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Evaluation of Exercise Application Technology in Adolescents

Primary Purpose

Type 2 Diabetes, PreDiabetes, Obesity

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
continuous glucose monitor (Freestyle Libre
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria for Type 2 diabetes arm BMI > 95th percentile A1c> 6.5% Age 14-17 (2 years post-menarchal) Inclusion for Prediabetes Arm Age 14-17 (2 years post-menarchal) A1c 5.7-6.4% Inclusion for Obesity Arm Age 14-17 (2 years post-menarchal) A1c 5.7-6.4% Exclusion Criteria for all arms BMI <95th percentile Specific obesity syndrome Inability to participate in exercise workouts

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    No Intervention

    Experimental

    No Intervention

    Experimental

    No Intervention

    Arm Label

    Obese, receives access to exercise phone application

    Obese, no intervention

    Prediabetes, receives access to exercise phone application

    Prediabetes, no intervention

    Type 2 diabetes, receives access to exercise phone application

    Type 2 diabetes, no intervention

    Arm Description

    obese, receives access to exercise phone application and interval contact by health provider in between clinic visits , receives continuous glucose monitor

    obese, receives continuous glucose monitor

    prediabetes receives access to exercise phone application and interval contact by health provider in between clinic visit, receives continuous glucose monitor

    prediabetes, receives continuous glucose monitor

    prediabetes receives access to exercise phone application and interval contact by health provider in between clinic visit, receives continuous glucose monitor

    Type 2 diabetes, receives continuous glucose monitor

    Outcomes

    Primary Outcome Measures

    skin fold thickness
    reliable estimate of subcutaneous fat at various sites of the body
    skin fold measurement
    reliable estimate of subcutaneous fat at various sites of the body
    skin fold measurement
    reliable estimate of subcutaneous fat at various sites of the body
    Body mass index
    measure of body fat based on height and weight
    Body mass index
    measure of body fat based on height and weight
    Body Mass Index
    measure of body fat based on height and weight

    Secondary Outcome Measures

    TNF-alpha
    inflammatory marker in the blood
    TNF-alpha
    inflammatory marker in the blood
    TNF-alpha
    inflammatory marker in the blood
    IL-6
    inflammatory marker in the blood
    IL-6
    inflammatory marker in the blood
    IL-6
    inflammatory marker in the blood

