Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes patients, Diabetes self-management, Cardiovascular diseases awareness, Home food environment, Text message
Brief summary
In this project the investigators examined the impact of diabetes self-management education using text messaging on increasing awareness of CVD risk perception, dietary intake, physical activity, and diabetes self-management among adults with type 2 diabetes using a quasi experimental design. The study sample included 79 adult type 2 diabetes patients (30 years or older). The recruited adult type 2 diabetes patients were assigned into the intervention group (40 participants) and control group (39 participants). The intervention group received 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks). The messages consisted of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages were derived from the American Association of Diabetes Educator (AADE) handouts (Reducing Risks, Monitoring, Healthy Coping, Problem Solving, Taking Medication, Healthy Eating, and Exercise) Text messages were positive and motivating and included a link to a specific AADE7 handout that allows participants to open and retrieve the specific AADE7 handout. The control group did not receive text messages. The participants (both intervention and control group) completed surveys at baseline (before study begins) and at the conclusion of the study (at three month of the intervention) about their dietary and lifestyle habits, diabetes self-care management activities, and awareness of cardiovascular diseases. We collected also collect patient's self-report Hemoglobin A1C values at baseline and at the conclusion of the study (at three month of the intervention).
Detailed description
Type 2 diabetes and its complications have become an important public health problem, affecting nearly 350 million adults worldwide. However, successfully managing type 2 diabetes through proper nutrition and healthy lifestyles remains challenging for many diabetes patients. In this proposed project the investigators examined the impact of diabetes self-management education using text messaging on increasing awareness of CVD risk perception, dietary intake, physical activity, and diabetes self-management, and quality of life among adults with type 2 diabetes among adults with Type 2 diabetes using a quasi experimental design. The study sample included 79 adult type 2 diabetes patients (30 years or older). Inclusion criteria for the study sample of adult type II diabetes patients were: adults ages 30 or older, English speaking, and Hemoglobin A1C levels \> 6.5%. Adult type 2 diabetes patients were recruited from the Center for Diabetes & Nutritional Health, an outpatient diabetes clinic of Methodist Hospital in Omaha with the assistance of Certified Diabetes Educators and Registered Dietitians. Diagnosis of type 2 diabetes were based on patient self-report and verified by the Co-Primary Investigator (who is Certified Diabetes educator and registered dietitian at the Methodist Hospital. The recruited adult type 2 diabetes patients were assigned into the intervention group (40 participants) and control group (39 participants). The intervention group received 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks). The messages consisted of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages were derived from the American Association of Diabetes Educator (AADE) handouts (Reducing Risks, Monitoring, Healthy Coping, Problem Solving, Taking Medication, Healthy Eating, and Exercise) Text messages were positive and motivating and included a link to a specific AADE7 handout that allows participants to open and retrieve the specific AADE7 handout. Text messages were sent by the project investigators to the participants in the intervention group via a free computer-based text messaging service. The computer was password protected and can only be accessed by the investigators. Participant's phone numbers used for text message intervention were kept private. Only investigators and research assistant know the participant's cell phone numbers used for text message intervention and each participant's cell number was not shared with anyone else including other study participants. Text messages were sent by the project investigators or research assistant to the patients and were one-way text messages, meaning that patient did not need to reply to the text messages. If a patient had a medical concern about his/her diabetes, he/she was advised not to send a text message to the investigator, but to contact his/her physician or call 911 instead. The control group did not receive text messages. The participants (both intervention and control group) completed surveys at baseline (before study begins) and at the conclusion of the study (at three month of the intervention) about their dietary and lifestyle habits, diabetes self-care management, awareness of cardiovascular diseases and home food environment. The investigators also collected patient's self-report Hemoglobin A1C values at baseline and at the conclusion of the study (at three month of the intervention).
