Clinical trial

An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents

Recruiting now · Not applicable · 1 countries · Registry ID NCT06147973

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age14 Years to 19 Years
SexFemale
Healthy volunteersAccepted
ConditionOverweight and Obesity

Full registry criteria

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

Treatments and study arms

Acceptance-based Treatment (ABT)

Behavioral

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

Health Education (HE) Comparison

Behavioral

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 outcomes

BMI z-score changeMonth 6

Compare ABT vs. HE on BMI z-score change at post-treatment (month 6). The investigators hypothesize a significantly greater decrease in BMI z-scores in the ABT relative to HE.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Drexel University🇺🇸 Philadelphia, Pennsylvania, United States
Stephanie Manasse, PhDContact