Health promotion against Non-communicable diseases risk factors

Recruiting

Conditions: All the young people in the 10-30 years age group irrespective of gender and socio-economic status who or whose parents/guardians give written informed consent will be included in the study.

Registration Number: CTRI/2020/10/028700

Lead Sponsor: Indian Council of Medical Research

Brief Summary: **Background:**The key to the control of the global epidemic of NCDs is primary prevention based on comprehensive population-wide programs. In Indian context, a clear strategy of what works and how to implement it at local level is lacking.

**Novelty:**The emphasis of the proposed project is to strengthen Primary prevention of NCDs which often is neglected under the current National Health Programs.The project will be implemented in collaboration with the District Health System, utilizing the existing mechanism of VHNSC, Womenâ€™s Self-help Groups and Schools using the principles of *Participatory development* and therefore much more likely to be acceptable to the community and sustainable in the long run. The project will focus on young people (10-30 years) and EMPOWER and ENABLE them to exercise control on their health related behaviour and act for their own health. This age group is not covered under the NPCDCS program and it is during this phase of life that NCD risk factors are initiated and habits are formed which during later years become difficult to change and lead to chronic diseases. The three interventions are being evaluated to demonstrate the feasibility and efficacy of each of the intervention modalities as one or the other modality may not be feasible in different settings.

**Objective:** To develop, implement and evaluate the effect of a participatory health promotion initiative against modifiable risk factors for non-communicable diseases: obesity/pre-obesity, tobacco use, stress, unhealthy diet, physical inactivity, harmful use of alcohol, high blood pressure, high blood sugar and raised blood cholesterol.

**Methods:** A cluster field trial for Health promotion will be conducted in four Primary Health Centre (PHC) area with around 140000 population. Each of the four Primary Health Centre (PHC) in the study area will be randomly allocated to one arm - namely with school students as change agents, with VHNSC members as change agents and with Womenâ€™s Self-help group (SHG) members as change agents and the control arm. Baseline and Endline assessment for prevalence of NCD risk factors namely obesity/pre-obese, tobacco use, stress, unhealthy diets, physical inactivity, harmful use of alcohol and blood pressure, blood sugar and blood cholesterol will be conducted using the WHO STEPS approach. A sample size of 12000 participants (3000 in each arm) in the 10-30 years age group has been estimated to assess the effect of intervention and will be surveyed in both Baseline and Endline assessment. Biochemical assessment will be done in a sub-sample of 1600 (400 in each arm). The Integrated Model for Social Change using community mobilization through VHNSC, Womenâ€™s SHGs and Schools will be the key health promotion strategy. V-CaN clubs will be formed in each village and schools and a V-CaN day will be organized in all the intervention villages and schools once in every 6 months.

**Expected outcomes:**The change in magnitude of modifiable NCD risk factors namely obesity/pre-obesity, tobacco use, stress, unhealthy diet, physical inactivity, harmful use of alcohol, high blood pressure, high blood sugar and raised blood cholesterol among young people will be the primary outcome.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 12000

Inclusion Criteria

All the young people in the 10-30 years age group irrespective of gender and socio-economic status who or whose parents/guardians give written informed consent will be included in the study.

Exclusion Criteria

Young people suffering from severe illness or chronic diseases will be excluded from the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in modifiable risk factors for non-communicable diseases: obesity/pre-obesity, tobacco use, stress, unhealthy diet, physical inactivity, harmful use of alcohol, high blood pressure, high blood sugar and raised blood cholesterol.	30 months (post 24 months of intervention)

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Mahatma Gandhi Institute of Medical Sciences
🇮🇳
Wardha, MAHARASHTRA, India
Mahatma Gandhi Institute of Medical Sciences
🇮🇳Wardha, MAHARASHTRA, India
Dr Abhishek Raut
Principal investigator
7083170552
abhishekraut@mgims.ac.in