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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05984043
Other study ID # 5P30DK048520-29
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 2023
Est. completion date July 2025

Study information

Verified date August 2023
Source Colorado State University
Contact Elizabeth B Ruzicka, PhD
Phone 7207770816
Email elizabeth.ruzicka@childrenscolorado.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Adverse childhood experiences (ACEs), referring to traumatic experiences occurring before 18 years of age (e.g., abuse/neglect), are associated with a 30-70% increased risk of developing adolescent and adult obesity and obesity-related cardiometabolic comorbidities, which may be due to dysregulation in stress-related physiology and engagement in stress-related behaviors. While adolescents with ACEs have a 2.25 times increased risk of obesity, standard-of-care lifestyle (e.g., nutrition/physical activity) interventions do not typically incorporate trauma-informed care, including assessment and therapeutic attention to effects of ACEs. Heart rate variability (HRV) biofeedback is an evidence-based, relatively brief, mind-body intervention targeting the stress physiology that can be dysregulated in adolescents with ACEs. The objective of this proposal is to adapt and test a 4-session HRV biofeedback protocol for 12-17-year-olds with BMI>85th percentile and ACEs. First (Phase 1), we will iteratively adapt a 4-session HRV biofeedback facilitator protocol with n=3-5 adolescents with overweight/obesity and ACEs, using adolescent quantitative and qualitative feedback to hone and optimize HRV biofeedback for this population (Aim 1). Next (Phase 2), we will conduct a randomized waitlist-controlled pilot study of n=30 adolescents with overweight/obesity and ACEs to assess acceptability and feasibility (Aim 2) and to describe changes in theorized targets of biofeedback (Aim 3).


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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Biofeedback
Heart-rate Variability Biofeedback
Other:
Waitlist
Waitlist control group

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Colorado State University Children's Hospital Colorado, University of Colorado, Denver

Outcome

Type Measure Description Time frame Safety issue
Primary Facilitator Protocol 4-session biofeedback facilitator protocol Year 1
Primary Feasibility/Acceptability Protocol implementation will be feasible in terms of recruitment (=60% eligible enroll), intervention adherence (=80% will receive >80% dosage), baseline/post-treatment assessment adherence (<20% missing data), and post-treatment retention (=80%). Biofeedback will be acceptable based on session likeability ratings (80% >4:5) and qualitative themes assessed by interview indicative of likeability/benefit. Year 1
Primary Stress Physiology Year 2
Primary Stress Eating Year 2
Primary Inflammatory Biomarkers Year 2
Primary Insulin Sensitivity Year 2
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