Obesity, Adolescent
Conditions
Brief 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).
Interventions
BEHAVIORALBiofeedback
Heart-rate Variability Biofeedback
OTHERWaitlist
Waitlist control group
Sponsors
Children's Hospital Colorado
University of Colorado, Denver
Colorado State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Four or more ACEs * BMI at or above the 85th percentile;
Exclusion criteria
* Major renal, hepatic, endocrinologic, rheumatologic, cardiac, or pulmonary medical problem likely to affect mood or weight * Medications affecting mood or weight (e.g. anti-anxiety/depressants/psychotics, stimulants, mood stabilizers, insulin sensitizers, weight loss)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Facilitator Protocol | Year 1 | 4-session biofeedback facilitator protocol |
| Feasibility/Acceptability | Year 1 | 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. |
| Stress Physiology | Year 2 | — |
| Stress Eating | Year 2 | — |
| Inflammatory Biomarkers | Year 2 | — |
| Insulin Sensitivity | Year 2 | — |
Outcome results
None listed