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Technology-delivered Physical Activity Program for Adolescents With Type 1 Diabetes (Activate)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05319600
Recruitment Status : Recruiting
First Posted : April 8, 2022
Last Update Posted : April 8, 2022
Sponsor:
Information provided by (Responsible Party):
Amy Hughes Lansing, University of Vermont

Brief Summary:
This project is comprised of a two-arm randomized control trial (RCT) testing the feasibility, acceptability, and preliminary efficacy of a nationally scalable program, Activate, a 12-week, technology-delivered diabetes behavior-change skills training and physical activity promotion program for adolescents with type 1 diabetes. The researchers have a recruitment goal of 30 participants, but will enroll beyond 30 to address any withdrawal and ensure sample size is met. A primary goal of the study is assessing the feasibility and acceptability of the program, which combines two previously piloted components. Then, the investigators will compare the 12-week Activate program to a treatment as usual control group on proximal outcomes of behavior-change skills and daily active minutes. The investigators will also explore the impact of the Activate program on secondary mechanisms and outcomes linked with later type 1 diabetes health disparities: adolescent diabetes behavior regulation, psychological distress, inflammation, glycemic outcomes, and cardiovascular disease risk. It is hypothesized that a diabetes behavior-change skills training and physical activity intervention will be acceptable, and effective at improving behavior-change skills and daily active minutes, as well as other mechanisms and outcomes linked with later type 1 diabetes health disparities.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: Diabetes behavior change skills training Behavioral: Physical activity promotion program Not Applicable

Detailed Description:

Adolescents with type 1 diabetes and socioeconomic disadvantage experience significant health disparities in glycemic outcomes in adolescence and cardiovascular disease and diabetes-related death later in adulthood. Socioeconomic disadvantage is associated with elevated glycosylated hemoglobin (HbA1c) and 3x risk of repeat hospitalizations for diabetic ketoacidosis as well as 2-3x risk of cardiovascular disease and diabetes-related death. Suboptimal glycemic outcomes are a powerful determinant of long-term health complications and costs, with a 1% reduction in HbA1c contributing to up to a 40% reduction in risk for later nephropathy, retinopathy, and macrovascular disease. Given the substantial health disparities for persons with type 1 diabetes and socioeconomic disadvantage and the many challenges that adolescents face with achieving optimal glycemic levels (<20% nationally meet American Diabetes Association HbA1c targets), this is a critical population to support in health behavior change via psychosocial intervention during adolescence. Unfortunately, existing evidence-based psychosocial type 1 diabetes interventions for adolescents, including robust multi-system approaches, have demonstrated limited efficacy for behavior change that results in improved glycemic outcomes and none have directly targeted cardiovascular health outside of glycemic outcomes. In this project, the researchers pursue a new avenue for intervention innovation by testing a nationally-scalable diabetes behavior-change skills training and physical activity intervention program to improve glycemic outcomes and decrease cardiovascular disease risks for adolescents with type 1 diabetes including those with socioeconomic disadvantage .

In this study the researchers will conduct a two-arm randomized trial with 30 adolescents with type 1 diabetes, comparing the 12-week Activate program to a treatment-as-usual control group. This study has 2 primary aims. First, the investigators will assess acceptability of the Activate program by examining participant engagement with the Activate program components. To assess the preliminary efficacy of the Activate program the investigators will examine changes in proximal outcomes of behavior-change skills (goal setting, problem-solving, and coping skills), and active minutes compared between treatment and control groups from baseline to a 12-week follow-up assessment. Second, the investigators will explore the impact of the Activate program on secondary mechanisms and outcomes linked with longer-term type 1 diabetes health disparities.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Adolescents (aged 13-17) diagnosed with type 1 diabetes will all complete a baseline assessment where they will be randomized to complete a 12-week physical activity and behavior-change skills training intervention, or to follow their usual diabetes care plan for 12 weeks. Both groups will receive a Garmin fitness activity tracker wrist watch to track their physical activity over the 12-week study period. Follow-up assessments for all participants will take place after 12 weeks.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does a Behavior Change Skills and Physical Activity Program Improve Self-regulation and Health Outcomes in Adolescents With Type 1 Diabetes?
Actual Study Start Date : March 23, 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
This arm will complete an intervention delivered remotely via an online website and online communication from the research team across the 12-week intervention period. This intervention has two parts, taking place simultaneously over the 12 weeks. First, participants will complete 8 web-delivered online behavior-change skills learning sessions which include reading and activities. Second, participants will be given daily and weekly personalized physical activity goals to meet, which will be tracked via their Garmin activity tracker and weekday text and if indicated video support. They have the opportunity to win money each week for meeting activity goals.
Behavioral: Diabetes behavior change skills training
Behavior-change skills training will be provided through eight web-delivered content and activity sessions across the 12-week program. Sessions 1 through 4 will occur weekly and sessions 5 through 8 biweekly. Each session takes approximately 15-20 minutes for the adolescent to complete both content learning and related activities. These learning sessions focus on skills like problem solving and goal setting.