Interventions
The messages will consist of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages will be derived from the American Association of Diabetes Educator (AADE) handouts (Reducing Risks, Monitoring, Healthy Coping, Problem Solving, Taking Medication, Healthy Eating, and Exercise). The control group will not receive text messages
Sponsors
Study design
Eligibility
Inclusion criteria
* Self-report adult type 2 diabetes patients * Adults ages 30 or older * English speaking * Self-report Hemoglobin A1C \> 6.5% * Have a cell phone able to receive text messages
Exclusion criteria
* Individuals without Type 2 diabetes * Less than 30 years of age * Self-report Hemoglobin A1C less than 6.5% * Does not have a cell phone to receive text messages * Individuals who don't speak and understand English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eat >= 5 Servings Fruit and Vegetables | Three months | Self report survey question (days/week) |
| Self-Care Activities: Healthy Eating | Three months | An average of summary scores of the four self-report heathy eating related items in the category (days/over the last 7 days) |
| Diabetes Self-care Activity: Exercise | Three months | Average of two self-report survey questions related to exercise in the category (days/over the last 7 days) |
| Self-care Activity: Blood Glucose Testing | three months | Average of two self-report survey question items related to blood glucose testing in the category (days over the last seven days) |
| Self-care Activity: Medication Adherence | three months | Self-report survey question (days over the last seven days) |
| Self-care Activity: Foot Care | three months | Average of four self-report survey questions of the category (days over the last seven days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-report Hemoglobin A1C | Three months | Self-report hemoglobin for diabetes status |
| Frequency of Concern of CVD Event | Three months | Self-report question to measure a patient's cardiovascular disease awareness: Frequency of concern of CVD event |
| Total Carbohydrate | One month | A self-report food frequency questionnaire over the past month |
| Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity | Three months | A Self-report physical activity measure over the past month. The activities were converted to metabolic equivalent (MET: a measure of exercise intensity based on oxygen consumption) minutes per week for moderate/vigorous physical activity |
| Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years | Three months | Self report survey question |
| Degree of Concern of CVD Event in Lifetime | Three months | Self-report survey question on Cardiovascular disease (CVD) awareness: degree of concern of CVD event in lifetime |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Text Messaging Intervention group received three text messages per week for 12 weeks | 40 |
| Control Control group did not receive text messages | 39 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 4 |
Baseline characteristics
| Characteristic | Text Messaging | Control | Total |
|---|---|---|---|
| Age, Customized | 58.8 years STANDARD_DEVIATION 10.6 | 55.7 years STANDARD_DEVIATION 12.2 | 56.9 years STANDARD_DEVIATION 11.4 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized other | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 33 Participants | 36 Participants | 69 Participants |
| Region of Enrollment United States | 40 Participants | 39 Participants | 79 Participants |
| Sex: Female, Male Female | 26 Participants | 26 Participants | 52 Participants |
| Sex: Female, Male Male | 14 Participants | 13 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 39 |
| other Total, other adverse events | 0 / 40 | 0 / 39 |
| serious Total, serious adverse events | 0 / 40 | 0 / 39 |
Outcome results
Diabetes Self-care Activity: Exercise
Average of two self-report survey questions related to exercise in the category (days/over the last 7 days)
Time frame: Three months
Population: Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Text Messaging | Diabetes Self-care Activity: Exercise | Baseline | 5.13 days/week (min: 0 days; Max: 7 days) | Standard Error 0.62 |
| Text Messaging | Diabetes Self-care Activity: Exercise | post-intervention | 4.48 days/week (min: 0 days; Max: 7 days) | Standard Error 0.66 |
| Control | Diabetes Self-care Activity: Exercise | Baseline | 4.91 days/week (min: 0 days; Max: 7 days) | Standard Error 0.66 |
| Control | Diabetes Self-care Activity: Exercise | post-intervention | 4.25 days/week (min: 0 days; Max: 7 days) | Standard Error 0.69 |
Eat >= 5 Servings Fruit and Vegetables
Self report survey question (days/week)
Time frame: Three months
Population: Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Text Messaging | Eat >= 5 Servings Fruit and Vegetables | 4.1 day/week (min: 0 days; max 7 days) | Standard Error 0.4 |
| Control | Eat >= 5 Servings Fruit and Vegetables | 4.0 day/week (min: 0 days; max 7 days) | Standard Error 0.3 |
Self-Care Activities: Healthy Eating
An average of summary scores of the four self-report heathy eating related items in the category (days/over the last 7 days)
Time frame: Three months
Population: Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Text Messaging | Self-Care Activities: Healthy Eating | Baseline | 4.23 days/week (min: 0 days; Max: 7 days) | Standard Error 0.38 |
