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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Lifestyle Modification and Sleep Intervention
BehavioralThis 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Group InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percent of 95th percentile BMI
Height and weight will be measured at each assessment and used to calculate percent of 95th percentile BMI.
Time frame
From enrollment to the end of the study (approximately 4 months)2
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.
Time frame
From enrollment to the end of the study (approximately 4 months)3
Body fat percentage
Body fat percentage will also be derived from the Aria Air scale.
Time frame
From enrollment to the end of the study (approximately 4 months)Secondary outcomes
1
Dietary intake
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.
Time frame
From enrollment to the end of the study (approximately 4 months)2
Eating Disorder Examination
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.
Time frame
From enrollment to the end of the study (approximately 4 months)3
Eating Disorder Examination Questionnaire
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.
Time frame
From enrollment to the end of the study (approximately 4 months)4
Average total sleep time
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.
Time frame
From enrollment to the end of the study (approximately 4 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nemours Children's Clinic
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov