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Assessing Home Food Environment and Diabetes Self-management Among Adult Type 2 Diabetes Patients

Assessing Home Food Environment and Diabetes Self-management Among Adult Type 2 Diabetes Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03039569
Enrollment
79
Registered
2017-02-01
Start date
2017-02-28
Completion date
2018-05-31
Last updated
2019-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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

BEHAVIORALText messaging

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

The Methodist Hospital Research Institute
CollaboratorOTHER
University of Nebraska Lincoln
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Eat >= 5 Servings Fruit and VegetablesThree monthsSelf report survey question (days/week)
Self-Care Activities: Healthy EatingThree monthsAn 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: ExerciseThree monthsAverage of two self-report survey questions related to exercise in the category (days/over the last 7 days)
Self-care Activity: Blood Glucose Testingthree monthsAverage 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 Adherencethree monthsSelf-report survey question (days over the last seven days)
Self-care Activity: Foot Carethree monthsAverage of four self-report survey questions of the category (days over the last seven days)

Secondary

MeasureTime frameDescription
Self-report Hemoglobin A1CThree monthsSelf-report hemoglobin for diabetes status
Frequency of Concern of CVD EventThree monthsSelf-report question to measure a patient's cardiovascular disease awareness: Frequency of concern of CVD event
Total CarbohydrateOne monthA self-report food frequency questionnaire over the past month
Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical ActivityThree monthsA 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 YearsThree monthsSelf report survey question
Degree of Concern of CVD Event in LifetimeThree monthsSelf-report survey question on Cardiovascular disease (CVD) awareness: degree of concern of CVD event in lifetime

Countries

United States

Participant flow

Participants by arm

ArmCount
Text Messaging
Intervention group received three text messages per week for 12 weeks
40
Control
Control group did not receive text messages
39
Total79

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up54

Baseline characteristics

CharacteristicText MessagingControlTotal
Age, Customized58.8 years
STANDARD_DEVIATION 10.6
55.7 years
STANDARD_DEVIATION 12.2
56.9 years
STANDARD_DEVIATION 11.4
Race/Ethnicity, Customized
Asian
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Black
1 Participants2 Participants3 Participants
Race/Ethnicity, Customized
Hispanic
3 Participants0 Participants3 Participants
Race/Ethnicity, Customized
other
2 Participants1 Participants3 Participants
Race/Ethnicity, Customized
White
33 Participants36 Participants69 Participants
Region of Enrollment
United States
40 Participants39 Participants79 Participants
Sex: Female, Male
Female
26 Participants26 Participants52 Participants
Sex: Female, Male
Male
14 Participants13 Participants27 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 400 / 39
other
Total, other adverse events
0 / 400 / 39
serious
Total, serious adverse events
0 / 400 / 39

Outcome results

Primary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Text MessagingDiabetes Self-care Activity: ExerciseBaseline5.13 days/week (min: 0 days; Max: 7 days)Standard Error 0.62
Text MessagingDiabetes Self-care Activity: Exercisepost-intervention4.48 days/week (min: 0 days; Max: 7 days)Standard Error 0.66
ControlDiabetes Self-care Activity: ExerciseBaseline4.91 days/week (min: 0 days; Max: 7 days)Standard Error 0.66
ControlDiabetes Self-care Activity: Exercisepost-intervention4.25 days/week (min: 0 days; Max: 7 days)Standard Error 0.69
Primary

