SUPPORT -Strategies for non-communicable disease prevention in select populations in different regions of India

Details

a) Background: NCDs, predominantly CVDs have the highest mortality and morbidity with huge costs to individuals and globally as acknowledged by the global health authorities. NCDs are exponentially growing and there is a crucial need to curb the increasing burden.

b) Aim/objective:

Among select vulnerable populations of any gender aged > 30 years, with moderate to high risk for NCDs from different regions in India,

Primary objective:

  1. To evaluate the effect of multiple interventions centered on improving use of evidence based therapeutic lifestyle changes (TLC), medication adherence, and theory driven behaviour change on aggregate NCD risk at six months.
  2. To build capacity at the community for implementation of NCD prevention strategies

Secondary objective:

To evaluate the interventions for feasibility and acceptability and using implementation research methods (RE-AIM)

c) Methods:

It is a non- randomized quasi-experimental study design.

Setting: Identified vulnerable populations belonging to different regions of India. These populations have either a social-economic or geographical inequity that makes them vulnerable. Sites include:

1. Tribal Health Initiative, Sittilingi, Tamil-Nadu

2. Maya bazaar urban slum community, Bangalore

3. Emmaus Swiss Referral Hospital, Palamaner

4. SANGAMA foundation, Hassan

5. Swami Vivekananda Youth Movement, Hoskote

6. Gauri Research Centre, Srinagar, Kashmir

7. The Community Health and Training Centre (CHTC), Mugalur

Study Population

Inclusion Criteria:

Select vulnerable populations aged >30years of any gender from different regions of India with known H/O or Diagnosed at screening with hypertension, diabetes, COPD, depression, anxiety, or common cancers as oral, breast and cervical cancer on or off treatment

Any of the lifestyle related NCD risk factors such as tobacco usage, obesity, Physical inactivity, dyslipidaemias, and alcohol abuse

Exclusion criteria

Severe cognitive impairment without a primary caregiver.

Study outcomes

Primary Outcome:

Change in NCD Risk factor before and after intervention.

Secondary Outcomes:

Before and after intervention,

  1. Change in the biochemical parameters that include fasting and post-prandial blood sugar, HbA1c and lipid profile.
  2. Clinical NCD outcomes – NCD related hospitalisation or death (All-cause mortality)
  3. Implementation metrics – RE-AIM framework
  4. Feasibility outcomes – ICER

The outcomes will also be measured after 6 months and at one year after the completion of the intervention to assess sustainability of the interventions.

e) Sample size: 350

f) Study update as on 28th Dec 2023: Out of the 7 sites, 4 are active and recruiting and are at different stages of follow-ups.

Updated on January 2024

 

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