Impact of nutritional-behavioral and supervised exercise intervention following bariatric surgery: The BARI-LIFESTYLE randomized controlled trial

Abstract

Objective: The study's aim was to investigate the impact of a 12-month adjunctive lifestyle intervention on weight loss and health outcomes after bariatric surgery.

Methods: A total of 153 participants (78.4% females; mean [SD], age 44.2 [10.6] years; BMI 42.4 [5.7] kg/m² ) were randomized to intervention (n = 79) and control (n = 74). The BARI-LIFESTYLE program combined 17 nutritional-behavioral tele-counseling sessions plus once-weekly supervised exercise for 12 weeks. The primary outcome was percentage weight loss at 6 months post surgery. Secondary outcomes included body composition, physical activity levels, physical function and strength, health-related quality of life, depressive symptomatology, and comorbidities.

Results: Longitudinal analysis of the entire cohort showed significant reductions in body weight, fat mass, fat-free mass, and bone mineral density at the total hip, femoral neck, and lumbar spine (all p < 0.001). The 6-minute walk test, sit-to-stand test, health-related quality of life, and depressive symptomatology improved significantly (all p < 0.001). The time spent in moderate-to-vigorous physical activity and sedentary behavior remained the same as before surgery (both p > 0.05). There was no significant difference in the primary outcome between the intervention versus control (20.4% vs. 21.2%; mean difference = -0.8%; 95% CI: -2.8 to 1.1; p > 0.05) and no between-group differences in secondary outcomes.

Conclusions: An adjunctive lifestyle program implemented immediately after surgery had no favorable impact upon weight loss and health outcomes.

Trial registration: ClinicalTrials.gov NCT03214471.