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

August 5, 2024 updated by: Colorado State University
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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biofeedback
Behavioral: Biofeedback
Heart-rate Variability Biofeedback
Other: Waitlist
Other: Waitlist
Waitlist control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facilitator Protocol
Time Frame: Year 1
4-session biofeedback facilitator protocol
Year 1
Feasibility/Acceptability
Time Frame: 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.
Year 1
Stress Physiology
Time Frame: Year 2
Year 2
Stress Eating
Time Frame: Year 2
Year 2
Inflammatory Biomarkers
Time Frame: Year 2
Year 2
Insulin Sensitivity
Time Frame: Year 2
Year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado State University

Collaborators

University of Colorado, Denver
Children's Hospital Colorado

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2023

Primary Completion (Estimated)

January 1, 2023

Study Completion (Estimated)

January 1, 2023

Study Registration Dates

First Submitted

August 2, 2023

First Submitted That Met QC Criteria

August 2, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5P30DK048520-29 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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