Motivational to Weight Loss version 1 (MWL v.1): Protocol for a feasibility single-arm, open-label clinical trial of a motivational interviewing, stages and processes of change-based intervention for weight loss in adults
Abstract
Introduction: This pilot study will determine the recruitment feasibility, retention, and adhesion for a motivational interviewing program for weight loss. Materials and Methods: The single-arm pilot study will be a feasibility study of the Motivation to Lose Weight version 1 (MLW v.1). The study includes presential and online sessions. Participants will be recruited through advertisements on social media and selected according to the inclusion criteria. Participants will receive 8 sessions of approximately 30-45 minutes of motivational interviewing (MI) according to the processes of change in weight loss, as measured by the S-Weight scale. The results will be evaluated at the beginning and the end of the program, which will last 8 weeks. The primary outcome of the study is feasibility. The intervention will be feasible if adherence to the proposed activities in the sessions is greater than 70%, we can recruit 10 patients within 8 weeks, the proportion of interested people and registered participants is greater than 30%, and more than 75% of participants attend the final study visit. The secondary outcome is weight loss, fat mass percentage, muscle mass, waist and hip measurements, and the scores of behavioral scales. Ethics and discussion: This intervention aims to increase the participant's confidence level to implement actions that lead to the progression of behavior and, consequently, the action and maintenance of the lost weight. This study was approved by the Research Ethics Committee (REC) of the Hospital de Clínicas de Porto Alegre (HCPA) under number 20220209 CAAE 59573622300005327.
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