    Full Information

    First Posted
    January 31, 2023
    Last Updated
    April 14, 2023
    Sponsor
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05720377
    Brief Title
    Evaluation of Exercise Application Technology in Adolescents
    Official Title
    Evaluation of Exercise Application Technology and Continuous Glucose Monitoring to Improve Weight Loss and Metabolic Markers in Adolescents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Funding not obtained
    Study Start Date
    February 1, 2024 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    The purpose of the study is to evaluate the use of an exercise phone application and a continuous glucose monitor and their impact on metabolic disease in adolescents with obesity, prediabetes and Type 2 diabetes. Participants will be asked to wear a continuous glucose monitor (Freestyle Libre) and if they are in the intervention group also participate in using an exercise phone application as well as have scheduled interval contact with a health professional in between scheduled clinic visits to assess how they are reaching their goals.
    Detailed Description
    Patients will be recruited directly from the Childrens of Alabama pediatric endocrine clinic. Thirty patients who have obesity, prediabetes or Type 2 diabetes will be enrolled. During the enrollment phase, flyers will be posted in clinic and emails will be distributed to potential participants. Our study team will approach interested participants during their routine clinic visit. Consent will be obtained by study team during their endocrine clinic visit. Review of their medical records will be done and age, gender and race will be extracted from the medical record. A baseline visit with vital signs, blood work, a physical exam and nutritional counseling will be completed. Once enrolled, the patients will then be randomized.Within this pilot trial, we will randomize 15 adolescents/teenagers who either have obesity, prediabetes or Type 2 diabetes, to access to an exercise regimen and 15 adolescents to control intervention using a permuted block randomization scheme. The randomization scheme will contain 6 blocks of size 5 allowing for 30 randomized in the group with obesity, prediabetes and Type 2 diabetes. Those who are in the intervention group will then be given access to frequent telephone counseling to follow-up their nutrition and exercise goals, access to exercise application and accelerometer as described below. Follow-up will then be completed at 3 and 6 months with a physical exam, vital signs, blood draw. Intervention Group Access provided to exercise application Provided with Fitbit to wear and measure activity Weekly check-in with provider to determine how exercise goals have been that week. If unable to reach, we will text securely a clinic check-in and provide a healthy tip of the week. Meeting with nutrition at Baseline visit Continuous glucose monitor provided (plan to wear for 14 days during each month) Non-Intervention Group Meeting with nutrition at Baseline visit Continuous glucose monitor provided (plan to wear for 14 days at baseline visit, 3 month visit and 6 month visit)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes, PreDiabetes, Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    longitudinal
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Obese, receives access to exercise phone application
    Arm Type
    Experimental
    Arm Description
    obese, receives access to exercise phone application and interval contact by health provider in between clinic visits , receives continuous glucose monitor
    Arm Title
    Obese, no intervention
    Arm Type
    No Intervention
    Arm Description
    obese, receives continuous glucose monitor
    Arm Title
    Prediabetes, receives access to exercise phone application
    Arm Type
    Experimental
    Arm Description
    prediabetes receives access to exercise phone application and interval contact by health provider in between clinic visit, receives continuous glucose monitor
    Arm Title
    Prediabetes, no intervention
    Arm Type
    No Intervention
    Arm Description
    prediabetes, receives continuous glucose monitor
    Arm Title
    Type 2 diabetes, receives access to exercise phone application
    Arm Type
    Experimental
    Arm Description
    prediabetes receives access to exercise phone application and interval contact by health provider in between clinic visit, receives continuous glucose monitor
    Arm Title
    Type 2 diabetes, no intervention
    Arm Type
    No Intervention
    Arm Description
    Type 2 diabetes, receives continuous glucose monitor
    Intervention Type
    Device
    Intervention Name(s)
    continuous glucose monitor (Freestyle Libre
    Other Intervention Name(s)
    Contact by health care provider
    Intervention Description
    15 minute phone interview by health care provider to assess health goals set at clinic visits.
    Primary Outcome Measure Information:
    Title
    skin fold thickness
    Description
    reliable estimate of subcutaneous fat at various sites of the body
    Time Frame
    baseline
    Title
    skin fold measurement
    Description
    reliable estimate of subcutaneous fat at various sites of the body
    Time Frame
    3 month
    Title
    skin fold measurement
    Description
    reliable estimate of subcutaneous fat at various sites of the body
    Time Frame
    6 month
    Title
    Body mass index
    Description
    measure of body fat based on height and weight
    Time Frame
    baseline
    Title
    Body mass index
    Description
    measure of body fat based on height and weight
    Time Frame
    3 month
    Title
    Body Mass Index
    Description
    measure of body fat based on height and weight
    Time Frame
    6 month
    Secondary Outcome Measure Information:
    Title
    TNF-alpha
    Description
    inflammatory marker in the blood
    Time Frame
    baseline
    Title
    TNF-alpha
    Description
    inflammatory marker in the blood
    Time Frame
    3 months
    Title
    TNF-alpha
    Description
    inflammatory marker in the blood
    Time Frame
    6 months
    Title
    IL-6
    Description
    inflammatory marker in the blood
    Time Frame
    Baseline
    Title
    IL-6
    Description
    inflammatory marker in the blood
    Time Frame
    3 months
    Title
    IL-6
    Description
    inflammatory marker in the blood
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria for Type 2 diabetes arm BMI > 95th percentile A1c> 6.5% Age 14-17 (2 years post-menarchal) Inclusion for Prediabetes Arm Age 14-17 (2 years post-menarchal) A1c 5.7-6.4% Inclusion for Obesity Arm Age 14-17 (2 years post-menarchal) A1c 5.7-6.4% Exclusion Criteria for all arms BMI <95th percentile Specific obesity syndrome Inability to participate in exercise workouts

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

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    Evaluation of Exercise Application Technology in Adolescents

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