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

NCT06745570 | Active Not Recruiting DMC

• 2 other identifiers: 2310010117R03DK138216
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Adolescent Weight Loss; Adolescent Sleep; Adolescent Eating

Outcome Measures

Primary Outcomes (3)

• Percent of 95th percentile BMI

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

  From enrollment to the end of the study (approximately 4 months)

• Tri-ponderal mass index

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

  From enrollment to the end of the study (approximately 4 months)

• Body fat percentage

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

  From enrollment to the end of the study (approximately 4 months)

Secondary Outcomes (11)

• Dietary intake

  From enrollment to the end of the study (approximately 4 months)

• Eating Disorder Examination

  From enrollment to the end of the study (approximately 4 months)

• Eating Disorder Examination Questionnaire

  From enrollment to the end of the study (approximately 4 months)

• Average total sleep time

  From enrollment to the end of the study (approximately 4 months)

• Average bed time

  From enrollment to the end of the study (approximately 4 months)

Study Arms (1)

Group Intervention

EXPERIMENTAL

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).

Behavioral: Lifestyle Modification and Sleep Intervention

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.

Group Intervention

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Drexel University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Drexel University WELL Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Feeding Behavior

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Stephanie Manasse, Ph.D.

  Drexel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 20, 2024
• Study Start: April 18, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

US (1)