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NCT Number: NCT06745570

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

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.

Recruiting

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Key information

Conditions

Adolescent Overweight Adolescent Obesity Behavior Behavior, Animal Body Weight Dietary Intake Eating Behaviors Feeding Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Sleep

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemours Children's Clinic

Wilmington, Delaware, 19803, United States

Location status: Recruiting

Location contact

Stephanie Manasse, Ph.D.

CONTACT

[email protected]

(215) 553-7500

About this study

In this study, the investigators will develop, refine, and test a 16-session group-based lifestyle modification intervention for adolescents with overweight and obesity augmented with a sleep intervention. The investigators will develop the manual and pilot the intervention in an initial set of adolescents (n=10). The investigators will collect feedback from adolescents, parents, and clinicians, which will inform manual refinements. The investigators will complete an open trial (n=40) of the refined manual. For both phases, the investigators will recruit adolescents (ages 14-18) with overweight or obesity who endorse at least 1 type of sleep disturbance (i.e., too little, poor quality, poorly timed, or inconsistent sleep). Assessments of sleep, decision-making, problematic eating behaviors, energy intake, and weight will occur at baseline (week 0), mid-intervention (week 8) and post-intervention (week 16).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. Percent of 95th percentile BMI

    Time frame: From 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.

  2. Tri-ponderal mass index

    Time frame: From 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.

  3. Body fat percentage

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

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

Secondary outcomes

  1. Dietary intake

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

    Adolescent dietary intake will be assessed via 30-day dietary recalls using the VioScreen at the baseline and post-treatment assessments. This freely available and validated web-based tool enables automated, self-administered, 30-day recalls. The VioScreen provides item-level nutritional information as well as monthly totals of key nutrient variables. Mean intake of the following food/macronutrient groups will be calculated: fruits and vegetables, fat, saturated fat, protein, cholesterol, added sugars, and dietary fiber.

  2. Eating Disorder Examination

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

    The investigators will also assess adolescent eating behaviors using the Binge Module and the Compensatory Behaviors Module portions of the Eating Disorder Examination at each assessment point.

  3. Eating Disorder Examination Questionnaire

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

    The investigators will have adolescents and their parents complete the Eating Disorder Examination Questionnaire, a self-report measure of eating behaviors, and baseline and post-treatment.

  4. Average total sleep time

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

    Adolescent sleep diaries will be collected for a 1-week period prior to the initiation of the intervention, 1 week at mid-intervention and 1 week following the intervention. Average total sleep time will be calculated.

  5. Average bed time

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

    Adolescent sleep diaries will be collected for a 1-week period prior to the initiation of the intervention, 1 week at mid-intervention and 1 week following the intervention. Average bed time will be calculated.

  6. Average sleep latency

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

    Adolescent sleep diaries will be collected for a 1-week period prior to the initiation of the intervention, 1 week at mid-intervention and 1 week following the intervention. Average sleep latency will be calculated.

  7. Average weekday-weekend bed time shift

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

    Adolescent sleep diaries will be collected for a 1-week period prior to the initiation of the intervention, 1 week at mid-intervention and 1 week following the intervention. Average weekday-weekend bed time shift will be calculated.

  8. Pittsburgh Sleep Quality Index

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

    Adolescents and their parents will complete the Pittsburgh Sleep Quality Index, a well-validated overall measure of sleep quality, at each assessment point.

  9. Morningness Eveningness Questionnaire

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

    The investigators will use the Morningness Eveningness Questionnaire at each assessment point to assess differences in the degree to which adolescents are active and alert at certain times of the day.

  10. Insomnia Severity Index

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

    The investigators will have participants complete the Insomnia Severity Index to assess insomnia.

  11. Sleep - Fitbit data

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

    Participants will wear a FitBit during the assessment weeks, which will gather accelerometry data on sleep.

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Manasse, Ph.D

CONTACT

[email protected]

3022988390

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Improving Sleep as a Method for Enhancing Decision-Making and Reducing Problematic Eating Behaviors in Adolescents With Obesity

Acronym: STAR

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 20, 2024
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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