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

NCT07663942 | Recruiting DMC

• 1 other identifier: ULSEDV
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity (Disorder)

Keywords

physical inactivity; weight loss; quality of life; adiposity; skeletal muscle; adipose tissue

Outcome Measures

Primary Outcomes (3)

• Percentage of total weight loss (%TWL)

  Primary clinical outcome evaluating the percentage of total weight loss, measuring weight in kilograms before and after surgery.

  Postoperative reassessment: T3 (3±1 months after surgery) and T4 (12±2 months after surgery).

• Obesity-related complications and diseases (ORCD)

  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.

  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).

• Changes in health-related quality of life (QoL)

  Primary clinical outcome assessed by using the SF-12 (12-item Short Form Health Survey), a validated questionnaire.

  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).

Secondary Outcomes (5)

• Body composition

  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).

• Muscle strength

  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).

• Cardiorespiratory fitness (CRF)

  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).

• Identification of proteomic differences in skeletal muscle and visceral adipose tissue associated with adherence at the time of surgery

  Intra-operative: T2

• Longitudinal blood metabolomic adaptations

  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).

Study Arms (2)

Adherent group

EXPERIMENTAL

Participants will be instructed in the sedentary behavior reduction program (SBRPro) and asked to maintain weekly physical activity diaries throughout the pre- and post-operative periods.

Behavioral: Sedentary behavior reduction program on physical fitness.

Non-adherent group

NO INTERVENTION

Non-adherence to the sedentary behavior reduction program.

Interventions

Sedentary behavior reduction program on physical fitness. BEHAVIORAL

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.

Adherent group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Sao Sebastiao: lead
• Universidade Lusófona - Centro Universitário do Porto: collaborator
• Unidade Multidisciplinar de Investigação Biomédica, Universidade do Porto: collaborator
• COFAC Cooperativa de Formacao e Animacao Cultural CRL (Portugal): collaborator

Study Sites (1)

Unidade Local de Saúde de Entre Douro e Vouga

Santa Maria da Feira, 4520-211, Portugal

RECRUITING

MeSH Terms

Conditions

Obesity; Sedentary Behavior; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Body Weight Changes

Central Study Contacts

Unidade Local de Saúde Entre Douro e Vouga

CONTACT

+351 256 379 700; geral@ulsedv.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD; Bariatric Surgeon, Investigator and Assistant Professor

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: June 23, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): October 20, 2030
• Study Completion (Estimated): April 20, 2031
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

PT (1)