| Text Messaging | Self-Care Activities: Healthy Eating | post-intervention | 4.61 days/week (min: 0 days; Max: 7 days) | Standard Error 0.4 |
| Control | Self-Care Activities: Healthy Eating | Baseline | 4.67 days/week (min: 0 days; Max: 7 days) | Standard Error 0.4 |
| Control | Self-Care Activities: Healthy Eating | post-intervention | 4.60 days/week (min: 0 days; Max: 7 days) | Standard Error 0.41 |
Self-care Activity: Blood Glucose Testing
Average of two self-report survey question items related to blood glucose testing in the category (days over the last seven days)
Time frame: three months
Population: Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Text Messaging | Self-care Activity: Blood Glucose Testing | Baseline | 5.09 days/ week (min: 0 days; max: 7 days)) | Standard Error 0.64 |
| Text Messaging | Self-care Activity: Blood Glucose Testing | post-intervention | 5.27 days/ week (min: 0 days; max: 7 days)) | Standard Error 0.68 |
| Control | Self-care Activity: Blood Glucose Testing | Baseline | 5.93 days/ week (min: 0 days; max: 7 days)) | Standard Error 0.69 |
| Control | Self-care Activity: Blood Glucose Testing | post-intervention | 5.63 days/ week (min: 0 days; max: 7 days)) | Standard Error 0.7 |
Self-care Activity: Foot Care
Average of four self-report survey questions of the category (days over the last seven days)
Time frame: three months
Population: Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Text Messaging | Self-care Activity: Foot Care | Baseline | 4.17 day/week (min: 0 days; max 7 days) | Standard Error 0.41 |
| Text Messaging | Self-care Activity: Foot Care | post-intervention | 4.89 day/week (min: 0 days; max 7 days) | Standard Error 0.44 |
| Control | Self-care Activity: Foot Care | Baseline | 4.22 day/week (min: 0 days; max 7 days) | Standard Error 0.45 |
| Control | Self-care Activity: Foot Care | post-intervention | 4.18 day/week (min: 0 days; max 7 days) | Standard Error 0.45 |
Self-care Activity: Medication Adherence
Self-report survey question (days over the last seven days)
Time frame: three months
Population: Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Text Messaging | Self-care Activity: Medication Adherence | Baseline | 5.75 day/week (min: 0 days; max 7 days) | Standard Error 0.22 |
| Text Messaging | Self-care Activity: Medication Adherence | post-intervention | 5.73 day/week (min: 0 days; max 7 days) | Standard Error 0.23 |
| Control | Self-care Activity: Medication Adherence | Baseline | 5.83 day/week (min: 0 days; max 7 days) | Standard Error 0.23 |
| Control | Self-care Activity: Medication Adherence | post-intervention | 5.67 day/week (min: 0 days; max 7 days) | Standard Error 0.24 |
Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years
Self report survey question
Time frame: Three months
Population: Chi-square
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Text Messaging | Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years | post-intervention | No or low concern | 19 Participants |
| Text Messaging | Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years | Baseline | No or low concern | 24 Participants |
| Text Messaging | Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years | post-intervention | Highly concern | 5 Participants |
| Text Messaging | Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years | Baseline | Somewhat concern | 13 Participants |
| Text Messaging | Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years | post-intervention | Somewhat concern | 11 Participants |
| Text Messaging | Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years | Baseline | Highly concern | 3 Participants |
| Text Messaging | Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years | post-intervention | Not answer | 5 Participants |
| Text Messaging | Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years | Baseline | Not answer | 0 Participants |
| Control | Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years | post-intervention | Not answer | 4 Participants |
| Control | Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years | post-intervention | No or low concern | 24 Participants |
| Control | Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years | post-intervention | Somewhat concern | 8 Participants |
| Control | Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years | post-intervention | Highly concern | 3 Participants |
| Control | Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years | Baseline | Not answer | 0 Participants |
| Control | Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years | Baseline | No or low concern | 23 Participants |
| Control | Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years | Baseline | Somewhat concern | 11 Participants |
| Control | Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years | Baseline | Highly concern | 5 Participants |
Degree of Concern of CVD Event in Lifetime
Self-report survey question on Cardiovascular disease (CVD) awareness: degree of concern of CVD event in lifetime
Time frame: Three months
Population: Chi-square
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Text Messaging | Degree of Concern of CVD Event in Lifetime | Baseline | Somewhat concern | 15 Participants |
| Text Messaging | Degree of Concern of CVD Event in Lifetime | Baseline | highly concern | 8 Participants |
| Text Messaging | Degree of Concern of CVD Event in Lifetime | post-intervention | Somewhat concern | 14 Participants |
