An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents
The goal of this clinical trial is to learn about cardiovascular disease risk among adolescent girls with overweight/obesity. The main questions this trial aims to answer are: 1. Does an acceptance-based healthy lifestyle intervention demonstrate more weight loss than a health education intervention? 2. Does an acceptance-based healthy lifestyle intervention show more improvements in participants' physiological, health-related, and psychological factors compared to a health education intervention? Participants in this trial will: 1. Engage in treatment for 6-months, comprising of a mixture of in-person and remote group sessions, occurring at Drexel University or over a video-conferencing platform. 2. Complete various assessments. These include self-reported questionnaires, measures of weight, height, body composition, blood pressure, and blood lipids, and wearing of smart watches to measure sleep and physical activity. Researchers will compare the acceptance-based and health education intervention groups to see if the acceptance-based treatment will indeed be effective in improving participants' health outcomes.
Conditions:
🦠 Overweight and Obesity
🗓️ Study Start (Actual) 14 February 2024
🗓️ Primary Completion (Estimated) 1 January 2028
✅ Study Completion (Estimated) 1 January 2028
👥 Enrollment (Estimated) 148
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Ages 14-19
    • * Gender identification as girl
    • * BMI percentile ≥ 85th percentile for sex-and-age

    Exclusion Criteria:

    • * Experience of weight loss of ≥5% of body weight in the past 6 months for any reason except post-partum weight loss
    • * Having recently begun or changed the dosage of any medication known to affect appetite or body composition within the last 3 months
    • * Plans to move out of the area within the next year
    • * Active cancer or cancer requiring treatment in the past 2 years (except non-melanoma skin cancer)
    • * Active or chronic infections (e.g., HIV or TB)
    • * Active cardiovascular disease or event including hospitalization or therapeutic procedures for treatment of heart disease in the past 6 months
    • * Active kidney disease
    • * History of bariatric surgery
    • * Lung disease: chronic obstructive airway disease requiring use of oxygen (e.g., emphysema or chronic bronchitis)
    • * Diagnosed diabetes (type 1 or 2)
    • * Any condition prohibiting physical activity
    • * Diagnosis of an eating disorder
    • * Have a mental handicap or are currently experiencing other severe psychopathology that would limit their ability to engage in the treatment program (e.g., severe depression, active psychotic disorder)
    • * Recent or ongoing problem with drug abuse, alcohol abuse, or addiction
    • * Currently pregnant or less than 3 months post-partum
    • * Anticipation of a possible pregnancy in the next year
    • * Unwillingness to report possible or confirmed pregnancies promptly during the course of the trial
Ages Eligible for Study: 14 Years to 19 Years (CHILD, ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ 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 Registration Dates

  • First Submitted 10 November 2023
  • First Submitted that Met QC Criteria 17 November 2023
  • First Posted 28 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 April 2024
  • Last Update Posted 10 April 2024
  • Last Verified April 2024