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

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ClinicalTrials.gov Identifier: NCT03039569
Recruitment Status : Completed
First Posted : February 1, 2017
Results First Posted : June 3, 2019
Last Update Posted : June 19, 2019
Sponsor:
Collaborator:
The Methodist Hospital Research Institute
Information provided by (Responsible Party):
University of Nebraska Lincoln

Tracking Information
First Submitted Date  ICMJE January 24, 2017
First Posted Date  ICMJE February 1, 2017
Results First Submitted Date  ICMJE August 27, 2018
Results First Posted Date  ICMJE June 3, 2019
Last Update Posted Date June 19, 2019
Actual Study Start Date  ICMJE February 28, 2017
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • Self-Care Activities: Healthy Eating [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: three months ]
    Self-report survey question (days over the last seven days)
  • Self-care Activity: Foot Care [ Time Frame: three months ]
    Average of four self-report survey questions of the category (days over the last seven days)
  • Eat >= 5 Servings Fruit and Vegetables [ Time Frame: Three months ]
    Self report survey question (days/week)
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
Diabetes Self-Care Activities Survey [ Time Frame: Three months ]
A self-report questionnaire about patient's diabetes self-care activities
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
  • Self-report Hemoglobin A1C [ Time Frame: Three months ]
    Self-report hemoglobin for diabetes status
  • Frequency of Concern of CVD Event [ Time Frame: Three months ]
    Self-report question to measure a patient's cardiovascular disease awareness: Frequency of concern of CVD event
  • Total Carbohydrate [ Time Frame: One month ]
    A self-report food frequency questionnaire over the past month
  • Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity [ Time Frame: 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 [ Time Frame: Three months ]
    Self report survey question
  • Degree of Concern of CVD Event in Lifetime [ Time Frame: Three months ]
    Self-report survey question on Cardiovascular disease (CVD) awareness: degree of concern of CVD event in lifetime
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
  • Self-report Hemoglobin A1C [ Time Frame: Three months ]
  • patient's cardiovascular diseases awareness questionnaire [ Time Frame: Three months ]
    A questionnaire to measure a patient's cardiovascular disease awareness
  • Home food environment survey questionnaire [ Time Frame: one day ]
    A survey questionnaire to measure the availability and visibility of home healthy and unhealthy foods and beverages
  • Quality of life questionnaire (SF-12 Health Survey) [ Time Frame: Three months ]
  • Block Food Frequency Questionnaire [ Time Frame: One month ]
    A self-report food frequency questionnaire over the past month
  • Block Physical Activity Survey [ Time Frame: one month ]
    A Self-report physical activity measure over the past month
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing Home Food Environment and Diabetes Self-management Among Adult Type 2 Diabetes Patients
Official Title  ICMJE Assessing Home Food Environment and Diabetes Self-management Among Adult Type 2 Diabetes Patients
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Text messaging
    Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).
    Intervention: Behavioral: Text messaging
  • No Intervention: Control
    Participants will not receive text message intervention. This is the measurement-only group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2019)
79
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2017)
100
Actual Study Completion Date  ICMJE May 31, 2018
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03039569
Other Study ID Numbers  ICMJE 16200
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Nebraska Lincoln
Study Sponsor  ICMJE University of Nebraska Lincoln
Collaborators  ICMJE The Methodist Hospital Research Institute
Investigators  ICMJE
Principal Investigator: Weiwen Chai, PhD University of Nebraska Lincoln
PRS Account University of Nebraska Lincoln
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP