Acceptability and feasibility of the TELEhealth BARIatric behavioural intervention to increase physical ACTIVity (TELE-BariACTIV): A single-case experimental study protocol (Preprint)
Authors: Baillot Aurelie , St-Pierre Maxime , Lapointe Josyanne , Bernard Paquito , Bond Dale , Romain Ahmed  Jérôme , Garneau Pierre Yves , Biertho Laurent , Tchernof André , Blackburn Patricia , Langlois Marie France , Brunet Jennifer 
Published: May 2022

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.

CLINICALTRIAL

None