NCT04484831

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 12, 2023

Completed
Last Updated

October 12, 2023

Status Verified

September 1, 2023

Enrollment Period

12 months

First QC Date

July 21, 2020

Results QC Date

July 7, 2023

Last Update Submit

September 20, 2023

Conditions

Weight LossObesityOverweight

Keywords

acceptance-based therapyadolescentsweightweight lossobesityoverweight

Outcome Measures

Primary Outcomes (1)

  • BMI Change, 95th BMI Percentile (%)

    Changes in weight relative to the BMI at the 95th percentile based on sex-and-age (as a difference in percentage units and/or a difference in BMI units) will be evaluated.

    Baseline; Month 6

Secondary Outcomes (3)

  • Change in Quality of Life

    Baseline; Month 6

  • Change in Depression Using the Valid Beck Depression Inventory-II

    Baseline; Month 6

  • Change in Anxiety-sensitivity Using the Valid Short Scale Anxiety Sensitivity Index Assessment

    Baseline; Month 6

Study Arms (2)

ABT Weight Loss Intervention

EXPERIMENTAL

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.

Behavioral: ABT Weight Loss Intervention

Enhanced Care

PLACEBO COMPARATOR

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.

Other: Enhanced Care

Interventions

ABT Weight Loss InterventionBEHAVIORAL

This includes 15 sessions that are each 90 minutes in length. Intervention sessions will be weekly for the first 2 months, bi-weekly for the next 2 months, and monthly for the last 2 months.

ABT Weight Loss Intervention
Enhanced CareOTHER

This includes 15 handouts on elements of a healthy lifestyle and a midpoint one-on-one nutrition consultation with a registered dietitian.

Enhanced Care

Eligibility Criteria

Age14 Years - 19 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Weight LossObesityOverweightBody Weight

Condition Hierarchy (Ancestors)

Body Weight ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Results Point of Contact

Title
Dr. Michelle Cardel, Adjunct Professor
Organization
University of Florida
mcardel@ufl.edu
352-273-8811

Study Officials

  • Michelle I Cardel, PhD, MS, RD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 24, 2020

Study Start

July 21, 2020

Primary Completion

July 7, 2021

Study Completion

July 22, 2022

Last Updated

October 12, 2023

Results First Posted

October 12, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)