Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 16, 2022
Date Accepted: Aug 29, 2022
Acceptability and feasibility of the TELEhealth BARIatric behavioural intervention to increase physical ACTIVity (TELE-BariACTIV): A single-case experimental study protocol
ABSTRACT
Background:
Regular physical activity (PA) is recommended to optimize metabolic and bariatric surgery (MBS) weight and health outcomes. However, more than 70% of patients have low PA levels before MBS that persist after MBS. Whilst behavioural interventions delivered face-to-face have shown promise for increasing PA among MBS patients, many patients may experience barriers, preventing enrollment into and/or adherence to such interventions. Delivering PA behaviour change interventions via telehealth to MBS patients may be an effective strategy to overcome these barriers to increase accessibility and reach, as well as adherence.
Objective:
The first objective of the study is to assess the feasibility and acceptability of the protocol and the TELEhealth BARIatric behavioural-intervention (TELE-BariACTIV) – an intervention designed to increase moderate-to-vigorous intensity PA (MVPA) in patients awaiting bariatric surgery that is guided by two perspectives: 1) a multitheory approach; and 2) a patient perspective. The second objective is to generate estimate of the effect of the TELE-BariACTIV intervention on pre-surgical MVPA (primary outcome for a future randomized controlled trial (RCT)) to inform appropriate sample size for a multicenter RCT.
Methods:
A multicenter study will be conducted with a repeated (ABAB’A) single-case experimental design. The A phases are observational phases without intervention (A1 = pre-MBS; A2 = length personalized according to MBS date; A3 = 7 months post-MBS). The B phases are interventional phases with PA counseling (B1 = 6 weekly pre-MBS sessions; B2 = 3 monthly sessions starting 3 months post-MBS). Twelve inactive adults awaiting sleeve gastrectomy who have access to a computer with internet and an interface with a camera will be recruited. Participants will be randomly allocated to a 1- or 2-week baseline period (A1). Protocol and intervention feasibility and acceptability (primary outcomes) will be assessed by recording missing data, refusal, recruitment, retention, attendance, and attrition rates, as well as via online acceptability questionnaire, and semi-structured individual interviews. Accelerometry (7-14 days) on 8 occasions and questionnaires on 10 occasions will be used to assess MVPA. Generalization measures assessing quality of life, anxiety and depressive symptoms, and theory-based constructs (i.e., motivational regulations for PA, self-efficacy to overcome barriers to PA, basic psychological needs satisfaction and frustration, PA enjoyment, social support for PA; secondary outcomes for a future RCT) will be completed via online questionnaires on 6 to 10 occasions. rolled trial (RCT)) to inform appropriate sample size for a multicenter RCT.
Results:
This study is innovative in its approach and design. If feasibility, acceptability, and preliminary efficacy are demonstrated, the results will inform a future multicentre RCT, which could ultimately increase accessibility and reach of PA behaviour change interventions for many patients who experience barriers to participation.
Conclusions:
The TELE-BariACTIV intervention has potential for implementation across a multitude of settings due to it being offered remotely and its collaborative construction. Clinical Trial: None
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.