NCT03039569

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

February 28, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 3, 2019

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

1.3 years

First QC Date

January 24, 2017

Results QC Date

August 27, 2018

Last Update Submit

June 7, 2019

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes patientsDiabetes self-managementCardiovascular diseases awarenessHome food environmentText message

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • Self-care Activity: Medication Adherence

    Self-report survey question (days over the last seven days)

    three months

  • Self-care Activity: Foot Care

    Average of four self-report survey questions of the category (days over the last seven days)

    three months

  • Eat >= 5 Servings Fruit and Vegetables

    Self report survey question (days/week)

    Three months

Secondary Outcomes (6)

  • Self-report Hemoglobin A1C

    Three months

  • Frequency of Concern of CVD Event

    Three months

  • Total Carbohydrate

    One month

  • Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity

    Three months

  • Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years

    Three months

  • +1 more secondary outcomes

Study Arms (2)

Text messaging

EXPERIMENTAL

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

Behavioral: Text messaging

Control

NO INTERVENTION

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

Interventions

Text messagingBEHAVIORAL

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

Text messaging

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska-Lincoln (with Methodist Hospital System)

Lincoln, Nebraska, 68583-0806, United States

Location

Related Publications (5)

  • 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.

    PMID: 20067953BACKGROUND

  • 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.

    PMID: 11794490BACKGROUND

  • 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.

    PMID: 10895844BACKGROUND

  • 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.

    PMID: 23497632BACKGROUND

  • 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.

    PMID: 31212683DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

1\) The non-randomized, quasi-experimental study design; 2) Using self-report measures

Results Point of Contact

Title
Weiwen Chai
Organization
University of Nebraska-Lincoln
wchai2@unl.edu
402-472-7822

Study Officials

  • Weiwen Chai, PhD

    University of Nebraska Lincoln

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2017

First Posted

February 1, 2017

Study Start

February 28, 2017

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

June 19, 2019

Results First Posted

June 3, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)