| Text Messaging | Degree of Concern of CVD Event in Lifetime | Baseline | Not answer | 0 Participants |
| Text Messaging | Degree of Concern of CVD Event in Lifetime | post-intervention | No concern/low concern | 12 Participants |
| Text Messaging | Degree of Concern of CVD Event in Lifetime | post-intervention | highly concern | 9 Participants |
| Text Messaging | Degree of Concern of CVD Event in Lifetime | post-intervention | Not answer | 5 Participants |
| Text Messaging | Degree of Concern of CVD Event in Lifetime | Baseline | No concern/low concern | 17 Participants |
| Control | Degree of Concern of CVD Event in Lifetime | post-intervention | Not answer | 4 Participants |
| Control | Degree of Concern of CVD Event in Lifetime | Baseline | No concern/low concern | 12 Participants |
| Control | Degree of Concern of CVD Event in Lifetime | post-intervention | No concern/low concern | 13 Participants |
| Control | Degree of Concern of CVD Event in Lifetime | post-intervention | Somewhat concern | 13 Participants |
| Control | Degree of Concern of CVD Event in Lifetime | Baseline | Somewhat concern | 20 Participants |
| Control | Degree of Concern of CVD Event in Lifetime | Baseline | highly concern | 7 Participants |
| Control | Degree of Concern of CVD Event in Lifetime | Baseline | Not answer | 0 Participants |
| Control | Degree of Concern of CVD Event in Lifetime | post-intervention | highly concern | 9 Participants |
Frequency of Concern of CVD Event
Self-report question to measure a patient's cardiovascular disease awareness: Frequency of concern of CVD event
Time frame: Three months
Population: Chi-square
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Text Messaging | Frequency of Concern of CVD Event | post-intervention | Never/rare concern | 24 Participants |
| Text Messaging | Frequency of Concern of CVD Event | post-intervention | Sometimes concern | 7 Participants |
| Text Messaging | Frequency of Concern of CVD Event | Baseline | Never/rare concern | 28 Participants |
| Text Messaging | Frequency of Concern of CVD Event | Baseline | Sometimes concern | 9 Participants |
| Text Messaging | Frequency of Concern of CVD Event | Baseline | Always concern | 3 Participants |
| Text Messaging | Frequency of Concern of CVD Event | Baseline | Not answer | 0 Participants |
| Text Messaging | Frequency of Concern of CVD Event | post-intervention | Always concern | 4 Participants |
| Text Messaging | Frequency of Concern of CVD Event | post-intervention | Not answer | 5 Participants |
| Control | Frequency of Concern of CVD Event | post-intervention | Not answer | 4 Participants |
| Control | Frequency of Concern of CVD Event | post-intervention | Never/rare concern | 29 Participants |
| Control | Frequency of Concern of CVD Event | Baseline | Always concern | 3 Participants |
| Control | Frequency of Concern of CVD Event | post-intervention | Sometimes concern | 5 Participants |
| Control | Frequency of Concern of CVD Event | post-intervention | Always concern | 1 Participants |
| Control | Frequency of Concern of CVD Event | Baseline | Never/rare concern | 26 Participants |
| Control | Frequency of Concern of CVD Event | Baseline | Not answer | 0 Participants |
| Control | Frequency of Concern of CVD Event | Baseline | Sometimes concern | 10 Participants |
Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity
A Self-report physical activity measure over the past month. The activities were converted to metabolic equivalent (MET: a measure of exercise intensity based on oxygen consumption) minutes per week for moderate/vigorous physical activity
Time frame: Three months
Population: Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Text Messaging | Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity | Baseline | 2112 MET minutes/week | Standard Error 1451 |
| Text Messaging | Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity | post-intervention | 3163 MET minutes/week | Standard Error 1555 |
| Control | Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity | Baseline | 1042 MET minutes/week | Standard Error 1430 |
| Control | Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity | post-intervention | 405 MET minutes/week | Standard Error 1532 |
Self-report Hemoglobin A1C
Self-report hemoglobin for diabetes status
Time frame: Three months
Population: Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Text Messaging | Self-report Hemoglobin A1C | Baseline | 7.9 percentage of glycated HB in blood | Standard Error 0.3 |
| Text Messaging | Self-report Hemoglobin A1C | post-intervention | 7.6 percentage of glycated HB in blood | Standard Error 0.3 |
| Control | Self-report Hemoglobin A1C | Baseline | 8.5 percentage of glycated HB in blood | Standard Error 0.3 |
| Control | Self-report Hemoglobin A1C | post-intervention | 8.0 percentage of glycated HB in blood | Standard Error 0.3 |
Total Carbohydrate
A self-report food frequency questionnaire over the past month
Time frame: One month
Population: Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Text Messaging | Total Carbohydrate | Baseline | 126 gram/day | Standard Error 10 |
| Text Messaging | Total Carbohydrate | post-intervention | 102 gram/day | Standard Error 11 |
| Control | Total Carbohydrate | Baseline | 111 gram/day | Standard Error 10 |
| Control | Total Carbohydrate | post-intervention | 100 gram/day | Standard Error 11 |