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

Not Applicable

Withdrawn

• Conditions: Obesity, Adolescent
• Interventions: Other: Waitlist; Behavioral: Biofeedback

• Registration Number: NCT05984043
• Lead Sponsor: Colorado State University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01
• Primary Completion: 2023-01
• Study Completion: 2023-01
• Study First Submitted: 2023-08-02
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Waitlist	Waitlist	-
Biofeedback	Biofeedback	-

Primary Outcome Measures

Name	Time	Method
Stress Physiology	Year 2
Inflammatory Biomarkers	Year 2
Facilitator Protocol	Year 1	4-session biofeedback facilitator protocol
Stress Eating	Year 2
Insulin Sensitivity	Year 2
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.