionsType 1 DiabetesArmsFL3X: Flexible Lifestyle Empowering Change
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Comparison of self-care in non-cardiac diabetic patients.Diabetes, metabolic syndrome and obesity : targets and therapy · 2019
    Article
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 1 country.

E J Mayer-DavisDepartment of Nutrition and Department of Medicine, University of North Carolina Chapel Hill, Chapel Hill, NC, USA.
M SeidDivision of Pulmonary Medicine and Anderson Center for Health Systems Excellence, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
J CrandellSchool of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
L DolanDivision of Pediatric Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
W H LagardeChildren's Endocrinology and Diabetes, WakeMed Children's Hospital, Raleigh, NC, USA.
L LetourneauDepartment of Nutrition, University of North Carolina Chapel Hill, Chapel Hill, NC, USA.
D M MaahsBarbara Davis Center for Diabetes, University of Colorado School of Medicine, Aurora, CO, USA.
S MarcovinaNorthwest Lipid Metabolism and Diabetes Research Laboratories, University of Washington, Seattle, WA, USA.
J NachreinerDepartment of Nutrition, University of North Carolina Chapel Hill, Chapel Hill, NC, USA.
D StandifordDivision of Pediatric Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
J ThomasDepartment of Nutrition, University of North Carolina Chapel Hill, Chapel Hill, NC, USA.
T WysockiDepartment of Research, Nemours Children's Clinic, Jacksonville, FL, USA.
University of North Carolina at Chapel Hill · USCincinnati Children's Hospital Medical Center · USNemours Children’s Clinic · USUniversity of Colorado Denver · USUniversity of Washington · USWakeMed · US

Funding

DMHEALTH: FEASIBILITY OF A CELL-PHONE ADHERENCE TRIAL FOR UNDERSERVED T1DM YOUTHR21DK085483 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MAYER-DAVIS, ELIZABETH J, SEID, MICHAEL · 2010 to 2011
$434k
NIDDK NIH HHS R21 DK085483NIDDK NIH HHS R21-DK085483
6 · The paper itself

Abstract

aimTo 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.

methodsParticipants [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.

resultsStudy 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.

conclusionsThe 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).

Indexed as

Life StyleQuality of LifeAdolescentAdolescent BehaviorBehavior TherapyBlood GlucoseChildDiabetes Mellitus, Type 1Feasibility StudiesFemaleGlycated HemoglobinHumansMalePilot ProjectsRisk FactorsStandard of CareBlood GlucoseGlycated Hemoglobin

Identifiers

PMID25424501
PMCPMC4437823
OpenAlexW1967873350

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.