Improving Sleep, Decision-Making, and Eating in Adolescents With Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-18
SponsorNemours Children's Clinic
About this trial
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.
Eligibility criteria
Qualifiers
Ages 14-18
Fluent in English
BMI percentile ≥ 85th percentile for sex-and-age
Has a parent or guardian who is willing and able to participate
Disqualifiers
Experience of weight loss of ≥ 5% of body weight in the past 6 months
Current use of insomnia medication
Having recently begun or changed the dosage of any medication known to affect appetite or body composition within the last 3 months
Currently taking weight loss medications
Trial design
Treatments tested in this trial
- Lifestyle Modification and Sleep Intervention
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Nemours Children's Clinic
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov