Targeting Sedentary Behavior Reduction and Physical Fitness Enhancement in Women Before and Beyond Bariatric Surgery- BARIMOV Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
研究概览
简要总结
Introduction: Sedentary behavior (SB) and insufficient physical activity (PA) interact to worsen physical fitness (PF), obesity-related complications and diseases (ORCD), and all-cause mortality in women with obesity. Replacing SB with low-intensity PA may improve PF and ameliorate ORCD, with potential lasting effects after bariatric surgery (BS). However, strong evidence on how PF influences BS outcomes and whether preoperative PA interventions can improve postoperative outcomes is lacking. The BARIMOV study aims to evaluate the effects of a structured sedentary behavior reduction program (SBRPro) on PF, investigate whether PF improvements influence BS outcomes, and explore potential mechanistic pathways by characterizing molecular adaptations in peripheral blood, skeletal muscle, and visceral adipose tissue (VAT).
Methods: BARIMOV is a prospective cohort study with five assessment time points. Adult women (≥18 years) with BMI 30-45 kg/m² scheduled for BS will be recruited (n = 72). At T0, participants will undergo a baseline assessment of PF - body composition, muscle strength, cardiorespiratory fitness - PA patterns, and ORCD screening. Participants will be instructed in the SBRPro and asked to maintain weekly PA diaries throughout the pre- and post-operative periods. At T1, adherence to SBRPro will be evaluated via diary review and PF reassessment, to enable participants' allocation into two adherence-based groups. At T2, during surgery, skeletal muscle and VAT biopsies will be collected for proteomic analysis to compare molecular adaptations of adherent and non-adherent groups. At T3 and T4, primary outcomes, including weight loss, body composition, ORCD, and quality of life (QoL), will be evaluated at 3±1 and 12±1 months postoperatively, respectively. Blood multiomics profiling will be performed at T0, T1, and T3 to explore dynamic changes in systemic metabolic pathways over time.
Conclusion: This study will determine whether PF improvement, achieved through structured SB reduction and PA engagement, is associated with better BS outcomes. By integrating clinical and molecular endpoints, the study will provide mechanistic insights into the pathways by which PF enhances BS outcomes and inform physical activity intervention strategies.
详细描述
- Study Design and Participants BARIMOV will be a prospective cohort study designed to evaluate the effects of an SBRPro on BS outcomes in women and to explore the biological mechanisms underlying these effects. The study includes five predefined assessment timepoints: baseline (T0, 6±3 months before surgery), preoperative reassessment (T1, 2 weeks±3 days before surgery), intraoperative biopsies (T2), early postoperative reassessment (T3, 3±1 months after surgery), and final postoperative reassessment (T4, 12±2 months after surgery).
- Intervention Participants will be instructed to follow an online SBRPro program initiated 6±3 months before surgery. SBRPro provides standardized guidance on decreasing sedentary time and increasing regular PA, tailored to individual capabilities, delivered via mobile phone apps featuring messages, videos, and PA and exercise tutorials. The intervention will comprise 3 main phases.
Phase 1: Enrollment and Multidisciplinary Education (T0) All participants will attend a group educational session (40 minutes) delivered by a multidisciplinary team (bariatric surgeon, exercise physiologist, dietitian) addressing: 1) overall education about the BS clinical process and surgery procedures, risks, advantages and disadvantages; 2) a comprehensive education on SB harms and health risks, and benefits of PA across the pre- and post-operative period; 3) practical strategies for reducing sedentary time (e.g., breaking up prolonged sitting or interrupting extended bouts); 4) PA safety, proper exercise execution, PA intensity management and progression strategies; 5) nutritional education for preoperative fitness and postoperative recovery; and 6) distribution of written materials (flyers and booklets) summarizing key take home contents delivered at the session.
Phase 2: Structured Preoperative Sedentary Behavior Reduction Program (T0 to T1) Participants will be asked to engage in the SBRPro, which includes aerobic and strength activities, in compliance with current PA guidelines. Flexibility to adapt the PA and exercise modality, duration, and intensity based on individual preferences, physical capacity, and available resources (home-based, gym-based, online platforms, or combined approaches) will be provided.
Phase 3: Structured Postoperative Sedentary Behavior Reduction Program (T2 to T4) Participants will be asked to resume SBRPro activities within the first week post-BS, adjusting the program for postoperative individual restrictions. A progressive increase in daily PA will be encouraged. For resistance exercises, participants will be advised to avoid heavy loading of incision/staple lines and to progress from light to moderate resistance as tolerated. Given the postoperative vulnerability, remote counseling will be provided as needed to enhance safety. The same weekly PA diary-based monitoring will be requested.
Physical Activity Monitoring and Adherence Assessment SBRPro adherence will be assessed through a structured weekly PA diary using a simple online form. The form will collect self-reported data on average daily sedentary time (minutes per day), total time spent in light, moderate, and vigorous physical activity (minutes per week), and the number of days per week engaged in resistance training. The form will also include a subsection addressing PA satisfaction/enjoyment (5-point Likert scale: 1, nothing fun; 2, little fun; 3, indifferent; 4, fun; 5, very fun), and any barriers or adverse events encountered. This weekly assessment will take place from baseline (the moment of enrolment in the study) until up to 12 months after surgery. For primary analyses, adherence subgroups, determined from the weekly PA diary, will be classified as having either an active or a sedentary lifestyle according to the most recent World Health Organization criteria. Individuals will be classified as physically active if they accumulate at least 150 minutes of moderate-intensity physical activity per week, and as sedentary if they do not meet this threshold. Participants with a sedentary lifestyle will serve as the de facto comparison group. This will enable evaluation of whether differential engagement with the SBRPro is associated with distinct clinical and functional outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women (≥ 18 years);
- •BMI of 30-45 kg/m2;
- •Scheduled for primary vertical sleeve gastrectomy or Roux-en-Y gastric bypass;
- •Capacity to provide informed consent, adequate proficiency in the national language;
- •Access to the internet and mobile phone communication.
排除标准
- •Previous bariatric surgery or gastric surgical procedure;
- •Physical incapacity or medical contraindications precluding physical fitness testing or participation (active cardiac disease, uncontrolled hypertension, severe joint disease);
- •Pregnancy or breastfeeding;
- •Inability to provide informed consent or comply with study procedures;
- •Patients with type 1 or 2 diabetes mellitus.
研究者
Marta Guimarães
MD, PhD; Bariatric Surgeon, Investigator and Assistant Professor
Hospital de Sao Sebastiao