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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Portugal
Unidade Local de Saúde de Entre Douro e Vouga
RECRUITING
Santa Maria Da Feira
Contact Information
Primary
Unidade Local de Saúde Entre Douro e Vouga
geral@ulsedv.min-saude.pt
+351 256 379 700
Time Frame
Start Date: 2026-04-20
Estimated Completion Date: 2031-04-20
Participants
Target number of participants: 72
Treatments
Experimental: Adherent group
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.
No_intervention: Non-adherent group
Non-adherence to the sedentary behavior reduction program.
Related Therapeutic Areas
Sponsors
Collaborators: Unidade Multidisciplinar de Investigação Biomédica, Universidade do Porto, Universidade Lusófona - Centro Universitário do Porto, COFAC Cooperativa de Formacao e Animacao Cultural CRL (Portugal)
Leads: Hospital de Sao Sebastiao

This content was sourced from clinicaltrials.gov