A Trial to Test an Acceptance-based Therapy Program Among Adolescent Girls With Overweight/Obesity

University of Florida

Status: Completed

Conditions: Weight Loss; Overweight; Obesity

Treatments: Other: Enhanced Care; Behavioral: ABT Weight Loss Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04484831

K01HL141535 (U.S. NIH Grant/Contract)

IRB201701609

PA-16-190 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to investigate the effects of an acceptance-based therapy weight loss intervention compared with enhanced care for adolescents.

Full description

Participants will complete baseline assessments and adolescents will be randomized to either an ABT weight loss intervention or enhanced care.

The intervention will include 15 sessions over 6 months. Enhanced care will include 15 healthy lifestyle handouts over 6 months.

Post-treatment assessments will occur.

Enrollment: 43 patients

Sex: Female

Ages: 14 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adolescent between ages 14-19 with overweight or obesity at or above the 85th percentile for sex and age as determined by CDC growth charts

Exclusion criteria

• Known pregnancy or plans to become pregnant in the next 2 years
• Plans to move out of the area in the next year
• Autism, any intellectual disability (e.g., down syndrome)
• Any condition prohibiting physical activity
• A diagnosis of cardiovascular disease or diabetes
• Have active cancer or cancer requiring treatment in the past 2 years
• Have active or chronic infections (e.g., HIV or TB)
• Have active kidney disease or lung disease
• An eating disorder or substance abuse disorder
• Having recently begun a course of or changed the dosage of any medications known to affect appetite or body composition
• Weight loss greater than or equal to 5% in the previous 6 months
• If they do not follow the study plan

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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43 participants in 2 patient groups, including a placebo group

ABT Weight Loss Intervention

Experimental group

Description:

Adolescent participants will attend sessions that include nutritional education and physical activity education and build skills in the areas of values clarification, mindfulness, self-regulation skills, acceptance of uncomfortable states, goal-setting, problem solving, and self-monitoring.

Treatment:

Behavioral: ABT Weight Loss Intervention

Enhanced Care

Placebo Comparator group

Description:

Adolescent participants will receive handouts on elements of a healthy lifestyle and will participate in a midpoint one-on-one nutrition consultation with a registered dietitian.

Treatment:

Other: Enhanced Care