Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06745570

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age14 Years to 18 Years
SexAll
Healthy volunteersNot accepted
ConditionAdolescent Overweight, Adolescent Obesity, Sleep, Eating Behaviors, Dietary Intake

Full registry criteria

Inclusion Criteria: * 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 * Has at least one sleep disturbance. Eligible sleep disturbances are: a. Advanced sleep timing (sleep onset 11:00pm or later for 14-16 year-olds or 11:20pm or later for 17-18 year-olds at least 3 times per week), b. Difficulty falling asleep (taking ≥ 30 mins to get to sleep 3 or more nights per week), c. Short sleep (obtaining \< 7.5 hours of sleep per night 3 or more nights per week), and d. Sleep irregularity (having more than 2 hours of variability in sleep-wake schedule across one week Exclusion Criteria: * 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 * Currently taking insulin * Diagnosed diabetes (type 1) * Any condition prohibiting physical activity * Diagnosis of an eating disorder * Diagnosis of obstructive sleep apnea * Recent or ongoing problem with drug abuse, alcohol abuse, or addiction * Currently pregnant or less than 3 months postpartum * Anticipation of a possible pregnancy in the next year * Unwillingness to report possible or confirmed pregnancies promptly during the course of the trial * Currently participating in treatment for eating or weight concerns * Does not have regular access to Wi-Fi connection to participate in study interventions.

Treatments and study arms

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.

Primary outcomes

Percent of 95th percentile BMIFrom enrollment to the end of the study (approximately 4 months)

Height and weight will be measured at each assessment and used to calculate percent of 95th percentile BMI.

Tri-ponderal mass indexFrom enrollment to the end of the study (approximately 4 months)

The investigators will also calculate tri-ponderal mass index (TMI; i.e., mass divided by height cubed) from measurements of height and weight.

Body fat percentageFrom enrollment to the end of the study (approximately 4 months)

Body fat percentage will also be derived from the Aria Air scale.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Nemours Children's Clinic🇺🇸 Wilmington, Delaware, United States
Stephanie Manasse, Ph.D.Contact