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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text messaging
Sponsored by
University of Nebraska Lincoln
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 diabetes patients, Diabetes self-management, Cardiovascular diseases awareness, Home food environment, Text message

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Nebraska-Lincoln (with Methodist Hospital System)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Text messaging

Control

Arm Description

Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).

Participants will not receive text message intervention. This is the measurement-only group

Outcomes

Primary Outcome Measures

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)
Diabetes Self-care Activity: Exercise
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
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
Self-report survey question (days over the last seven days)
Self-care Activity: Foot Care
Average of four self-report survey questions of the category (days over the last seven days)
Eat >= 5 Servings Fruit and Vegetables
Self report survey question (days/week)

Secondary Outcome Measures

Self-report Hemoglobin A1C
Self-report hemoglobin for diabetes status
Frequency of Concern of CVD Event
Self-report question to measure a patient's cardiovascular disease awareness: Frequency of concern of CVD event
Total Carbohydrate
A self-report food frequency questionnaire over the past month
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
Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years
Self report survey question
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

Full Information

First Posted
January 24, 2017
Last Updated
June 7, 2019
Sponsor
University of Nebraska Lincoln
Collaborators
The Methodist Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03039569
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 28, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska Lincoln
Collaborators
The Methodist Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Type 2 diabetes patients, Diabetes self-management, Cardiovascular diseases awareness, Home food environment, Text message

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text messaging
Arm Type
Experimental
Arm Description
Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will not receive text message intervention. This is the measurement-only group
Intervention Type
Behavioral
Intervention Name(s)
Text messaging
Intervention Description
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
Primary Outcome Measure Information:
Title
Self-Care Activities: Healthy Eating
Description
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
Title
Diabetes Self-care Activity: Exercise
Description
Average of two self-report survey questions related to exercise in the category (days/over the last 7 days)
Time Frame
Three months
Title
Self-care Activity: Blood Glucose Testing
Description
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
Title
Self-care Activity: Medication Adherence
Description
Self-report survey question (days over the last seven days)
Time Frame
three months
Title
Self-care Activity: Foot Care
Description
Average of four self-report survey questions of the category (days over the last seven days)
Time Frame
three months
Title
Eat >= 5 Servings Fruit and Vegetables
Description
Self report survey question (days/week)
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Self-report Hemoglobin A1C
Description
Self-report hemoglobin for diabetes status
Time Frame
Three months
Title
Frequency of Concern of CVD Event
Description
Self-report question to measure a patient's cardiovascular disease awareness: Frequency of concern of CVD event
Time Frame
Three months
Title
Total Carbohydrate
Description
A self-report food frequency questionnaire over the past month
Time Frame
One month
Title
Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity
Description
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
Title
Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years
Description
Self report survey question
Time Frame
Three months
Title
Degree of Concern of CVD Event in Lifetime
Description
Self-report survey question on Cardiovascular disease (CVD) awareness: degree of concern of CVD event in lifetime
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiwen Chai, PhD
Organizational Affiliation
University of Nebraska Lincoln
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska-Lincoln (with Methodist Hospital System)
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68583-0806
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20067953
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.
Results Reference
background
PubMed Identifier
11794490
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.
Results Reference
background
PubMed Identifier
10895844
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.
Results Reference
background
PubMed Identifier
23497632
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.
Results Reference
background
PubMed Identifier
31212683
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.
Results Reference
derived

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

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