Using mHealth (Mobile Health) to Optimize Glycemic Control in Adults With Type 2 Diabetes: Proof of Concept Study

NCT05013294 | Completed DMC

• 1 other identifier: P959-2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the efficacy of a diet-related mHealth (mobile health) intervention on glycated hemoglobin among adults with type 2 diabetes. The study hypothesizes that using mHealth influences food literacy and dietary behavior and may result in a reduction of glycated haemoglobin (HbA1c) by at least 0. 3% in 12 weeks in adults with type 2 diabetes. This study will be conducted in Nakuru County, a cosmopolitan county located in Northwestern Kenya. Participants will be eligible to be included in the study if they will meet the following criteria: (i) adults over the age of 18 years; (ii) diagnosed with type 2 diabetes in the previous 1 year and obtaining care at a participating level 4 hospital; (iii) able to read and write English or Swahili Language; (iv) currently own and able to read and send mobile text messages using any phone. Participants will be excluded if they are on dialysis or pregnant. The primary outcome measure will be HbA1c, which shall be measured at baseline and at the end of the intervention. Secondary outcome measures will include fasting plasma Glucose (FPG), total cholesterol (TC), triglycerides (TG) and high-density lipoprotein-cholesterol (HDL-C). Other secondary outcome measures will include anthropometric measurements (weight, height, waist and hip circumferences) and behaviour change (changes in dietary intake of legumes, fruits and vegetables). Additionally, mHealth satisfaction shall be assessed at 12 weeks and 24 weeks post-intervention to assess the sustainability of the intervention.

Conditions

Diabetes

Keywords

Type 2 diabetes; mHealth (mobile health); Behavior Change Wheel

Outcome Measures

Primary Outcomes (1)

• Glycated hemoglobin

  Glycated hemoglobin in percentage (%)

  12 weeks

Secondary Outcomes (8)

• Fasting Plasma Glucose (FPG)

  12weeks

• Total cholesterol (TC)

  12 Weeks

• Triglycerides (TG),

  12 Weeks

• High-density lipoprotein-cholesterol (HDL-C)

  12 Weeks

• mHealth (mobile health) Satisfaction

  12 Weeks

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will receive a total of 43 text messages. Text messages were developed using the Behavior Chang Wheel (BCW) through a systematic process linked to specific behavior change techniques. The text messages will provide practical information or guidance to influence selection and eating healthy diet for type 2 diabetes care. The text messages were either loss- or gain-framed to increase influence on behavioral decisions. Additionally, the participants will receive a text message to rate their ability on selection of food and eating of healthy diet based on the messages received in the month. The combination of the one-way and two-way messages in this group are designed to increase engagement of the participants.

Other: Intervention

Control Arm

PLACEBO COMPARATOR

The control group will continue receiving standard care in the hospitals. The control group shall also receive a reminder text messages one day prior the routine clinic appointment. The clinic appointment dates shall be derived from the hospital where the participant receives routine diabetes care.

Other: Intervention

Interventions

Intervention OTHER

Text messages through a basic phone or smart phone

Also known as: mHealth

Control Arm; Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• adults over the age of 18 years;
• diagnosed the type 2 diabetes within the previous 1 year and obtaining care at a participating level 4 hospital;
• able to read English or Swahili Language (self-reported).
• currently own and able to read and send mobile text messages using any phone;

You may not qualify if:

• are on dialysis;
• are pregnant;

Sponsors & Collaborators

• KU Leuven: lead
• Jomo Kenyatta University of Agriculture and Technology: collaborator

Study Sites (1)

Jomo Kenyatta University of Agriculture and Technology

Nairobi, Kenya

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Methods; Telemedicine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Researcher

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: August 19, 2021
• Study Start: August 23, 2021
• Primary Completion: January 15, 2022
• Study Completion: February 7, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

KE (1)