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Can a one year lifestyle change program help people with type 2 diabetes in India spend less on managing their condition

Impact of an Intensive Lifestyle Intervention Program on Out of Pocket Expenditure for the Management of Type 2 Diabetes in India- A One Year Prospective Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073292
Enrollment
100
Registered
2024-09-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: Lifestyle modification: The duration of the intervention is 1-year. Intervention will consist of 4 components- 1) Plant-based diet 2) Physical activity (strength, stamina flexibility ex

Sponsors

Freedom From Diabetes Research Foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Written informed consent. 2. Men and women aged 30-70 years. 3. Confirmed diagnosis of type 2 Diabetes- All patients on treatment with oral hypoglycemic agents and/or Insulin or any Ayurvedic anti-diabetic medications or HbA1c = 48 mmol/mol (6.5%) with or without medication. 4. Agree to examinations as per the study protocol, undergo the lifestyle intervention program & post-program evaluation. 5. Well-oriented in time, space & as a person.

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes (due to autoimmune b-cell destruction, usually leading to absolute insulin deficiency, including latent autoimmune diabetes of adulthood). 2. Specific types of diabetes due to other causes, e.g., monogenic diabetes syndromes (such as neonatal diabetes and maturity-onset diabetes of the young), and drug- or chemical-induced diabetes (such as with glucocorticoid use, in the treatment of HIV/AIDS, or after organ transplantation). 3. Gestational diabetes mellitus (diabetes diagnosed in the second or third trimester of pregnancy that was not clearly overt diabetes prior to gestation). 4. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
1. Assess the effect of the ILI program in reducing the OOP expenditure for T2D management 2. Estimate the average OOP expenditure for T2D patients.Timepoint: Out of expenditure will be measured at 2 time points- baseline and at the end of 12 months i.e. 52 weeks of the intervention—

Secondary

MeasureTime frame
1. Identify factors associated with higher OOP expenditure. 2. Evaluate the relationship between OOP expenditure, medication adherence & glycemic control.Timepoint: Out of expenditure will be measured at 2 time points- baseline & at the end of 12 months i.e. 52 weeks of the intervention—

Countries

India

Contacts

Public ContactDr Nidhi Kadam

Freedom From Diabetes Research Foundation

research@freedomfromdiabetes.org9822792772

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026