NCT06147973

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. 1.Does an acceptance-based healthy lifestyle intervention demonstrate more weight loss than a health education intervention?
  2. 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?
  3. 3.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.
  4. 4.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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress59%
Feb 2024Jan 2028

First Submitted

Initial submission to the registry

November 10, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 14, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

3.9 years

First QC Date

November 10, 2023

Last Update Submit

April 9, 2024

Conditions

Overweight and Obesity

Keywords

adolescent obesitycardiovascular disease riskhealthy lifestyle interventionacceptance-based

Outcome Measures

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.

    Month 6

Secondary Outcomes (9)

  • Physiological - Adiposity

    Month 6, month 12, month 18

  • Physiological - Blood pressure

    Month 6, month 12, month 18

  • Physiological - Blood lipids

    Month 6, month 12, month 18

  • Health-related behaviors - dietary intake

    Month 6, month 12, month 18

  • Health-related behaviors - physical activity

    Month 6, month 12, month 18

  • +4 more secondary outcomes

Study Arms (2)

Acceptance-based Treatment (ABT)

EXPERIMENTAL

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

Behavioral: Acceptance-based Treatment (ABT)

Health Education (HE) Comparison

SHAM COMPARATOR

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

Behavioral: Health Education (HE) Comparison

Interventions

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.

Acceptance-based Treatment (ABT)
Health Education (HE) ComparisonBEHAVIORAL

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

Health Education (HE) Comparison

Eligibility Criteria

Age14 Years - 19 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe participant must self-identify as female.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ages 14-19
  • Gender identification as girl
  • BMI percentile ≥ 85th percentile for sex-and-age

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (2)

  • Ogden CL, Carroll MD, Lawman HG, Fryar CD, Kruszon-Moran D, Kit BK, Flegal KM. Trends in Obesity Prevalence Among Children and Adolescents in the United States, 1988-1994 Through 2013-2014. JAMA. 2016 Jun 7;315(21):2292-9. doi: 10.1001/jama.2016.6361.

    PMID: 27272581BACKGROUND

  • Newsome FA, Cardel MI, Chi X, Lee AM, Miller D, Menon S, Janicke DM, Gurka MJ, Butryn ML, Manasse S. Wellness Achieved Through Changing Habits: A Randomized Controlled Trial of an Acceptance-Based Intervention for Adolescent Girls With Overweight or Obesity. Child Obes. 2023 Dec;19(8):525-534. doi: 10.1089/chi.2022.0116. Epub 2022 Nov 17.

    PMID: 36394498BACKGROUND

MeSH Terms

Conditions

OverweightObesityPediatric Obesity

Interventions

Helium

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Noble GasesElementsInorganic ChemicalsGases

Study Officials

  • Stephanie Manasse, PhD

    Drexel University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Manasse, PhD

CONTACT

215-553-7157smm522@drexel.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to either an acceptance-based treatment intervention or a health education comparison for the duration of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 10, 2023

First Posted

November 28, 2023

Study Start

February 14, 2024

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

De-identified data will be shared with the study Data Safety Monitoring Board (DSMB). Following study close-out, de-identified data and related data dictionaries will be available upon request.

Time Frame
Data will be available upon request following the conclusion of the study.
Access Criteria
For access, interested parties must contact the principal investigator.

Locations

US(1)