DiabetesmHealthNCT05013294
Using mHealth (Mobile Health) to Optimize Glycemic Control in Adults With Type 2 Diabetes: Proof of Concept Study
A study testing Intervention in people with Diabetes, run by KU Leuven at 1 site in Kenya.
Trial 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)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes
- What is being tested?
- Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteKenya
- Study dates
- 23 Aug 2021to 7 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- are on dialysis;
- are pregnant;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Intervention
- Keywords
- Type 2 diabetes, mHealth (mobile health), Behavior Change Wheel
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Also called mHealth
Text messages through a basic phone or smart phone
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin
Glycated hemoglobin in percentage (%)
Measured: 12 weeks
Secondary outcomes (8)
Fasting Plasma Glucose (FPG)
Fasting Plasma Glucose in mg/dL
Measured: 12weeks
Total cholesterol (TC)
Total blood cholesterol in mg/dL
Measured: 12 Weeks
Triglycerides (TG),
Blood Triglycerides in mg/dL
Measured: 12 Weeks
High-density lipoprotein-cholesterol (HDL-C)
High-density lipoprotein-cholesterol in mmol/L
Measured: 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.
Measured: 12 Weeks
Weight
Weight in meters
Measured: 12weeks
Height
Height in Meters
Measured: 12 Weeks
Waist-hip ratio
Waist-hip ratio in centimeters
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start23 Aug 2021
- Primary completion15 Jan 2022
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Jomo Kenyatta University of Agriculture and Technology
- Responsible party
- Principal investigator, Moses Mokaya, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013294
- Sponsor's protocol ID
- P959-2021
- Acronym
- mHealth
- Status last verified
- Feb 2022
- First submitted
- 20 Jul 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using mHealth to Optimize Glycemic Control in Adults With Type 2 Diabetes in Nakuru County: A Proof-of-Concept Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05013294
- Acronym / sponsor ID
- mHealth / P959-2021
- Conditions
- Diabetes
- Keywords
- Type 2 diabetes, mHealth (mobile health), Behavior Change Wheel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Jomo Kenyatta University of Agriculture and Technology
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: InterventionThe 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. |
| Control Arm | Placebo comparator | Other: InterventionThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (2 listed)
- are on dialysis;
- are pregnant;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionAlso: mHealthText messages through a basic phone or smart phone | Other | Control Arm, Intervention |
Primary outcome
Glycated hemoglobin
Time frame: 12 weeks
Glycated hemoglobin in percentage (%)
8 secondary outcomes
Fasting Plasma Glucose (FPG)
Time frame: 12weeks
Total cholesterol (TC)
Time frame: 12 Weeks
Triglycerides (TG),
Time frame: 12 Weeks
High-density lipoprotein-cholesterol (HDL-C)
Time frame: 12 Weeks
mHealth (mobile health) Satisfaction
Time frame: 12 Weeks
Weight
Time frame: 12weeks
Height
Time frame: 12 Weeks
Waist-hip ratio
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Diabetes, run by KU Leuven at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.