Behavioral: Physical activity promotion program
The physical activity incentives program includes 12 weeks of personalized goals and incentives for increasing physically active minutes along with weekday text-based support. Active minutes, defined as minutes with moderate to vigorous physical activity, will be tracked via a Garmin fitness activity tracker.

No Intervention: Treatment as usual - Control
This arm will not complete an intervention. Participants will be instructed to wear a Garmin activity tracker but will be given no other specific instructions, other than to continue to follow their normal daily diabetes care plan.



Primary Outcome Measures :
  1. Change from Baseline in Coping Skills Assessed by the Coping Self-Efficacy Scale [ Time Frame: week 1 and week 12 ]
    Assesses adolescents' coping skill self-efficacy. Indexes participants confidence in using different strategies to cope with challenges in daily life. The Coping Self-Efficacy Scale includes 26-items rated on an 11-point scale (0 ('cannot do at all'), 5 ('moderately certain can do') and 10 ('certain can do')). Higher scores indicate higher coping self-efficacy.

  2. Change from Baseline in Goal Setting Assessed by Goal-Directed Planning [ Time Frame: week 1 and week 12 ]
    Participants will be asked to identify their most important diabetes, academic, social, and career/family goals. Following this, participants will be asked to identify which of their three non-diabetes goals most interfered with their diabetes goal. Participants will also complete the four-item planning subscale from the Goal System Assessment Battery to determine goal-directed planning activity for both their diabetes goal and their interfering goal identified in the goal assessment. The Goal System Assessment Battery is rated on a 5-point scale (1 = not at all true, 5 = extremely true). Higher scores indicated higher goal directed planning. Average levels of goal-directed planning will be used as the outcome variable for goal setting.

  3. Change from Baseline in Physical Activity [ Time Frame: daily for all days from week 1 through week 12 ]
    The Garmin fitness activity tracker tracking will be used to determine the average number of daily minutes with moderate to vigorous physical activity, metabolic equivalents (METs) greater than or equal to 3 METs.


Secondary Outcome Measures :
  1. Change from Baseline in Self-Regulation Assessed by The Functional Assessment of Maladaptive Behaviors [ Time Frame: week 1 and week 12 ]
    Assesses perceptions of the extent to which a person's behavior was sensitive to a particular reinforcer by rating 8 statements regarding the function of the behavior on a 4-point scale (0 = never, 3 = often). Higher scores indicate higher diabetes self-regulation.

  2. Change from Baseline in Self-Regulation Assessed by the Diabetes Habit Strength (DHS) Measure [ Time Frame: week 1 and week 12 ]
    Measures perceived habitual responding for glucose checking, insulin dosing, and carbohydrate counting and predicts daily treatment engagement in adolescents with type 1 diabetes. The Diabetes Habit Strength Measure includes 16 items on a 7-point scale (0 = strongly disagree, 7 = strongly agree). Higher scores indicate higher habit strength and thus higher self-regulation.

  3. Change from Baseline in Self-Regulation Assessed by the Self Care Inventory (SCI) [ Time Frame: week 1 and week 12 ]
    Measures diabetes treatment engagement. The Self Care Inventory includes 21 items about frequency of treatment engagement rated on a 5-point scale (0 = never, 5 = always). Higher scores indicate higher diabetes self care and thus higher self-regulation.

  4. Change from Baseline in Self-Regulation Assessed by the Effortful Control Scale Short [ Time Frame: week 1 and week 12 ]
    Measures challenges with self-regulation including inhibitory control, attention, and activation control. The Effortful Control Scale Short includes 16 items rated on a 5-point scale (1 = almost always untrue, 5 = almost always true). Higher scores indicate higher self-regulation.

  5. Change from Baseline in Self-Regulation Assessed by the Delay Discounting Task [ Time Frame: week 1 and week 12 ]
    Assesses preference for immediate over delayed rewards. The Delay Discounting Task includes 5 items. In each item participants will be asked if the'd prefer to receive $500 now or wait to receive $1000 after a specified delay in time.

