Evidence map›Paper›PMID 38692428›Full record

ArticleContemporary clinical trials2024

BREATHE-T1D: Using iterative mixed methods to adapt a mindfulness-based intervention for adolescents with type 1 diabetes: Design and development.

Francesca Lupini, Molly Basch, Frances Cooke, Jack Vagadori, Ana Gutierrez-Colina, Katherine Patterson Kelly, Randi Streisand, Lauren Shomaker, Eleanor R Mackey

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05268393 (Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT05268393 nacompletednot on this map

Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1

TypeinterventionalSponsorChildren's National Research InstituteRan2022 to 2023Enrolled42Conditionstype1diabetesArmsBREATHE-T1D
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
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.

Francesca LupiniChildren's National Hospital, 111 Michigan Avenue, Washington, DC 20010, United States of America. Electronic address: flupini@email.sc.edu.
Molly BaschChildren's National Hospital, 111 Michigan Avenue, Washington, DC 20010, United States of America; The George Washington University School of Medicine, Washington, DC, United States of America.
Frances CookeChildren's National Hospital, 111 Michigan Avenue, Washington, DC 20010, United States of America. Electronic address: fcooke@childrensnational.org.
Jack VagadoriChildren's National Hospital, 111 Michigan Avenue, Washington, DC 20010, United States of America. Electronic address: jvagadori@childrensnational.org.
Ana Gutierrez-ColinaColorado State University, Fort Collins, CO, United States of America; University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America. Electronic address: ana.gutierrez_colina@colostate.edu.
Katherine Patterson KellyChildren's National Hospital, 111 Michigan Avenue, Washington, DC 20010, United States of America; The George Washington University School of Medicine, Washington, DC, United States of America. Electronic address: kakelly@childrensnational.org.
Randi StreisandChildren's National Hospital, 111 Michigan Avenue, Washington, DC 20010, United States of America; The George Washington University School of Medicine, Washington, DC, United States of America. Electronic address: rstreis@childrensnational.org.
Lauren ShomakerColorado State University, Fort Collins, CO, United States of America; University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Children's Hospital Colorado, Aurora, CO, United States of America. Electronic address: lauren.shomaker@colostate.edu.
Eleanor R MackeyChildren's National Hospital, 111 Michigan Avenue, Washington, DC 20010, United States of America; The George Washington University School of Medicine, Washington, DC, United States of America. Electronic address: emackey@childrensnational.org.

Funding

PILOT STUDY--SUBSTRATE METABOLISM IN EXTREMELY LOW BIRTH WEIGHT INFANTSP30DK048520 · NIDDK · UNIVERSITY OF COLORADO DENVER · PI Edward L Melanson · 1995 to 2026
$32.6M
Feasibility Trial of a Mindfulness Based Intervention to Reduce Maladaptive Eating Behaviors in Youth with Type 1 DiabetesR34AT011035 · NCCIH · CHILDREN'S RESEARCH INSTITUTE · PI MACKEY, ELEANOR RACE · 2021 to 2022
$757k
NCCIH NIH HHS R34 AT011035
6 · The paper itself

Abstract

backgroundNegative affect is prevalent among adolescents with type 1 diabetes (T1D) and may impact diabetes self-management and outcomes through stress-related behaviors such as disordered eating.

methodsWe describe the development of and design for the adaptation of a mindfulness-based intervention (MBI) for adolescents with T1D and negative affect. BREATHE-T1D is an MBI designed to target negative affect that has been tailored to address the unique lived experiences of adolescents with T1D. Qualitative interviews with stakeholders and participants were used to inform iterative adaptations to the intervention and control curricula over the course of the study. The primary aim of this paper is to describe the design, development, and protocol of the present pilot feasibility trial.

conclusionsIterative, qualitative methodology throughout the adaptation of an intervention is important for ensuring the resulting intervention is relevant and meaningful for the target population. CLINICAL TRIAL REGISTRATION NUMBER: NCT05268393.

Indexed as

Diabetes Mellitus, Type 1MindfulnessAdolescentFeasibility StudiesFemaleHumansMalePilot ProjectsQualitative ResearchResearch DesignSelf-ManagementStress, PsychologicalIntervention adaptationIterative designProgram developmentQualitative researchType 1 diabetes

Identifiers

PMID38692428
PMCPMC11180588

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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.