A pilot and feasibility study of a randomized clinical trial testing a self-compassion intervention aimed to increase physical activity behaviour among people with prediabetes.
Acceptability
Behaviour change
Common humanity
Mindfulness
Self-kindness
Self-regulation
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
27 May 2022
27 May 2022
Historique:
received:
22
09
2021
accepted:
17
05
2022
entrez:
27
5
2022
pubmed:
28
5
2022
medline:
28
5
2022
Statut:
epublish
Résumé
Seventy-five per cent of individuals with prediabetes will eventually be diagnosed with type 2 diabetes. Physical activity is a cornerstone in reducing type 2 diabetes risk but can be a challenging behaviour to adopt for those living with prediabetes. Individuals with prediabetes experience difficult emotions associated with being at risk for a chronic disease, which can undermine self-regulation. Self-compassion enhances self-regulation because it mitigates difficult emotions and promotes adaptive coping. We performed a pilot randomized controlled trial to determine the feasibility and acceptability of a self-compassion informed intervention to increase physical activity for persons with prediabetes. This explanatory mixed methods study tested the feasibility and acceptability of a two-arm, randomized, single-blind, actively controlled, 6-week online intervention. Using a 1:1 allocation ratio, participants (identified as people with prediabetes, low physical activity, and low self-compassion) were randomized to a self-compassion (M Eighteen participants were screened and randomized to one of two conditions. Retention, instructor fidelity, safety, capacity, adherence to most of the study aspects, and acceptability by participants and facilitators all met the criteria for feasibility. Recruitment rate, process time, and adherence to home practice were below our criteria, and we offer ways to address these shortcomings for the efficacy trial. The results from this study suggest that it should be feasible to deliver our intervention while highlighting the alterations to components that may be altered when delivering the efficacy trial. We outline our changes which should improve and enhance the feasibility and acceptability of our planned intervention. Funding for this study was from the Canadian Institutes of Health Research (CIHR). ClinicalTrials.gov, NCT04402710 . Registered on 09 April 2020.
Sections du résumé
BACKGROUND
BACKGROUND
Seventy-five per cent of individuals with prediabetes will eventually be diagnosed with type 2 diabetes. Physical activity is a cornerstone in reducing type 2 diabetes risk but can be a challenging behaviour to adopt for those living with prediabetes. Individuals with prediabetes experience difficult emotions associated with being at risk for a chronic disease, which can undermine self-regulation. Self-compassion enhances self-regulation because it mitigates difficult emotions and promotes adaptive coping. We performed a pilot randomized controlled trial to determine the feasibility and acceptability of a self-compassion informed intervention to increase physical activity for persons with prediabetes.
METHODS
METHODS
This explanatory mixed methods study tested the feasibility and acceptability of a two-arm, randomized, single-blind, actively controlled, 6-week online intervention. Using a 1:1 allocation ratio, participants (identified as people with prediabetes, low physical activity, and low self-compassion) were randomized to a self-compassion (M
RESULTS
RESULTS
Eighteen participants were screened and randomized to one of two conditions. Retention, instructor fidelity, safety, capacity, adherence to most of the study aspects, and acceptability by participants and facilitators all met the criteria for feasibility. Recruitment rate, process time, and adherence to home practice were below our criteria, and we offer ways to address these shortcomings for the efficacy trial.
CONCLUSION
CONCLUSIONS
The results from this study suggest that it should be feasible to deliver our intervention while highlighting the alterations to components that may be altered when delivering the efficacy trial. We outline our changes which should improve and enhance the feasibility and acceptability of our planned intervention. Funding for this study was from the Canadian Institutes of Health Research (CIHR).
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov, NCT04402710 . Registered on 09 April 2020.
Identifiants
pubmed: 35624519
doi: 10.1186/s40814-022-01072-6
pii: 10.1186/s40814-022-01072-6
pmc: PMC9135984
doi:
Banques de données
ClinicalTrials.gov
['NCT04402710']
Types de publication
Journal Article
Langues
eng
Pagination
111Subventions
Organisme : CIHR
ID : 421505
Pays : Canada
Informations de copyright
© 2022. The Author(s).
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