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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039569
• Other study ID #: 16200
• Status: Completed
• Phase: N/A
• Start date: February 28, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: June 2019
• Source: University of Nebraska Lincoln
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Text 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

Locations

Country	Name	City	State
United States	University of Nebraska-Lincoln (with Methodist Hospital System)	Lincoln	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska Lincoln	The Methodist Hospital System

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	Three months
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)	Three months
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)	three months
Primary	Self-care Activity: Medication Adherence	Self-report survey question (days over the last seven days)	three months
Primary	Self-care Activity: Foot Care	Average of four self-report survey questions of the category (days over the last seven days)	three months
Primary	Eat >= 5 Servings Fruit and Vegetables	Self report survey question (days/week)	Three months
Secondary	Self-report Hemoglobin A1C	Self-report hemoglobin for diabetes status	Three months
Secondary	Frequency of Concern of CVD Event	Self-report question to measure a patient's cardiovascular disease awareness: Frequency of concern of CVD event	Three months
Secondary	Total Carbohydrate	A self-report food frequency questionnaire over the past month	One month
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	Three months
Secondary	Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years	Self report survey question	Three months
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	Three months