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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
Colorado State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Adolescent

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 2, 2023
    Last Updated
    August 2, 2023
    Sponsor
    Colorado State University
    Collaborators
    Children's Hospital Colorado, University of Colorado, Denver
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    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

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