Clinical trial NCT03039569: Assessing Home Food Environment and Diabetes Self-management Among Adult Type 2 Diabetes Patients
Official title: Assessing Home Food Environment and Diabetes Self-management Among Adult Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes patients
Diabetes self-management
Cardiovascular diseases awareness
Home food environment
Text message
Lead sponsor: University of Nebraska Lincoln
Sponsor class: OTHER
Collaborators: name: The Methodist Hospital Research Institute
First posted: 2017-02-01
Enrollment: 79
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Self-Care Activities: Healthy Eating
timeFrame: Three months
measure: Diabetes Self-care Activity: Exercise
timeFrame: Three months
measure: Self-care Activity: Blood Glucose Testing
timeFrame: three months
measure: Self-care Activity: Medication Adherence
timeFrame: three months
measure: Self-care Activity: Foot Care
timeFrame: three months
measure: Eat >= 5 Servings Fruit and Vegetables
timeFrame: Three months
Secondary outcomes:
measure: Self-report Hemoglobin A1C
timeFrame: Three months
measure: Frequency of Concern of CVD Event
timeFrame: Three months
measure: Total Carbohydrate
timeFrame: One month
measure: Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity
timeFrame: Three months
measure: Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years
timeFrame: Three months
measure: Degree of Concern of CVD Event in Lifetime
timeFrame: Three months
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: University of Nebraska-Lincoln (with Methodist Hospital System)
state: Nebraska
Study officials:
affiliation: University of Nebraska Lincoln
name: Weiwen Chai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cowie CC, Rust KF, Byrd-Holt DD, Gregg EW, Ford ES, Geiss LS, Bainbridge KE, Fradkin JE. Prevalence of diabetes and high risk for diabetes using A1C criteria in the U.S. population in 1988-2006. Diabetes Care. 2010 Mar;33(3):562-8. doi: 10.2337/dc09-1524. Epub 2010 Jan 12.
citation: American Diabetes Association Task Force for Writing Nutrition Principles and Recommendations for the Management of Diabetes and Related Complications. American Diabetes Association position statement: evidence-based nutrition principles and recommendations for the treatment and prevention of diabetes and related complications. J Am Diet Assoc. 2002 Jan;102(1):109-18. doi: 10.1016/s0002-8223(02)90031-3.
citation: Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. doi: 10.2337/diacare.23.7.943.
citation: Goodarzi M, Ebrahimzadeh I, Rabi A, Saedipoor B, Jafarabadi MA. Impact of distance education via mobile phone text messaging on knowledge, attitude, practice and self efficacy of patients with type 2 diabetes mellitus in Iran. J Diabetes Metab Disord. 2012 Aug 31;11(1):10. doi: 10.1186/2251-6581-11-10.
citation: Nepper MJ, McAtee JR, Wheeler L, Chai W. Mobile Phone Text Message Intervention on Diabetes Self-Care Activities, Cardiovascular Disease Risk Awareness, and Food Choices among Type 2 Diabetes Patients. Nutrients. 2019 Jun 11;11(6):1314. doi: 10.3390/nu11061314.