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Completed

NCT Number: NCT02858648

Diabetes Go Mobile! Pilot Study

The purpose of this study is to examine whether a behavioral lifestyle intervention using mobile smart phone technology for self-monitoring can lead to greater improvements in diabetes outcomes.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

The investigators will conduct a pilot randomized controlled clinical trial to examine the feasibility and preliminary efficacy of a behavioral lifestyle intervention on weight, glycemic control, and vascular inflammatory marker outcomes. A total of 26 overweight or obese patients with type 2 diabetes will be recruited from an underserved minority community health center in Houston, TX. They were randomly assigned into one of the three groups: 1) Behavior intervention with smart phone based self-monitoring, 2) Behavior intervention with paper diary based self-monitoring, and 3) Usual care group. Both Mobile and Paper groups received a total of 11 group sessions and 1 individual session in a 6-month intervention. Mobile group received an android-based smart phone with two applications loaded to help them record their diet, physical activity, weight, and blood glucose, while the paper group is using paper diaries for these recordings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 21 to 74 years of age
  • BMI≥ 25 kg/m2
  • Self-reported being diagnosed with type 2 diabetes for at least 6 months
  • Currently monitor blood glucose and has a blood glucose meter
  • Be able to read and write in English

Exclusion criteria

  • Previously participated in a structured lifestyle intervention, such as Look AHEAD in the last 12 months
  • Current pregnant /nursing or plan to become pregnant in the next 6 months
  • In addition to their diabetes condition, presence of a current serious illness or unstable condition requiring supervision on a special diet and limiting their ability to perform physical activity level.
  • Current treatment for a severe psychological disorder
  • Planned vacation, absences, or relocation in the next 6 months

Treatment and study plan

Behavior intervention with smart phone based self-monitoring

Behavioral

Use two smartphone applications for self-monitoring of diet, physical activity, weight, and blood glucose (connected via a blue-tooth enabled glucometer), plus 11 group session and 1 individual session focused on behavioral strategies

Behavior intervention with paper diary based self-monitoring

Behavioral

Use paper diaries along with a calorie counter booklet, weight scale, food scale, and pedometer for self-monitoring of diet, physical activity, weight, and blood glucose, plus 11 group session and 1 individual session focused on behavioral strategies

Primary outcomes

  1. Change in Weight as assessed by the Tanita Scale

    Time frame: baseline, 3 months, 6 months

  2. Change in Glycemic control as assessed by HbA1c levels

    Time frame: baseline, 3 months, 6 months

Secondary outcomes

  1. Change in Dietary intake as measured by the Automated Self-administered 24-hour Dietary Recall (ASA24™) version 1

    Time frame: baseline, 3 months, 6 months

  2. Change in Physical Activity as assessed by accelerometer

    Time frame: baseline, 3 months, 6 months

  3. Change in Physical Activity as assessed by IPAQ-Short Form

    Time frame: baseline, 3 months, 6 months

  4. Change in Blood pressure as assessed by automated blood pressure cuff

    Time frame: baseline, 3 months, 6 months

  5. Change in Waist circumference

    Time frame: baseline, 3 months, 6 months

  6. Change in Inflammation as assessed by C-reactive protein levels

    Time frame: baseline, 3 months, 6 months

  7. Change in Inflammation as assessed by IL-6 levels

    Time frame: baseline, 3 months, 6 months

  8. Percent attendance at group sessions

    Time frame: 6 months

  9. Percent adherence to self-monitoring

    Time frame: 6 months

  10. Change in Health literacy as measured by the Newest Vital Sign health literacy assessment

    Time frame: baseline, 3 months, 6 months

  11. Change in Medication Adherence as assessed by the Morisky medication adherence questionnaire

    Time frame: baseline, 3 months, 6 months

  12. Change in Depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: baseline, 3 months, 6 months

  13. Change in Diabetes Self-Care as Assessed by the Summary of Diabetes Self-Care Activities Expanded Version

    Time frame: baseline, 3 months, 6 months

  14. Change in Quality of life as assessed by the PROMIS Global

    Time frame: baseline, 3 months, 6 months

  15. Change in Clinical utility as assessed by the PROMIS 57

    Time frame: baseline, 3 months, 6 months

  16. Change in Perceived Stress as measured by the Perceived Stress Scale

    Time frame: baseline, 3 months, 6 months

  17. Change in Sleep Quality as assessed by the Pittsburgh Sleep Quality Index

    Time frame: baseline, 3 months, 6 months

  18. Change in Sleepiness. Assessed by the Epworth Sleepiness Scale

    Time frame: baseline, 3 months, 6 months

  19. Change in Self-efficacy for diabetes as assessed by the Self-efficacy for diabetes measure

    Time frame: baseline, 3 months, 6 months

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Harris Health System

Registry information

Official study title

Diabetes Go Mobile! - A Pilot Study Testing the Effect of a Behavioral Intervention With Smart Phone Based Self-Monitoring on Glycemic Control and Vascular Inflammatory Markers

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 8, 2016
Registry last updated
Aug 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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