Piloting a Biofeedback Intervention for Adolescents With Overweight and a History of Adverse Childhood Experiences
Primary Purpose
Obesity, Adolescent
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Biofeedback
Waitlist
Sponsored by
About this trial
This is an interventional prevention trial for Obesity, Adolescent
Eligibility 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Biofeedback
Waitlist
Arm Description
Outcomes
Primary Outcome Measures
Facilitator Protocol
4-session biofeedback facilitator protocol
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.
Stress Physiology
Stress Eating
Inflammatory Biomarkers
Insulin Sensitivity
Secondary Outcome Measures
Full Information
NCT ID
NCT05984043
First Posted
August 2, 2023
Last Updated
August 2, 2023
Sponsor
Colorado State University
Collaborators
Children's Hospital Colorado, University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT05984043
Brief Title
Piloting a Biofeedback Intervention for Adolescents With Overweight and a History of Adverse Childhood Experiences
Official Title
Piloting a Biofeedback Intervention for Adolescents With Overweight and a History of Adverse Childhood Experiences
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Colorado State University
Collaborators
Children's Hospital Colorado, University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Adolescent
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biofeedback
Arm Type
Experimental
Arm Title
Waitlist
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback
Intervention Description
Heart-rate Variability Biofeedback
Intervention Type
Other
Intervention Name(s)
Waitlist
Intervention Description
Waitlist control group
Primary Outcome Measure Information:
Title
Facilitator Protocol
Description
4-session biofeedback facilitator protocol
Time Frame
Year 1
Title
Feasibility/Acceptability
Description
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.
Time Frame
Year 1
Title
Stress Physiology
Time Frame
Year 2
Title
Stress Eating
Time Frame
Year 2
Title
Inflammatory Biomarkers
Time Frame
Year 2
Title
Insulin Sensitivity
Time Frame
Year 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth B Ruzicka, PhD
Phone
7207770816
Email
elizabeth.ruzicka@childrenscolorado.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Piloting a Biofeedback Intervention for Adolescents With Overweight and a History of Adverse Childhood Experiences
We'll reach out to this number within 24 hrs