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| ID | Type | Description | Link |
|---|---|---|---|
| R03DK138216 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Manasse, Ph.D. | Drexel University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drexel University WELL Center | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| From enrollment to the end of the study (approximately 4 months) |
| 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. | From enrollment to the end of the study (approximately 4 months) |
| 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. | From enrollment to the end of the study (approximately 4 months) |
| 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. | From enrollment to the end of the study (approximately 4 months) |
| Average bed 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 bed time will be calculated. | From enrollment to the end of the study (approximately 4 months) |
| Average sleep latency | 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. | From enrollment to the end of the study (approximately 4 months) |
| Average weekday-weekend bed time shift | 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. | From enrollment to the end of the study (approximately 4 months) |
| Pittsburgh Sleep Quality Index | Adolescents and their parents will complete the Pittsburgh Sleep Quality Index, a well-validated overall measure of sleep quality, at each assessment point. | From enrollment to the end of the study (approximately 4 months) |
| Morningness Eveningness Questionnaire | 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. | From enrollment to the end of the study (approximately 4 months) |
| Insomnia Severity Index | The investigators will have participants complete the Insomnia Severity Index to assess insomnia. | From enrollment to the end of the study (approximately 4 months) |
| Sleep - Fitbit data | Participants will wear a FitBit during the assessment weeks, which will gather accelerometry data on sleep. | From enrollment to the end of the study (approximately 4 months) |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001522 | Behavior, Animal |
| D001519 | Behavior |