Protocol of Randomized Controlled Trial to Evaluate the Effectiveness of Nurse‑Led Intervention on Weight Reduction among Adults with Obesity in Urban Areas of Puducherry

Abstract

Background: A large percentage of non‑communicable diseases are preventable through the reduction of behavioral risk factors which is due to physical inactivity and unhealthy diet. Reducing the burden of obesity is likely to make a substantial impact on mitigating the mortality and morbidity due to non‑communicable diseases. This study aims to evaluate the effectiveness of a nurse‑led intervention on weight reduction among urban adults. Methods: This trial is a two‑arm parallel group randomized controlled trial comparing the intervention arm‑nurse‑led intervention (NLI, n = 219) with the control arm‑general care (GC, n = 219). Participants randomized to the NLI group will receive the interventional package for 12 months which includes health education and motivational strategies during follow‑up. Baseline, 6‑month and 12‑month follow‑ups will be conducted to assess primary and secondary outcomes for both arms using the WHO Steps questionnaire. The analysis will use an intention‑to‑treat approach to examine the change in behavioral and physical and biochemical parameters. Conclusion: The nurse‑led intervention aims to provide an evidence‑based acceptable and flexible support strategy for weight reduction in obese adults. This will impart healthy life skills to adults and also improve their health status and enable an adult to take charge of their health and this will ultimately prevent or delay non‑communicable diseases. Trial Registration: Clinical Trials Registry India, CTRI/2021/12/038785. Registered prospectively with CTRI on 21/12/2021.