Effectiveness of a behavior change intervention package on health literacy of behavioural risk factors of non-communicable diseases among health care assistants of government hospitals in Colombo district: Cluster randomized controlled trial.

Category Primary study
Registry of TrialsSLCTR
Year 2023
INTERVENTION: a) Study design: Cluster randomized controlled trial b) Study setting: This study will be conducted in hospitals in Colombo district (Hospitals in Colombo district attached as annexure III) c) Study population: Health care assistants working in government hospitals in Colombo district d). Randomization: ‐ Ten units per arm (Intervention and control arm) ‐ Generating a random allocation sequence using a random number table ‐ Allocation concealment: Twenty Hospitals will be selected using stratified cluster sampling method based on type of hospitals in Colombo district. Each hospital will be taken as cluster and there will be twenty clusters (hospitals). Hospitals will be allocated to the intervention and the control groups by an independent person (Consultant Community Physician attached to MoH), who will not be involved in selection of participants, or any other activity related to this study (Concealment of allocation). Required number of HCAs will be selected randomly from the pay roll of all HCAs attached to the hospital. It will be selected in three steps within the hospital. Step I: All HCAs will be listed out based on pay roll. Step II: Eligible HCAs will be selected based on inclusion and exclusion criteria. Step III: Required number of HCAs will be selected using simple random sampling (random table). Intervention: Behaviour change Intervention Package (BCIP) will be delivered to the participants of the intervention arm. This package includes multiple interventions such as lectures, role playing sessions, brainstorming sessions, and small group discussions. This package will be delivered as two sessions per week for 8 weeks, total of sixteen sessions. Further it consists of Curriculum, Facilitator guide, Participants’ handbook, and Power poi CONDITION: Health Literacy PRIMARY OUTCOME: HL.NCD: Health Literacy tool to assess NCD behavioral risk factors. ; It was developed and validated in the first component of this research. [12 weeks from initial assessment ; ]; SECONDARY OUTCOME: Secondary outcomes are behaviour change of; pattern/frequency of Diet, frequency of physical; activity, status/frequency of tobacco use and; status/frequency of alcohol intake. It will be; measured using STEP‐wise‐approach‐toSurveillance (STEPS) of NCD risk factor; questionnaire. [12 weeks from initial assessment ]; INCLUSION CRITERIA: ‐ Permanent staff who have been working as HCA more than si Xmonths ‐ Age of HCAs would be in between 18 years to 45 years. ‐ Both male and female
Epistemonikos ID: 26de9011f6b0879a32e27ee507d741728cdc2011
First added on: Aug 26, 2024