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

Part of paid clinical trials in Wilmington, Delaware.

Sponsor
Nemours Children's Clinic
Study ID
NCT06745570
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
14 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Lifestyle Modification and Sleep Intervention — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Dec 20, 2024
Start date
Apr 18, 2024
Status verified
Jul 2026
Primary completion
Jan 15, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group Intervention
    All participants will receive group-based lifestyle modification and sleep treatment (16, 90-minute sessions over 16 weeks). All sessions will be delivered on Zoom (remotely) to small groups (n=5-10 each) of participants. The intervention involves lifestyle modification content (e.g., nutritional education, physical activity education, stimulus control, goal setting) and sleep content (e.g., psychoeducation regarding sleep and eating behavior, sleep tracking, establishing regular sleep-wake times).

Primary Outcome Measure

Percent of 95th percentile BMI [ Time Frame: From enrollment to the end of the study (approximately 4 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nemours Children's ClinicWilmingtonDelaware19803
Stephanie Manasse, Ph.D.
[email protected]
(215) 553-7500

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