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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Text MessagingEat >= 5 Servings Fruit and Vegetables4.1 day/week (min: 0 days; max 7 days)Standard Error 0.4
ControlEat >= 5 Servings Fruit and Vegetables4.0 day/week (min: 0 days; max 7 days)Standard Error 0.3
Primary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Text MessagingSelf-Care Activities: Healthy EatingBaseline4.23 days/week (min: 0 days; Max: 7 days)Standard Error 0.38
Text MessagingSelf-Care Activities: Healthy Eatingpost-intervention4.61 days/week (min: 0 days; Max: 7 days)Standard Error 0.4
ControlSelf-Care Activities: Healthy EatingBaseline4.67 days/week (min: 0 days; Max: 7 days)Standard Error 0.4
ControlSelf-Care Activities: Healthy Eatingpost-intervention4.60 days/week (min: 0 days; Max: 7 days)Standard Error 0.41
Primary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Text MessagingSelf-care Activity: Blood Glucose TestingBaseline5.09 days/ week (min: 0 days; max: 7 days))Standard Error 0.64
Text MessagingSelf-care Activity: Blood Glucose Testingpost-intervention5.27 days/ week (min: 0 days; max: 7 days))Standard Error 0.68
ControlSelf-care Activity: Blood Glucose TestingBaseline5.93 days/ week (min: 0 days; max: 7 days))Standard Error 0.69
ControlSelf-care Activity: Blood Glucose Testingpost-intervention5.63 days/ week (min: 0 days; max: 7 days))Standard Error 0.7
Primary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Text MessagingSelf-care Activity: Foot CareBaseline4.17 day/week (min: 0 days; max 7 days)Standard Error 0.41
Text MessagingSelf-care Activity: Foot Carepost-intervention4.89 day/week (min: 0 days; max 7 days)Standard Error 0.44
ControlSelf-care Activity: Foot CareBaseline4.22 day/week (min: 0 days; max 7 days)Standard Error 0.45
ControlSelf-care Activity: Foot Carepost-intervention4.18 day/week (min: 0 days; max 7 days)Standard Error 0.45
Primary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Text MessagingSelf-care Activity: Medication AdherenceBaseline5.75 day/week (min: 0 days; max 7 days)Standard Error 0.22
Text MessagingSelf-care Activity: Medication Adherencepost-intervention5.73 day/week (min: 0 days; max 7 days)Standard Error 0.23
ControlSelf-care Activity: Medication AdherenceBaseline5.83 day/week (min: 0 days; max 7 days)Standard Error 0.23
ControlSelf-care Activity: Medication Adherencepost-intervention5.67 day/week (min: 0 days; max 7 days)Standard Error 0.24
Secondary

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

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Text MessagingAwareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Yearspost-interventionNo or low concern19 Participants
Text MessagingAwareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 YearsBaselineNo or low concern24 Participants
Text MessagingAwareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Yearspost-interventionHighly concern5 Participants
Text MessagingAwareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 YearsBaselineSomewhat concern13 Participants
Text MessagingAwareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Yearspost-interventionSomewhat concern11 Participants
Text MessagingAwareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 YearsBaselineHighly concern3 Participants
Text MessagingAwareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Yearspost-interventionNot answer5 Participants
Text MessagingAwareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 YearsBaselineNot answer0 Participants
ControlAwareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Yearspost-interventionNot answer4 Participants
ControlAwareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Yearspost-interventionNo or low concern24 Participants
ControlAwareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Yearspost-interventionSomewhat concern8 Participants
ControlAwareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Yearspost-interventionHighly concern3 Participants
ControlAwareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 YearsBaselineNot answer0 Participants
ControlAwareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 YearsBaselineNo or low concern23 Participants
ControlAwareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 YearsBaselineSomewhat concern11 Participants
ControlAwareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 YearsBaselineHighly concern5 Participants
Secondary

