Recruiting

Healthy Lifestyle Intervention

Sponsor:

Nemours Children's Clinic

Code:

NCT06147973

Conditions

Overweight and Obesity

Eligibility Criteria

Sex: Female

Age: 14 - 19

Healthy Volunteers: Accepted

Interventions

Acceptance-based Treatment (ABT)

Health Education (HE) Comparison

Study Details

Brief summary:

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 ID

NCT06147973

Start date

Feb 14, 2024

Status verified date

Jul, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 14 - 19

Healthy Volunteers: Accepted

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

Study Design

Enrollment

148 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acceptance-based Treatment (ABT)

ABT will consist of 18, 90-minute group sessions over 6 months.

sham comparator: Health Education (HE) Comparison

HE will include nine, 75-minute group health education sessions handouts over 6 months.

Interventions

Acceptance-based Treatment (ABT)

Participants will be provided with psycho-education, skill-builders, and other coaching to promote weight loss and healthy lifestyle changes.

Health Education (HE) Comparison

Participants will be provided with psych-education and resources to promote weight loss and healthy lifestyle changes. They will not be provided with directives.

Primary outcome measure

  • BMI z-score change [ Time Frame: Month 6 ]

Central Contacts and Locations

Central contacts

Stephanie Manasse, PhD

215-553-7157smm522@drexel.edu

Locations

Drexel University

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Stephanie Manasse, PhD

2155537157smm522@drexel.edu

More Information

Sponsor

Nemours Children's Clinic

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nemours Children's Clinic on 2026-07-20.