NCT06745570

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

Improving Sleep As a Method for Enhancing Decision-Making and Reducing Problematic Eating Behaviors in Adolescents with Obesity

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Drexel University · Academic / Other
• Sex: All
• Age: 14 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this study, the investigators will develop, refine, and test a 16-session group-based lifestyle modification intervention for adolescents with overweight and obesity augmented with a sleep intervention. The investigators will develop the manual and pilot the intervention in an initial set of adolescents (n=10). The investigators will collect feedback from adolescents, parents, and clinicians, which will inform manual refinements. The investigators will complete an open trial (n=40) of the refined manual. For both phases, the investigators will recruit adolescents (ages 14-18) with overweight or obesity who endorse at least 1 type of sleep disturbance (i.e., too little, poor quality, poorly timed, or inconsistent sleep). Assessments of sleep, decision-making, problematic eating behaviors, energy intake, and weight will occur at baseline (week 0), mid-intervention (week 8) and post-intervention (week 16).

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-18
• Primary completion: 2026-06-15
• Completion: 2027-01-31
• First posted: 2024-12-20
• Last updated: 2024-12-20

Locations

1 site across 1 country: United States