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

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Text MessagingDegree of Concern of CVD Event in LifetimeBaselineSomewhat concern15 Participants
Text MessagingDegree of Concern of CVD Event in LifetimeBaselinehighly concern8 Participants
Text MessagingDegree of Concern of CVD Event in Lifetimepost-interventionSomewhat concern14 Participants
Text MessagingDegree of Concern of CVD Event in LifetimeBaselineNot answer0 Participants
Text MessagingDegree of Concern of CVD Event in Lifetimepost-interventionNo concern/low concern12 Participants
Text MessagingDegree of Concern of CVD Event in Lifetimepost-interventionhighly concern9 Participants
Text MessagingDegree of Concern of CVD Event in Lifetimepost-interventionNot answer5 Participants
Text MessagingDegree of Concern of CVD Event in LifetimeBaselineNo concern/low concern17 Participants
ControlDegree of Concern of CVD Event in Lifetimepost-interventionNot answer4 Participants
ControlDegree of Concern of CVD Event in LifetimeBaselineNo concern/low concern12 Participants
ControlDegree of Concern of CVD Event in Lifetimepost-interventionNo concern/low concern13 Participants
ControlDegree of Concern of CVD Event in Lifetimepost-interventionSomewhat concern13 Participants
ControlDegree of Concern of CVD Event in LifetimeBaselineSomewhat concern20 Participants
ControlDegree of Concern of CVD Event in LifetimeBaselinehighly concern7 Participants
ControlDegree of Concern of CVD Event in LifetimeBaselineNot answer0 Participants
ControlDegree of Concern of CVD Event in Lifetimepost-interventionhighly concern9 Participants
Secondary

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

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Text MessagingFrequency of Concern of CVD Eventpost-interventionNever/rare concern24 Participants
Text MessagingFrequency of Concern of CVD Eventpost-interventionSometimes concern7 Participants
Text MessagingFrequency of Concern of CVD EventBaselineNever/rare concern28 Participants
Text MessagingFrequency of Concern of CVD EventBaselineSometimes concern9 Participants
Text MessagingFrequency of Concern of CVD EventBaselineAlways concern3 Participants
Text MessagingFrequency of Concern of CVD EventBaselineNot answer0 Participants
Text MessagingFrequency of Concern of CVD Eventpost-interventionAlways concern4 Participants
Text MessagingFrequency of Concern of CVD Eventpost-interventionNot answer5 Participants
ControlFrequency of Concern of CVD Eventpost-interventionNot answer4 Participants
ControlFrequency of Concern of CVD Eventpost-interventionNever/rare concern29 Participants
ControlFrequency of Concern of CVD EventBaselineAlways concern3 Participants
ControlFrequency of Concern of CVD Eventpost-interventionSometimes concern5 Participants
ControlFrequency of Concern of CVD Eventpost-interventionAlways concern1 Participants
ControlFrequency of Concern of CVD EventBaselineNever/rare concern26 Participants
ControlFrequency of Concern of CVD EventBaselineNot answer0 Participants
ControlFrequency of Concern of CVD EventBaselineSometimes concern10 Participants
Secondary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Text MessagingMetabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical ActivityBaseline2112 MET minutes/weekStandard Error 1451
Text MessagingMetabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activitypost-intervention3163 MET minutes/weekStandard Error 1555
ControlMetabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical ActivityBaseline1042 MET minutes/weekStandard Error 1430
ControlMetabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activitypost-intervention405 MET minutes/weekStandard Error 1532
Secondary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Text MessagingSelf-report Hemoglobin A1CBaseline7.9 percentage of glycated HB in bloodStandard Error 0.3
Text MessagingSelf-report Hemoglobin A1Cpost-intervention7.6 percentage of glycated HB in bloodStandard Error 0.3
ControlSelf-report Hemoglobin A1CBaseline8.5 percentage of glycated HB in bloodStandard Error 0.3
ControlSelf-report Hemoglobin A1Cpost-intervention8.0 percentage of glycated HB in bloodStandard Error 0.3
Secondary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Text MessagingTotal CarbohydrateBaseline126 gram/dayStandard Error 10
Text MessagingTotal Carbohydratepost-intervention102 gram/dayStandard Error 11
ControlTotal CarbohydrateBaseline111 gram/dayStandard Error 10
ControlTotal Carbohydratepost-intervention100 gram/dayStandard Error 11

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026