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

Study Overview
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Brief Summary
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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.

Detailed Description
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A sample size of 60 a-priori (n=30 intervention, n=30 control arm) was determined to assess feasibility of text messaging in optimizing glycemic control. It is anticipated that this proof-of-concept study will obtain parameters that will be used in determining a robust power calculation for a fully powered efficacy trial. Purposive sampling will be used to select two hospitals, one in a rural setting and another in an urban setting in Nakuru County, Kenya. Multistage random sampling using computer-generated list of random numbers will then be applied to randomly assign 15 participants to either the intervention arm or control arm. The hospitals' diabetes registers will be used to select patients on regular diabetes care from the hospital patient records. The intervention group will receive a total of 43 text messages developed using the Behavior Change Wheel (BCW) approach. The text messages that are linked to specific behavior change techniques will provide practical information or guidance to influence selection and eating of healthy diet for type 2 diabetes. Additionally, two-way text messages, will be sent to study participants to rate their ability on selection of food and eating of healthy diet based on the messages received after every 4 weeks. The combination of the one-way and two-way messages in this in the intervention arm are designed to increase engagement of the participants. The control group will continue receiving standard care in the hospitals. This group shall also receive clinic appointment reminder text messages one day prior to the actual date. Quantitative data will be analyzed by the intention to treat principle. Various patient characteristics and primary outcome measures, including anthropometric and biochemical measurements (HbA1c, Fasting Blood Glucose (FBG), lipid profiles) at baseline will be summarized using descriptive statistics. The descriptive statistics will include means and standard deviations for continuous variables and proportions for categorical variables. HbA1c levels will be compared at 12 weeks between the two arms using an ANCOVA which will control for baseline HbA1c levels. The intervention and the control groups will be followed-up for six months to assess sustainability and mHealth satisfaction of the intervention. One-way and two-way text messaging data will be analyzed descriptively. Subgroup analysis per hospital and participant socio-demographics including age, sex, education and income levels will be conducted. All statistical analyses will be performed using R version 4.0.3.

Official Title
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Using mHealth to Optimize Glycemic Control in Adults With Type 2 Diabetes in Nakuru County: A Proof-of-Concept Randomized Controlled Trial

Conditions
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Diabetes

Intervention / Treatment
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* Other: Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Exclusion Criteria: are on dialysis; are pregnant;
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Text messages through a basic phone or smart phone<br>* Other names: mHealth;|
| Placebo Comparator: Control Arm<br>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<br>* Text messages through a basic phone or smart phone<br>* Other names: mHealth;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated hemoglobin | Glycated hemoglobin in percentage (%) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Plasma Glucose (FPG) | Fasting Plasma Glucose in mg/dL | 12weeks | 
| Total cholesterol (TC) | Total blood cholesterol in mg/dL | 12 Weeks | 
| Triglycerides (TG), | Blood Triglycerides in mg/dL | 12 Weeks | 
| High-density lipoprotein-cholesterol (HDL-C) | High-density lipoprotein-cholesterol in mmol/L | 12 Weeks | 
| mHealth (mobile health) Satisfaction | User satisfaction shall use a 5-point likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree. A score of 5 (Strongly Agree) means a high level of satisfaction, which is a better outcome. A low score of 1 (Strongly Disagree) means a low satisfaction level and therefore a worst outcome. | 12 Weeks | 
| Weight | Weight in meters | 12weeks | 
| Height | Height in Meters | 12 Weeks | 
| Waist-hip ratio | Waist-hip ratio in centimeters | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, mHealth (mobile health), Behavior Change Wheel