Piloting a Biofeedback Intervention for Adolescents With Overweight and a History of Adverse Childhood Experiences
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Biofeedback
|
Behavioral: Biofeedback
Heart-rate Variability Biofeedback
|
| Other: Waitlist
|
Other: Waitlist
Waitlist control group
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Colorado State University
- Children's Hospital Colorado
- University of Colorado, Denver
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5P30DK048520-29