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

February 14, 2022 updated by: Moses Mokaya, KU Leuven

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Nairobi, Kenya
        • Jomo Kenyatta University of Agriculture and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. are on dialysis;
  2. are pregnant;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention
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
Text messages through a basic phone or smart phone
Other Names:
  • mHealth
PLACEBO_COMPARATOR: Control Arm
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
Text messages through a basic phone or smart phone
Other Names:
  • mHealth

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin
Time Frame: 12 weeks
Glycated hemoglobin in percentage (%)
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fasting Plasma Glucose (FPG)
Time Frame: 12weeks
Fasting Plasma Glucose in mg/dL
12weeks
Total cholesterol (TC)
Time Frame: 12 Weeks
Total blood cholesterol in mg/dL
12 Weeks
Triglycerides (TG),
Time Frame: 12 Weeks
Blood Triglycerides in mg/dL
12 Weeks
High-density lipoprotein-cholesterol (HDL-C)
Time Frame: 12 Weeks
High-density lipoprotein-cholesterol in mmol/L
12 Weeks
mHealth (mobile health) Satisfaction
Time Frame: 12 Weeks
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
Time Frame: 12weeks
Weight in meters
12weeks
Height
Time Frame: 12 Weeks
Height in Meters
12 Weeks
Waist-hip ratio
Time Frame: 12 Weeks
Waist-hip ratio in centimeters
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KU Leuven

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jomo Kenyatta University of Agriculture and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P959-2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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