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Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03531021
Recruitment Status : Completed
First Posted : May 21, 2018
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Joslin Diabetes Center

Brief Summary:
This study is evaluating how to encourage teens to engage in heart healthy behaviors such as being more active or eating in a healthy way. Teens will be randomly assigned to either the usual care group or the group with education, goal-setting, and lifestyle challenges with teammates.

Condition or disease Intervention/treatment Phase
Type1diabetes Cardiovascular Risk Factor Behavioral: Heart healthy intervention Not Applicable

Detailed Description:

Specific Aim: To develop and pilot test a modular intervention to improve heart healthy self-efficacy and behaviors in teens with type 1 diabetes at elevated cardiovascular disease risk.

Intervention Objective: To evaluate the feasibility and efficacy of a psychoeducational and behavioral intervention to improve heart healthy self-efficacy and behaviors in youth with type 1 diabetes (T1D) at elevated cardiovascular disease (CVD) CVD risk.

Secondary Objective: Assess participation in challenges involving healthy eating and physical activity.

Synopsis of Study Design

Study Design: Randomized, attention-matched trial with 1:1 randomization at a single center. Subjects will be randomized in two strata, by age (14-16 years and 17-19 years).

Study Population: Teens with type 1 diabetes.

Intervention: This pilot study involves a 6-month randomized controlled trial (RCT) comparing 2 study conditions, the behavioral intervention vs. an attention control. Youth will be randomized in 2 strata, by age (14-16 years and 17-19 years). Enrollment will end after 60 participants.

The intervention group will receive 2 modules (one in in person and one by video conference) and will receive follow-up phone calls/emails by study staff 3 weeks following each visit to review education and strategies for and barriers to reaching goals. Intervention sessions must include teen; parents may attend if they wish. Challenges will occur every 2 weeks. Participants will be on teams of about 3-5 teens and the teams may change over the course of the intervention due to staggered enrollment. As team members finish the study, newly randomized teammates will be assigned.

There will be a delayed intervention for the control group with study handouts after 3 months. The control group will meet with the research assistants (RAs) for demographic and survey completion and receive reminder phone calls/emails in order to match for attention.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, attention-matched trial with 1:1 randomization at a single center. Subjects will be randomized in two strata, by age (14-16 years and 17-19 years).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes: A Pilot Study
Actual Study Start Date : May 3, 2018
Actual Primary Completion Date : February 8, 2019
Actual Study Completion Date : February 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Heart healthy intervention
The intervention group will receive 2 modules (one in in person and one by video conference) and will receive follow-up phone calls/emails by study staff 3 weeks following each visit to review education and strategies for and barriers to reaching goals. Intervention sessions must include teen; parents may attend if they wish. Participants will be placed on teams and encouraged to complete behavioral challenges to earn points towards a cash reward.
Behavioral: Heart healthy intervention
Intervention consists of educational modules, goal setting and brainstorming around strategies and barriers, and a series of heart healthy challenges such as walking a certain number of steps or eating healthy foods a certain number of times in a week.

No Intervention: Attention Control
There will be a delayed intervention for the control group with study handouts after 3 months. The control group will meet with the RAs for demographic and survey completion and receive reminder phone calls/emails in order to match for attention.



Primary Outcome Measures :
  1. Adolescent Food Habits Checklist [ Time Frame: 3 months ]
    healthy eating questionnaire, 23 question true/false survey, score range from 0-23, higher scores indicate healthier habits, no subscales.


Secondary Outcome Measures :
  1. Adiposity [ Time Frame: 3 months ]
    changes in zbmi

  2. Blood pressure [ Time Frame: 3 months ]
    Changes in blood pressure percentile

  3. Changes in lipid levels [ Time Frame: 3 months ]
    Changes in lipid levels from before study until study end

  4. Activity level [ Time Frame: 3 months ]
    Documentation of how active participants were during study

  5. Exercise Confidence Survey [ Time Frame: 3 months ]
    evaluation of self-efficacy for exercise

  6. Healthy Eating Self-Efficacy Survey [ Time Frame: 3 months ]
    healthy eating self-efficacy measure

  7. Eating Habits Confidence Survey [ Time Frame: 3 months ]
    evaluation of how confident participants are that they can eat in a healthy way

  8. Acceptance of medication for CVD risk survey [ Time Frame: 3 months ]
    brief questions to evaluate willingness to take medication if prescribed

  9. Engagement with behavioral challenges [ Time Frame: 3 months ]
    Proportion of intervention participants who completed challenges

  10. Change in weight [ Time Frame: 3 months ]
    change in weight in kg between enrollment and study completion



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Teens ages 14-19 years old with T1D for ≥6 months
  • Current patients at Joslin Diabetes Center
  • Teens will have dyslipidemia (defined as LDL ≥100 mg/dl, HDL <40 mg/dl or triglycerides ≥130 mg/dl in past year), overweight or obesity (BMI percentile ≥85th at screening), prehypertensive or hypertensive blood pressure on day of screening visit, or A1c ≥8.0%
  • Youth and parents must be English speaking, without significant learning disabilities, and intend to continue care at our center.
  • Access to a smart phone with video conferencing capabilities

Exclusion Criteria:

  • Participation in an interventional study within the past 3 months.
  • Unwilling to comply with study procedures
  • Prescribed BP and/or lipid-lowering medications (besides over-the-counter supplements)
  • Contraindication to exercise

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): NCT03531021


Locations
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United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
Investigators
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Principal Investigator: Lori Laffel Joslin Diabetes Center
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Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT03531021    
Other Study ID Numbers: 2017-34
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Joslin Diabetes Center:
type 1 diabetes
cardiovascular risk factor
teenager
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