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Improving Sleep, Decision-Making, and Eating in Adolescents with Obesity

NCT06745570 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-12-20

No results posted yet for this study

Summary

This study is being performed to understand the effects of a lifestyle modification and sleep intervention on weight loss outcomes in adolescence. The main question the study aims to answer is:

\- What are the initial effects of a lifestyle modification and sleep intervention, including effects on weight, eating behaviors and dietary intake, and sleep?

Participants will:

* Participate in remote, group-based, weekly weight loss and sleep coaching for 16 weeks.
* Complete study assessments at baseline (pre-intervention), mid-intervention, and post-intervention.
* Complete daily sleep diaries for three 7-day periods at each assessment point.

Conditions

  • Adolescent Overweight
  • Adolescent Obesity
  • Sleep
  • Eating Behaviors
  • Dietary Intake

Interventions

BEHAVIORAL

Lifestyle Modification and Sleep Intervention

This study is being performed to develop, refine, and test the effects of a group lifestyle modification intervention augmented with a sleep intervention on weight loss, eating behaviors, and sleep outcomes. Results from this study will inform future studies to test the efficacy of this intervention. This intervention is being offered as part of a research study within Drexel University's WELL Center. Participants will receive remote, group-based, weekly weight loss and sleep coaching (90 minutes per coaching session) for 16 weeks.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Drexel University

    lead OTHER

Principal Investigators

  • Stephanie Manasse, Ph.D. · Drexel University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-18
Primary Completion
2026-06-15
Completion
2027-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06745570 on ClinicalTrials.gov