RECRUITING

An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents

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Conditions

Overweight and Obesityadolescent obesitycardiovascular disease riskhealthy lifestyle interventionacceptance-based

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Wellness Achieved Through Changing Habits (WATCH): An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents

Quick Facts

Study Start:2024-02-14
Study Completion:2028-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06147973

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.

Ages Eligible for Study:14 Years to 19 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages 14-19
  2. * Gender identification as girl
  3. * BMI percentile ≥ 85th percentile for sex-and-age
  1. * Experience of weight loss of ≥5% of body weight in the past 6 months for any reason except post-partum weight loss
  2. * Having recently begun or changed the dosage of any medication known to affect appetite or body composition within the last 3 months
  3. * Plans to move out of the area within the next year
  4. * Active cancer or cancer requiring treatment in the past 2 years (except non-melanoma skin cancer)
  5. * Active or chronic infections (e.g., HIV or TB)
  6. * Active cardiovascular disease or event including hospitalization or therapeutic procedures for treatment of heart disease in the past 6 months
  7. * Active kidney disease
  8. * History of bariatric surgery
  9. * Lung disease: chronic obstructive airway disease requiring use of oxygen (e.g., emphysema or chronic bronchitis)
  10. * Diagnosed diabetes (type 1 or 2)
  11. * Any condition prohibiting physical activity
  12. * Diagnosis of an eating disorder
  13. * 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)
  14. * Recent or ongoing problem with drug abuse, alcohol abuse, or addiction
  15. * Currently pregnant or less than 3 months post-partum
  16. * Anticipation of a possible pregnancy in the next year
  17. * Unwillingness to report possible or confirmed pregnancies promptly during the course of the trial

Contacts and Locations

Study Contact

Stephanie Manasse, PhD
CONTACT
215-553-7157
smm522@drexel.edu

Principal Investigator

Stephanie Manasse, PhD
PRINCIPAL_INVESTIGATOR
Drexel University

Study Locations (Sites)

Drexel University
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Drexel University

  • Stephanie Manasse, PhD, PRINCIPAL_INVESTIGATOR, Drexel University

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

Study Start Date2024-02-14
Study Completion Date2028-01-01

Study Record Updates

Study Start Date2024-02-14
Study Completion Date2028-01-01

Terms related to this study

Keywords Provided by Researchers

  • adolescent obesity
  • cardiovascular disease risk
  • healthy lifestyle intervention
  • acceptance-based

Additional Relevant MeSH Terms

  • Overweight and Obesity