Effectiveness of Automated Mobile Phone Based Text Messaging on the Improvement of Glycaemic Outcomes

NCT02643277 | Completed DMC

• 1 other identifier: IDRFARH001
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief Summary

In India, the high diabetes prevalence and cost of its management relative to their personal income render the country an appropriate environment to seek and test new, less expensive aids to care. Education and motivation to induce behavioural modification, are important components of care. Conventional diabetes education programmes involving personal contact methods are useful but expensive. Compliance with medications is also important and there are data to suggest that compliance is low in people with established type 2 diabetes (there is little information on those with recently diagnosed disease). Mobile phones could provide an inexpensive and scaleable delivery vehicle for components of care. There are now more than 5 billion wireless subscribers and 70% of them live in low and middle income countries. Mobile phone ownership is high in India and an increasing proportion now has Mobile phones and/or home computers. The investigators plan a clinical trial in India to assess whether there is benefit from an enhanced text message intervention delivered by mobile phone in people newly diagnosed with Type 2 diabetes. The message content will be directed to behavioural modification, as with our diabetes prevention studies, and will attempt to improve compliance with drug therapy and other aspects of care, as with our studies in people with established diabetes. The investigators shall compare effects on glycaemia, other cardiovascular risk factors, lifestyle behaviour and quality of life, with those observed in people with type 2 diabetes receiving standard care.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Comparison of the glycaemic outcome measured as improvement in HbA1c (≤ 7.0% (53mmol/mol)) in the intervention group in comparison with the conventional care.

  2 years

Secondary Outcomes (7)

• Changes in body mass index

  Baseline and 2 years

• Changes in blood pressure

  Baseline and 2 years

• Changes in fasting and postprandial plasma glucose

  Baseline and 2 years

• Changes in lipid profile

  Baseline and 2 years

• Improvement in quality of life

  Baseline and 2 years

Study Arms (2)

Conventional care

OTHER

Conventional care is comprised of a one-to-one interview by a trained research personnel on diet and exercise advice at baseline and during every visit. The goals were to reduce portion size (total calories) and, to avoid simple sugars and refined carbohydrates, reduce total fat intake, restrict use of saturated fat, include more fibre rich food-(e.g., whole grains, legumes, vegetables, and fruits).

Other: Conventional care

Mobile phone text messaging

EXPERIMENTAL

The intervention will receive text messages delivered by an automated text messaging manager. The message content will be designed to induce lifestyle modification (diet and physical activity) and will be motivational, based on the content which has been proven to be effective in reducing progression to diabetes in people with pre-diabetes. Other text messages will aim to improve drug compliance and disease monitoring. The messages provide tips and suggestions, and positive reinforcement or encouragement, for improving lifestyle behaviors and compliance with therapy.

Behavioral: Mobile phone text messaging

Interventions

Mobile phone text messaging BEHAVIORAL

The intervention will be text messages delivered by an automated text messaging manager. The message content will be designed to induce lifestyle modification (diet and physical activity) and will be motivational, based on the content which has been proven to be effective in reducing progression to diabetes in people with pre-diabetes. Other text messages will aim to improve drug compliance and disease monitoring, based on our pilot studies in India. The control arm will receive conventional management, according to local guidelines in the Indian centers, which in all cases are compatible with those of the International Diabetes Federation.

Mobile phone text messaging

Conventional care OTHER

Conventional care is comprised of a one-to-one interview by a trained research personnel on diet and exercise advice at baseline and during every visit. The goals were to reduce portion size (total calories) and, to avoid simple sugars and refined carbohydrates, reduce total fat intake, restrict use of saturated fat, include more fibre rich food-(e.g., whole grains, legumes, vegetables, and fruits).

Conventional care

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Newly diagnosed Type 2 Diabetes Mellitus patients not receiving any medication for diabetes.
• Patients who consent to participate in the study
• Both sexes of age ≥ 20 and ≤ 60 years.
• Having an HbA1c level of ≥ 6.5 % (48 mmol/mol) on diagnosis
• Willing to report periodically for investigations during the study period
• Ability to read and understand messages.

You may not qualify if:

• Type 1 Diabetes
• Major illness - such as Cancer, Cardiovascular Disease, Chronic liver or kidney disease on diagnosis of diabetes.
• Disorders with cognitive impairment, severe depression or mental imbalance.
• Physical disability that would prevent regular physical activity.
• Participants unwilling to participate in the study.
• Participants who do not possess a mobile phone.
• Participants not able to read and understand SMS.
• Participants below the age of 20 years and above the age of 60 years.

Sponsors & Collaborators

• India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals: lead

Study Sites (1)

Dr.A.Ramachandran's Diabetes Hospitals

Chennai, Tamil Nadu, 600 008, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ambady Ramachandran, Prof

  Chairman, India Diabetes Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: December 31, 2015
• Study Start: December 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 2, 2019

Record last verified: 2019-04

Locations

IN (1)