- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03531021
Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes
Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes: A Pilot Study
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02215
- Joslin Diabetes Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
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.
|
Inget ingripande: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Adolescent Food Habits Checklist
Tidsram: 3 months
|
healthy eating questionnaire, 23 question true/false survey, score range from 0-23, higher scores indicate healthier habits, no subscales.
|
3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Adiposity
Tidsram: 3 months
|
changes in zbmi
|
3 months
|
Blood pressure
Tidsram: 3 months
|
Changes in blood pressure percentile
|
3 months
|
Changes in lipid levels
Tidsram: 3 months
|
Changes in lipid levels from before study until study end
|
3 months
|
Activity level
Tidsram: 3 months
|
Documentation of how active participants were during study
|
3 months
|
Exercise Confidence Survey
Tidsram: 3 months
|
evaluation of self-efficacy for exercise
|
3 months
|
Healthy Eating Self-Efficacy Survey
Tidsram: 3 months
|
healthy eating self-efficacy measure
|
3 months
|
Eating Habits Confidence Survey
Tidsram: 3 months
|
evaluation of how confident participants are that they can eat in a healthy way
|
3 months
|
Acceptance of medication for CVD risk survey
Tidsram: 3 months
|
brief questions to evaluate willingness to take medication if prescribed
|
3 months
|
Engagement with behavioral challenges
Tidsram: 3 months
|
Proportion of intervention participants who completed challenges
|
3 months
|
Change in weight
Tidsram: 3 months
|
change in weight in kg between enrollment and study completion
|
3 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Lori Laffel, Joslin Diabetes Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2017-34
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