  6. Change from Baseline in Diet and Physical Activity Habit Strength Assessed by the Eating and Activity Behavioral Automaticity Scale (EABA) [ Time Frame: week 1 and week 12 ]
    Measures perceived habitual responding for food and physical activity. The Eating and Activity Behavioral Automaticity Scale includes 14 items rated on a 7-point scale (1 = never, 7 = every time). Higher scores indicate higher diet and physical activity habit strength and thus higher self-regulation.

  7. Change from Baseline in Distress Assessed by the Patient Health Questionnaire for Adolescents (PHQ-A) [ Time Frame: week 1 and week 12 ]
    Measures how often participants have been bothered by specified symptoms of depression during the past two weeks. The Patient Health Questionnaire for Adolescents includes 8 items (excluding item 9 for suicidal ideation) rated on a 4-point scale (0 = not at all, 3 = nearly every day). Higher scores indicated higher distress.

  8. Change from Baseline in Distress Assessed by the Pediatric Symptom Checklist (PSC-17) [ Time Frame: week 1 and week 12 ]
    Indexes internalizing, externalizing, and attention symptoms in children. The Pediatric Symptom Checklist includes 17 items regarding the frequency of specified symptoms rated on a 3-point scale (never, sometimes, often). A score ≥ 15 indicates a positive symptom score and thus higher distress.

  9. Change from Baseline in Distress Assessed by the Motivation and Energy Inventory (MEI) [ Time Frame: week 1 and week 12 ]
    Measures the extent of diminished engagement in reward motivated cognition, physical behavior, and social interactions. The Motivation and Energy Inventory includes 26 items rated on various scales (5-point scale 0 = never, 5 = everyday or nearly every day; 6-point scale 0 = never, 6 = all of the time; 5-point scale 0 = never, 5 = at least 7 times a week; 4-point scale 0 = not interested at all, 4 = extremely interested) which measure mental energy, physical energy, and social motivation.

  10. Change from Baseline in Distress Assessed by the Perceived Stress Scale (PSS) [ Time Frame: week 1 and week 12 ]
    Measures perceived stress; asks participants have often they've had certain feelings or thoughts during the past month. The Perceived Stress Scale includes 10 items rated on a 5-point scale (0 = never, 4 = very often). Higher scores indicate higher perceived stress.

  11. Change from Baseline in Distress Assessed by the Diabetes Stress Questionnaire - Short Form (DSQ) [ Time Frame: week 1 and week 12 ]
    Measures how stressful, upsetting, difficult, or much of a problem specified diabetes-specific stressors are. The Diabetes Stress Questionnaire - Short Form includes 24 items rated on a 4-point scale (0 = not at all, 3 = very much). Higher scores indicate higher diabetes stress.

  12. Change from Baseline in Distress Assessed by the Type 1 Diabetes Quality of Life (T1DAL) Measure [ Time Frame: week 1 and week 12 ]
    Measures diabetes-related quality of life by asking how often specified statements regarding diabetes are true. The Type 1 Diabetes Quality of Life measure includes 23 items rated on a 5-point scale (0 = no, not at all true, 5 = yes, very true). Higher scores indicate higher diabetes quality of life and thus lower distress.

  13. Change from Baseline in Inflammation Assessed by C-Reactive Protein [ Time Frame: week 1 and week 12 ]
    C-reactive protein will be measured through dried blood spot assay.

  14. Change from Baseline in Glycosylated Hemoglobin (HbA1c) Percentage [ Time Frame: week 1 and week 12 ]
    Measured through dried blood spot assay.

  15. Change from Baseline in Mean Daily Blood Glucose (MBG) [ Time Frame: week 1 and week 12 ]
    Assessed by participant report from diabetes device data from glucose meters and continuous glucose monitors (CGMs). This will include data from the 7 days prior to the baseline assessment and 7 days prior to the follow-up assessment.

  16. Change from Baseline in Mean Variability in Blood Glucose [ Time Frame: week 1 and week 12 ]
    Assessed by participant report from diabetes device data from glucose meters and continuous glucose monitors (CGMs). This will include data from the 7 days prior to the baseline assessment and 7 days prior to the follow-up assessment.

  17. Change from Baseline in Cardiovascular Disease Risk Score Assessed by Weight [ Time Frame: week 1 and week 12 ]
    Assessed per the American Heart Association Life's Simple 7 index, which includes weight. Cardiovascular health risks will be summarized through a single risk score. For each risk indicator, meeting ideal, intermediate, or poor health status will be associated with a score of 2 to 0, respectively, creating a 0 to 14 scale of cardiovascular disease risk.

