Evidence map›Paper›PMID 37024918›Full record

ArticleTrials2023

The Canadian Healthy Life Trajectories Initiative (HeLTI) Trial: a study protocol for monitoring fidelity of a preconception-lifestyle behaviour intervention.

Cindy-Lee Dennis, Flavia Marini, Alessandra Prioreschi, Justine Dol, Catherine Birken, Rhonda C Bell

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
3.5field-weighted citation impact, top 8% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. 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

6 authors at 4 institutions in 3 countries.

Cindy-Lee DennisLawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Toronto, ON, M5T 1P8, Canada. cindylee.dennis@utoronto.ca.ORCID http://orcid.org/0000-0002-0135-7242
Flavia MariniLi Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada.
Alessandra PrioreschiSAMRC Developmental Pathways for Health Research Unit, Department of Paediatrics, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa.
Justine DolLi Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada.
Catherine BirkenFaculty of Medicine, University of Toronto, Toronto, Canada.
Rhonda C BellDepartment of Agricultural, Food and Nutritional Sciences, University of Alberta, Edmonton, Canada.
St. Michael's Hospital · CASouth African Medical Research Council · ZAUniversity of Alberta · CAUniversity of Toronto · CA

Funding

CIHR HLC154502
6 · The paper itself

Abstract

backgroundIn evaluating technology-based behaviour change interventions, it is increasingly important to have a monitoring plan for intervention fidelity. It is important to maintain intervention fidelity to ensure that the theory-based intervention that is being tested is what causes the observed changes, particularly for eHealth behaviour change interventions. In this protocol, we outline the intervention fidelity and monitoring protocol for Healthy Life Trajectory Initiative (HeLTI) Canada, a randomized controlled trial evaluating the effect of a preconception-early childhood technology-based intervention delivered by public health nurses among pregnancy-planning women and their partners to optimize child growth and development.

methodsThe HeLTI Canada fidelity protocol is based on the National Institutes of Health Behaviour Change Consortium (NIH BCC) Treatment Fidelity Framework, outlining the following components of intervention fidelity: study design, provider training, intervention delivery, intervention receipt, and intervention enactment. The intervention fidelity components and associated monitoring strategies were developed to align with the HeLTI Canada approach. Strategies for intervention fidelity monitoring include a pre-post written evaluation of training, standardization of provider training, use and monitoring of activity logs, and intervention session checklists. Possible challenges to intervention fidelity include provider turnover due to the length of the trial and lack of ability to directly monitor participant behaviour change in real-life settings. Details about intervention fidelity monitoring are provided in detail. The study launched in January 2021 and is currently recruiting. DISCUSSION: Using the NIH BCC Treatment Fidelity Framework, HeLTI Canada has a robust framework for monitoring and reporting intervention fidelity to improve intervention validity, ability to assess intervention effectiveness, and transparency.

trial registrationISRCN ISRCTN13308752 . Registered on February 29, 2019.

Indexed as

Health StatusLife StyleBehavior TherapyCanadaChildChild, PreschoolFemaleHumansRandomized Controlled Trials as TopicResearch DesigneHealthFidelityInterventionPreventative medicinePublic healthRandomized controlled trial

Identifiers

PMID37024918
PMCPMC10079485
OpenAlexW4362660767

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.