NCT04848532

Brief Summary

This study evaluates the associations between baseline decision-making processes, engagement in problematic dietary practices, and post-intervention weight loss outcomes among adolescents. Results from the study will provide specific direction for what components should comprise future decision-making interventions for adolescents with overweight/obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 17, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

3.7 years

First QC Date

March 17, 2021

Last Update Submit

June 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percent of 95 percentile BMI

    16 weeks

Study Arms (1)

Adolescent-specific behavioral weight loss treatment

EXPERIMENTAL
Behavioral: Weight loss treatment

Interventions

The intervention will consist of group-based, weekly or biweekly weight loss coaching (75 minutes per session), which will occur via Zoom videoconferencing software. This intervention is designed to facilitate a 5-10% weight loss and engagement in up to 250 min/week of moderate-to-vigorous physical activity, which is the standard recommendation in lifestyle modification programs for adolescents. Participants will also be asked to download and utilize the smartphone app, Fitbit, to track eating behavior. Weight loss coaches will be experts in lifestyle modification who have graduate degrees in psychology or a related field. Participants will be given guidance on how to reduce your calorie intake (using a balanced deficit diet) and gradually increase your physical activity. Participants will learn to set goals for diet, weight, and physical activity.

Also known as: Lifestyle modification
Adolescent-specific behavioral weight loss treatment

Eligibility Criteria

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

You may qualify if:

  • Are between 14 and 18 years of age
  • Have a BMI between the 85th and 99th percentiles for sex and age as determined by the CDC growth charts
  • Are currently living at home with a parent or guardian
  • Have at least one parent or guardian who is willing to participate in the study
  • Are willing to complete baseline assessment tasks
  • Have a smartphone, are willing to download an app to track food intake and complete surveys on the phone for two seven-day periods throughout the course of the study, and are willing to wear a fitness tracker during these same two week-long periods
  • Are located in the US and wiling/able to participate in remote intervention and assessments

You may not qualify if:

  • Acute suicide risk
  • Inability to engage in physical activity (defined as walking two city blocks without stopping)
  • Have diabetes or a history of bariatric surgery
  • Current medical or psychiatric condition that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to comply with the program (i.e., bulimia nervosa, substance abuse disorder, psychosis, bipolar I disorder, and/or any condition prohibiting physical activity)
  • Are pregnant or planning to become pregnant in the next 2 years
  • Recently began or changed the dose of a medication that can cause significant change in weight
  • Have experienced weight loss ≥ 5% in the previous 6 months
  • Are planning to begin in the next 16 months, or are currently participating in, another weight loss treatment or psychotherapy for binge eating and/or weight loss
  • Are engaging in compensatory vomiting, other severe compensatory behaviors, or more than 12 of any compensatory behaviors in the previous 3 months
  • Are currently taking medication (e.g., Contrave, Alli, etc.) which is specifically intended for weight loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

OverweightObesityImpulsive BehaviorHyperphagia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Stephanie Manasse, Ph.D.

    Drexel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2021

First Posted

April 19, 2021

Study Start

February 3, 2021

Primary Completion

October 15, 2024

Study Completion

April 30, 2025

Last Updated

June 13, 2025

Record last verified: 2025-06

Locations