Evidence map›Paper›PMID 29277316›Full record

ArticleContemporary clinical trials2018

The Flexible Lifestyle Empowering Change (FLEX) intervention for self-management in adolescents with type 1 diabetes: Trial design and baseline characteristics.

Jessica C Kichler, Michael Seid, Jamie Crandell, David M Maahs, Franziska K Bishop, Kimberly A Driscoll, Debra Standiford, Christine M Hunter, Elizabeth Mayer-Davis

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05147324 (Individualized Planned Eating Patterns to Improve Glycemic Management in Adolescents With Type 1 Diabetes), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
–field-weighted citation impact
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.

NCT05147324 nacompletednot on this mapstarted 2021, after this paper: background citation

Individualized Planned Eating Patterns to Improve Glycemic Management in Adolescents With Type 1 Diabetes: A Pilot Clinical Trial

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2021 to 2023Enrolled52ConditionsType 1 DiabetesArms"MyPlan" - Individualized Planned Eating Pattern
3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

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  18. Two-step recruitment process optimizes retention in FLEX clinical trial.Contemporary clinical trials communications · 2018
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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

9 authors.

Jessica C KichlerCincinnati Children's Hospital Medical Center, University of Cincinnati Medical School, United States. Electronic address: Jessica.kichler@cchmc.org.
Michael SeidCincinnati Children's Hospital Medical Center, University of Cincinnati Medical School, United States.
Jamie CrandellDepartment of Nutrition, University of North Carolina, United States.
David M MaahsDepartment of Pediatrics, School of Medicine, Stanford University, United States.
Franziska K BishopBarbara Davis Center for Childhood Diabetes, University of Colorado Denver, United States.
Kimberly A DriscollBarbara Davis Center for Childhood Diabetes, University of Colorado Denver, United States.
Debra StandifordCincinnati Children's Hospital Medical Center, University of Cincinnati Medical School, United States.
Christine M HunterNational Institute of Diabetes and Digestive and Kidney Diseases, United States.
Elizabeth Mayer-DavisDepartment of Nutrition, University of North Carolina, United States.

Funding

UNIV OF NORTH CAROLINA CLINICAL NUTRITION RESEARCH UNITP30DK056350 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Ian Michael Carroll · 1999 to 2026
$31.6M
FL3X: An Adaptive Intervention to Improve Outcomes for Youth with Type 1 DiabetesUC4DK101132 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MAAHS, DAVID MATTHEW, MAYER-DAVIS, ELIZABETH J · 2013 to 2013
$6.9M
NIDDK NIH HHS P30 DK056350NIDDK NIH HHS UC4 DK101132
6 · The paper itself

Abstract

The Flexible Lifestyle Empowering Change (FLEX) Intervention Study is a multi-site randomized controlled trial to test the efficacy of an adaptive behavioral intervention to promote self-management for youth with type 1 diabetes mellitus (T1D). This paper details FLEX design, demographic characteristics of the sample, and outcome variables at baseline. Participants were randomized to either an intervention or control arm after their baseline standardized measurement visit. Baseline data for the primary (glycemic levels) and secondary outcome variables (e.g., motivation and problem-solving, health-related quality of life, risk factors associated with T1D complications) as well as the potential mediator variables (e.g., self-management behavior, family conflict and responsibility) suggest that the study sample was representative of the general population of adolescents with T1D and their parents. The FLEX adaptive intervention is an innovative application of a tailored treatment intervention designed to be readily adopted in real-world practice to meet each adolescent's individualized T1D self-management goals.

Indexed as

Diabetes Mellitus, Type 1Life StyleSelf-ManagementAdaptive Clinical Trials as TopicAdolescentBehavior TherapyBlood GlucoseFamily ConflictGlycated HemoglobinHealth StatusHumansHypoglycemiaHypoglycemic AgentsMotivationMulticenter Studies as TopicParentsBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsAdolescentsHealth interventionsParentsType 1 diabetes

Identifiers

PMID29277316
PMCPMC5828911

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.