ABSTRACT
BACKGROUND: Regular physical activity (PA) is recommended to optimize weight and health outcomes in patients who have undergone metabolic and bariatric surgery (MBS). However, >70% of patients have low PA levels before MBS that persist after MBS. Although behavioral interventions delivered face-to-face have shown promise for increasing PA among patients who have undergone MBS, many may experience barriers, preventing enrollment into and adherence to such interventions. Delivering PA behavior change interventions via telehealth to patients who have undergone MBS may be an effective strategy to increase accessibility and reach, as well as adherence. OBJECTIVE: This paper reports the protocol for a study that aims to assess the feasibility and acceptability of the protocol or methods and the Telehealth Bariatric Behavioral Intervention (TELE-BariACTIV). The intervention is designed to increase moderate-to-vigorous intensity PA (MVPA) in patients awaiting bariatric surgery and is guided by a multitheory approach and a patient perspective. Another objective is to estimate the effect of the TELE-BariACTIV intervention on presurgical MVPA to determine the appropriate sample size for a multicenter trial. METHODS: This study is a multicenter trial using a repeated (ABAB'A) single-case experimental design. The A phases are observational phases without intervention (A1=pre-MBS phase; A2=length personalized according to the MBS date; A3=7 months post-MBS phase). The B phases are interventional phases with PA counseling (B1=6 weekly pre-MBS sessions; B2=3 monthly sessions starting 3 months after MBS). The target sample size is set to 12. Participants are inactive adults awaiting sleeve gastrectomy who have access to a computer with internet and an interface with a camera. The participants are 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 web-based acceptability questionnaires and semistructured interviews. Data collected via accelerometry (7-14 days) on 8 occasions and via questionnaires on 10 occasions will be analyzed to estimate the effect of the intervention on MVPA. Generalization measures assessing the quality of life, anxiety and depressive symptoms, and theory-based constructs (ie, motivational regulations for PA, self-efficacy to overcome barriers to PA, basic psychological needs satisfaction and frustration, PA enjoyment, and social support for PA; secondary outcomes for a future large-scale trial) will be completed via web-based questionnaires on 6-10 occasions. The institutional review board provided ethics approval for the study in June 2021. RESULTS: Recruitment began in September 2021, and all the participants were enrolled (n=12). Data collection is expected to end in fall 2023, depending on the MBS date of the recruited participants. CONCLUSIONS: The TELE-BariACTIV intervention has the potential for implementation across multiple settings owing to its collaborative construction that can be offered remotely. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39633.
ABSTRACT
This systematic review and meta-analysis assessed the feasibility and acceptability of exercise and controlled trial methods in adults awaiting or having undergone bariatric surgery (BS). Search methods used to identify relevant articles were inclusion of articles identified in a systematic review, new database search of articles published 2019-2021, and hand searching reference lists. Titles/abstracts and full-texts were screened by two reviewers independently against inclusion criteria: adults awaiting or having undergone BS, controlled trial, exercise group compared with a comparison group without exercise. Twenty-eight articles were reviewed; most interventions were supervised, performed after BS, and lasted ≤13 weeks. Pooled data for exercise intervention attendance and dropout rates were 84% (k = 10) and 5% (k = 19), respectively, though possibly misestimated due to poor/selective reporting. Median study and recruitment duration were 18 weeks and 24 months, respectively, with a pooled enrollment rate of 2.5 participants/month. Pooled data for refusal to participate, enrollment, and retention rates were 23% (k = 16), 43% (k = 18), and 87% (k = 26), respectively. Despite the lack of data available in studies included, exercise and controlled trial methods seem feasible and acceptable for adults awaiting or having undergone BS. To better identify methodological or practical challenges, and assess bias, better reporting of feasibility and acceptability indicators is needed in future studies.
