An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents
ConditionOverweight and Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age14-19
SponsorNemours Children's Clinic
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ages 14-19
Gender identification as girl
BMI percentile ≥ 85th percentile for sex-and-age
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Acceptance-based Treatment (ABT)
BehavioralParticipants will be provided with psycho-education, skill-builders, and other coaching to promote weight loss and healthy lifestyle changes.
Health Education (HE) Comparison
BehavioralParticipants will be provided with psych-education and resources to promote weight loss and healthy lifestyle changes. They will not be provided with directives.
Treatment groups
148 Participants
are divided into 2 treatment groupsGroup A: Acceptance-based Treatment (ABT)Experimental treatment 1 intervention
Group B: Health Education (HE) ComparisonSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
BMI z-score change
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.
Time frame
Month 6Secondary outcomes
1
Physiological - Adiposity
Compare change in percent body fat in ABT relative to HE
Time frame
Month 6, month 12, month 182
Physiological - Blood pressure
Compare change in diastolic and systolic blood pressure in ABT relative to HE
Time frame
Month 6, month 12, month 183
Physiological - Blood lipids
Compare change in total blood lipid levels in ABT relative to HE. HDL, LDL, and total cholesterol will each be examined.
Time frame
Month 6, month 12, month 184
Health-related behaviors - dietary intake
Compare change in dietary intake in ABT relative to HE. Dietary intake will be measured with a VioScreen Food Frequency Questionnaire.
Time frame
Month 6, month 12, month 18Sponsors and contacts
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Source ClinicalTrials.gov