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

NCT05984043 | Withdrawn

• 1 other identifier: 5P30DK048520-29
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Obesity, Adolescent

Outcome Measures

Primary Outcomes (6)

• Facilitator Protocol

  4-session biofeedback facilitator protocol

  Year 1

• 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

• Stress Physiology

  Year 2

• Stress Eating

  Year 2

• Inflammatory Biomarkers

  Year 2

• Insulin Sensitivity

  Year 2

Study Arms (2)

Biofeedback

EXPERIMENTAL

Behavioral: Biofeedback

Waitlist

OTHER

Other: Waitlist

Interventions

Biofeedback BEHAVIORAL

Heart-rate Variability Biofeedback

Biofeedback

Waitlist OTHER

Waitlist control group

Waitlist

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Four or more ACEs
• BMI at or above the 85th percentile;

You may not qualify if:

• 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)

Sponsors & Collaborators

• Colorado State University: lead
• Children's Hospital Colorado: collaborator
• University of Colorado, Denver: collaborator

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Biofeedback, Psychology; Waiting Lists

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Appointments and Schedules; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 9, 2023
• Study Start: January 1, 2023
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share