Recruiting

Lifestyle Modification

Sponsor:

Nemours Children's Clinic

Code:

NCT06745570

Conditions

Adolescent Overweight

Adolescent Obesity

Sleep

Eating Behaviors

Dietary Intake

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Not accepted

Interventions

Lifestyle Modification and Sleep Intervention

Study Details

Brief 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

Study ID

NCT06745570

Start date

Apr 18, 2024

Status verified date

Jul, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

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.

Primary outcome measure

  • Percent of 95th percentile BMI [ Time Frame: From enrollment to the end of the study (approximately 4 months) ]
  • Tri-ponderal mass index [ Time Frame: From enrollment to the end of the study (approximately 4 months) ]
  • Body fat percentage [ Time Frame: From enrollment to the end of the study (approximately 4 months) ]

Central Contacts and Locations

Central contacts

Stephanie Manasse, Ph.D

3022988390aspirelab@nemours.org

Locations

Nemours Children's Clinic

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Stephanie Manasse, Ph.D.

(215) 553-7500wellteen@drexel.edu

More Information

Sponsor

Nemours Children's Clinic

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • Adolescent Weight Loss
  • Adolescent Sleep
  • Adolescent Eating

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nemours Children's Clinic on 2026-07-20.