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

Primary Purpose

Diabetes

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Intervention
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes focused on measuring Type 2 diabetes, mHealth (mobile health), Behavior Change Wheel

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Jomo Kenyatta University of Agriculture and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Glycated hemoglobin
Glycated hemoglobin in percentage (%)

Secondary Outcome Measures

Fasting Plasma Glucose (FPG)
Fasting Plasma Glucose in mg/dL
Total cholesterol (TC)
Total blood cholesterol in mg/dL
Triglycerides (TG),
Blood Triglycerides in mg/dL
High-density lipoprotein-cholesterol (HDL-C)
High-density lipoprotein-cholesterol in mmol/L
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.
Weight
Weight in meters
Height
Height in Meters
Waist-hip ratio
Waist-hip ratio in centimeters

Full Information

First Posted
July 20, 2021
Last Updated
February 14, 2022
Sponsor
KU Leuven
Collaborators
Jomo Kenyatta University of Agriculture and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05013294
Brief Title
Using mHealth (Mobile Health) to Optimize Glycemic Control in Adults With Type 2 Diabetes: Proof of Concept Study
Acronym
mHealth
Official Title
Using mHealth to Optimize Glycemic Control in Adults With Type 2 Diabetes in Nakuru County: A Proof-of-Concept Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
January 15, 2022 (Actual)
Study Completion Date
February 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
Collaborators
Jomo Kenyatta University of Agriculture and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
Type 2 diabetes, mHealth (mobile health), Behavior Change Wheel

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intervention
Other Intervention Name(s)
mHealth
Intervention Description
Text messages through a basic phone or smart phone
Primary Outcome Measure Information:
Title
Glycated hemoglobin
Description
Glycated hemoglobin in percentage (%)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Fasting Plasma Glucose (FPG)
Description
Fasting Plasma Glucose in mg/dL
Time Frame
12weeks
Title
Total cholesterol (TC)
Description
Total blood cholesterol in mg/dL
Time Frame
12 Weeks
Title
Triglycerides (TG),
Description
Blood Triglycerides in mg/dL
Time Frame
12 Weeks
Title
High-density lipoprotein-cholesterol (HDL-C)
Description
High-density lipoprotein-cholesterol in mmol/L
Time Frame
12 Weeks
Title
mHealth (mobile health) Satisfaction
Description
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.
Time Frame
12 Weeks
Title
Weight
Description
Weight in meters
Time Frame
12weeks
Title
Height
Description
Height in Meters
Time Frame
12 Weeks
Title
Waist-hip ratio
Description
Waist-hip ratio in centimeters
Time Frame
12 Weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Facility Information:
Facility Name
Jomo Kenyatta University of Agriculture and Technology
City
Nairobi
Country
Kenya

12. IPD Sharing Statement

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

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