Piloting a Biofeedback Intervention for Adolescents With Overweight and a History of Adverse Childhood Experiences

Obesity, Adolescent Clinical Trial

Official title:

Piloting a Biofeedback Intervention for Adolescents With Overweight and a History of Adverse Childhood Experiences

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05984043
• Other study ID #: 5P30DK048520-29
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity, Adolescent
• Overweight
• Pediatric Obesity

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