Effectiveness of Text Messaging Intervention to Improve Dietary Behaviors Among Patients with Type 2 Diabetes Mellitus in Low Resource Area of Sabah (DTEXT-SBH)

NCT06587581 | Not Yet Recruiting DMC

• 1 other identifier: RSCH ID-24-01119-NHX
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if sending three (3) text messages per week over a six (6) months period to people with Type 2 Diabetes in areas with lack access to dietitian could help them stick to a healthier diet. The main questions it aims to answer are:

• Does a mobile phone text-message intervention improve dietary adherence among T2DM patients?
• Does a mobile phone text-message intervention improve HbA1c and self-management among T2DM patients? Researchers will compare dietary adherence, HbA1c changes and self-management behaviors between the usual care group and intervention group. Participants will:
• Be given three (3) text messages per week over a six (6) months period for the intervention group
• Both usual care and intervention group will be given standard medical nutrition therapy at baseline, 3rd and 6th months visits to the clinic

Conditions

Type 2 Diabetes Mellitus(T2DM)

Keywords

type 2 diabetes mellitus; lack access to dietitian; eHealth; Dietary adherence; low resource area

Outcome Measures

Primary Outcomes (1)

• Comparison of dietary adherence at 3-month and 6-month between the usual care group and intervention group

  Dietary adherence to diabetic diet will be evaluated against a modified healthy eating index (HEI). A 3-day dietary record methodology (2 weekdays and 1 weekend) will be used and analyzed based on Malaysian and Singapore Food Composition Databases. The modified version of HEI used in this study consists of 14 components. Sum scores of each component yields and overall score of diet quality which will be converted into scale of zero to 100. A higher the HEI score indicates a greater adherence. The overall dietary adherence will be classified as low (below 51%), needing improvement (51-80%), or high (more than 80 points)

  Baseline, 3-month, and 6-month

Secondary Outcomes (2)

• Comparison of glycated hemoglobin (HbA1c) at 3-month and 6-month between the usual care group and intervention group

  Baseline, 3-month, and 6-month

• Comparison of self-management behavior at 3-month and 6-month between the usual care group and intervention group

  Baseline, 3-month, and 6-month

Study Arms (2)

T2DM Medical Nutrition Therapy

ACTIVE COMPARATOR

Participants from control groups will receive the usual care, which will be a three-monthly nutrition consultation by a visiting dietitian

Other: Control Group

T2DM Medical Nutrition Therapy and Text Messages

EXPERIMENTAL

Participants from the intervention group will receive the usual care and an additional three text messages per week via WhatsApp over the 6-month intervention period

Other: Intervention Group

Interventions

Control Group OTHER

Participants from the intervention group will receive the usual care over the 6-month intervention period

T2DM Medical Nutrition Therapy

Intervention Group OTHER

Participants from the intervention group will receive the usual care and an additional three text messages per week via WhatsApp over the 6-month intervention period

T2DM Medical Nutrition Therapy and Text Messages

Eligibility Criteria

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

You may qualify if:

• have type 2 diabetes.
• own a mobile phone.
• able to use WhatsApp.
• able to read and speak Bahasa Malaysia.
• have an HbA1c level above 7.0%.
• have not seen a dietitian in the previous 6 months.

You may not qualify if:

• individuals with type 1 diabetes mellitus and gestational diabetes mellitus.
• patients with cognitive impairment affecting memory, attention, language, and problem-solving skills.
• those with advanced diabetic complications, such as kidney failure and neuropathy.
• individuals lacking regular access to a mobile phone or with poor network connectivity.
• pregnant individuals or those planning to get pregnant in the next 6 months, as well as those currently nursing.
• individuals with major illnesses like cancer or advanced heart disease.
• those planning major surgery or gastric bypass in the next 6 months.
• institutionalized individuals, such as those in nursing homes, old folks\' homes, or imprisoned.

Sponsors & Collaborators

• Universiti Malaysia Sabah: lead

Study Sites (1)

Ranau District Hospital and Klinik Kesihatan Kundasang

Kota Kinabalu, Sabah, 89308, Malaysia

Location

Related Publications (2)

• Arora S, Peters AL, Burner E, Lam CN, Menchine M. Trial to examine text message-based mHealth in emergency department patients with diabetes (TExT-MED): a randomized controlled trial. Ann Emerg Med. 2014 Jun;63(6):745-54.e6. doi: 10.1016/j.annemergmed.2013.10.012. Epub 2013 Nov 11.

  PMID: 24225332 BACKGROUND

• Ramachandran A, Snehalatha C, Ram J, Selvam S, Simon M, Nanditha A, Shetty AS, Godsland IF, Chaturvedi N, Majeed A, Oliver N, Toumazou C, Alberti KG, Johnston DG. Effectiveness of mobile phone messaging in prevention of type 2 diabetes by lifestyle modification in men in India: a prospective, parallel-group, randomised controlled trial. Lancet Diabetes Endocrinol. 2013 Nov;1(3):191-8. doi: 10.1016/S2213-8587(13)70067-6. Epub 2013 Sep 11.

  PMID: 24622367 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Esther Alim Albert

CONTACT

6088320000; esther_alim_mn22@iluv.ums.edu.my

Esther Alim Albert

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: REGISTERED DIETITIAN

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)