  18. Change from Baseline in Cardiovascular Disease Risk Score Assessed by Blood Pressure [ Time Frame: week 1 and week 12 ]
    Assessed per the American Heart Association Life's Simple 7 index, which includes blood pressure. Cardiovascular health risks will be summarized through a single risk score. For each risk indicator, meeting ideal, intermediate, or poor health status will be associated with a score of 2 to 0, respectively, creating a 0 to 14 scale of cardiovascular disease risk.

  19. Change from Baseline in Cardiovascular Disease Risk Score Assessed by Diet [ Time Frame: week 1 and week 12 ]
    Assessed per the American Heart Association Life's Simple 7 index, which includes diet. Adolescents will report on diet habit using the standardized healthy diet questions from that match the American Health Association Healthy diet recommendations (intake of sodium, whole grains, fruits, vegetables, sugar-sweetened beverages, and fish) and they will report if they've tried or currently smoke. Cardiovascular health risks will be summarized through a single risk score. For each risk indicator, meeting ideal, intermediate, or poor health status will be associated with a score of 2 to 0, respectively, creating a 0 to 14 scale of cardiovascular disease risk.

  20. Change from Baseline in Cardiovascular Disease Risk Score Assessed by Physical Activity [ Time Frame: week 1 and week 12 ]
    Assessed per the American Heart Association Life's Simple 7 index, which includes physical activity. To measure physical activity, the Garmin fitness activity tracker tracking will be used to determine the average number of daily minutes with moderate to vigorous physical activity, metabolic equivalents (METs) greater than or equal to 3 METs, in week 1 and week 12. Cardiovascular health risks will be summarized through a single risk score. For each risk indicator, meeting ideal, intermediate, or poor health status will be associated with a score of 2 to 0, respectively, creating a 0 to 14 scale of cardiovascular disease risk.

  21. Change from Baseline in Cardiovascular Disease Risk Score Assessed by Blood Sugar [ Time Frame: week 1 and week 12 ]
    Assessed per the American Heart Association Life's Simple 7 index, which includes blood sugar. Assessed via glycosylated hemoglobin percentage through the dried blood spot assay. Cardiovascular health risks will be summarized through a single risk score. For each risk indicator, meeting ideal, intermediate, or poor health status will be associated with a score of 2 to 0, respectively, creating a 0 to 14 scale of cardiovascular disease risk.

  22. Change from Baseline in Cardiovascular Disease Risk Score Assessed by Total Cholesterol [ Time Frame: week 1 and week 12 ]
    Assessed per the American Heart Association Life's Simple 7 index, which includes cholesterol. Assessed through the dried blood spot assay. Cardiovascular health risks will be summarized through a single risk score. For each risk indicator, meeting ideal, intermediate, or poor health status will be associated with a score of 2 to 0, respectively, creating a 0 to 14 scale of cardiovascular disease risk.

  23. Change in insulin requirements [ Time Frame: week 1 and week 12 ]
    Assessed by participant report from diabetes device data from insulin pumps or injection logs. This will include data from the 7 days prior to the baseline assessment and 7 days prior to the follow-up assessment.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 13-17 years old
  • At least 18 months post-diagnosis for type 1 diabetes
  • Parent reported moderate to no physical activity for adolescent
  • Ability to complete measures and intervention program in English
  • Access to broadband or cellular internet
  • Resides in and receives healthcare in the United States

Exclusion Criteria:

  • Ward of state
  • Active psychosis
  • Severe medical or psychiatric illness that limit participation (including any contraindications for physical activity)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05319600


Contacts
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Contact: Amy Hughes Lansing, PhD 802-656-3801 Amy.Hughes.Lansing@uvm.edu
Contact: Bridget Clark, MS 802-656-2692 bridget.clark@uvm.edu

Locations
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United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05401
Contact: Amy Hughes Lansing, PhD    802-656-3801    Amy.Hughes.Lansing@uvm.edu   
Principal Investigator: Amy Hughes Lansing, PhD         
Sponsors and Collaborators
University of Vermont
Investigators
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Principal Investigator: Amy Hughes Lansing, PhD University of Vermont
  Study Documents (Full-Text)

Documents provided by Amy Hughes Lansing, University of Vermont:
Informed Consent Form  [PDF] March 16, 2022

Publications:

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Responsible Party: Amy Hughes Lansing, Assistant Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT05319600    
Other Study ID Numbers: STUDY00001482
First Posted: April 8, 2022    Key Record Dates
Last Update Posted: April 8, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Overall analyses and de-identified data can be shared as described in participant consent, however, individual participant data will not be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amy Hughes Lansing, University of Vermont:
adolescents
physical activity intervention
diabetes self-management
behavior-change skills training
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases