Targeting Sedentary Behavior Reduction and Physical Fitness Enhancement in Women Before and Beyond Bariatric Surgery- BARIMOV Study Protocol

Condition(s) studied

Investigational drug(s) / intervention(s)

Sedentary behavior reduction program on physical fitness.: The BARIMOV protocol incorporates this evidence through a structured, online sedentary behavior reduction program (SBRPro) that emphasizes substituting sedentary behavior with physical activity throughout the day.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Percentage of total weight loss (%TWL) — Postoperative reassessment: T3 (3±1 months after surgery) and T4 (12±2 months after surgery).
  Primary clinical outcome evaluating the percentage of total weight loss, measuring weight in kilograms before and after surgery.
• Obesity-related complications and diseases (ORCD) — Preoperative assessments: T0 (6±3 months before surgery), and T1 (2 weeks±3 days before surgery). Postoperative reassessment: T3 (3±1 months after surgery) and T4 (12±2 months after surgery).
  Pre- and post-operative status comparison through in-person clinical evaluations and routine laboratory analyses, including physical examination findings and longitudinal changes in pharmacological treatment requirements. ORCD will be assessed as a composite outcome including the presence of the following conditions, defined using a standardized criterion: Type 2 diabetes mellitus: HbA1c≥6.5% or use of glucose-lowering medication; Hypertension: systolic BP≥140 mmHg, diastolic BP≥90 mmHg, or antihypertensive treatment; Dyslipidemia: LDL-C, HDL-C, or triglycerides outside guideline thresholds or lipid-lowering therapy; Obstructive sleep apnea: confirmed by polysomnography \[AHI≥5 events/hour\]; Gastroesophageal reflux disease (GERD): heartburn and/or acid regurgitation occurring≥2 times per week or current use of proton pump inhibitors (PPIs) for reflux symptoms with prior physician diagnosis of GERD; Metabolic syndrome: defined according to NCEP ATP ΙΙΙ criteria.
• Changes in health-related quality of life (QoL) — Preoperative assessments: T0 (6±3 months before surgery), and T1 (2 weeks±3 days before surgery). Postoperative reassessment: T3 (3±1 months after surgery) and T4 (12±2 months after surgery).
  Primary clinical outcome assessed by using the SF-12 (12-item Short Form Health Survey), a validated questionnaire.

Trial sites (1)