Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (Online) (CARE2)
Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (CARE2)
This study will compare a psychological treatment (cognitive-behavioral therapy; CBT-BED) and a lifestyle beahvioral obesity intervention (LBOI) for adolescents who experience binge eating and have overweight or obesity. These treatments will be compared to each other and to a control condition that involves self-monitoring eating and mood using an "app". Participants can be located in most states in the United States. All participation occurs remotely by telehealth. The goal is to learn which approach works best for reducing binge eating and excess weight in this age group.
Přehled studie
Postavení
Detailní popis
Binge eating is the most prevalent eating disorder but has the lowest rate (<4%) of receiving eating disorder treatment. Binge eating often begins in adolescence and is related to obesity, physical and mental health problems, and psychological distress. Yet, there are virtually no established treatments, and no clear standard of care, for adolescents with binge eating. Evidence-based treatments exist for adults, including psychological treatments (e.g., CBT-BED) and lifestyle behavioral obesity intervention (LBOI), but how well these treatments work for adolescents remains largely unknown. LBOI is an effective treatment for adolescent obesity, but has only been tested as additional outcomes (not the initial goal) for binge eating. There is an urgent need for research to establish the efficacy of interventions for adolescents with binge eating to improve adolescents' health and quality of life. This study will conduct a randomized controlled trial (RCT) in which adolescents are randomized to Psychological Treatment (cognitive behavioral therapy for binge eating, or CBT-BED), Behavioral Treatment (lifestyle health behavioral treatment for obesity, or LBOI), or Active Control. In this study, we will compare both CBT-BED and LBOI to each other and to an Active Control. Active Control is daily self-monitoring (emotions, eating, exercise) on an "app", mimicking real-world self-help, followed by choice of CBT-BED or LBOI.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Indiana
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Indianapolis, Indiana, Spojené státy, 46202
- Indiana University School of Medicine
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Kontakt:
- Janet Lydecker, PhD
- Telefonní číslo: 317-963-7288
- E-mail: jalydeck@iu.edu
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Be in the age range ≥12 years old and ≤17 years old;
- Have a BMI that places them above the 85th percentile based on their age and sex;
- Report 4 episodes of binge eating (feeling a loss of control while eating) per month for the past 3 months;
- Be available for participation in the study for 18 months.
Exclusion Criteria:
- Have a medical or psychiatric condition that would require a higher level of care, such as hospitalization or intensive outpatient care (e.g., neurological disorder, psychotic disorders, suicidality);
- Have a medical or psychiatric condition that would prohibit them from engaging in behavioral treatment or moderate physical activity (e.g., cardiovascular problems);
- Have uncontrolled medical condition(s) (e.g., uncontrolled diabetes or hypertension);
- Be pregnant or breastfeeding;
- Be taking medication(s) or participating in treatment(s) that could influence weight or appetite;
- Have begun taking hormonal contraceptives less than 3 months prior, as this can be related to weight changes;
- Have a developmental or cognitive disorder that would interfere with engaging in cognitive treatment;
- Have a concurrent feeding/eating disorder (e.g., bulimia nervosa); or
- Be participating in another clinical research study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Cognitive-Behavioral Therapy
Cognitive-behavioral therapy for binge-eating disorder (CBT-BED) for adolescents with binge eating and overweight or obesity, delivered remotely by telehealth. |
Cognitive-behavioral therapy for binge-eating disorder (CBT-BED) for adolescents with binge eating and overweight or obesity, delivered remotely by telehealth. Sessions target cognitive and emotional drivers of binge eating through coping skills, problem-solving triggers, cognitive restructuring, and executive-function skill training; parent sessions focus on communication and support.
Ostatní jména:
|
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Experimentální: Lifestyle Behavioral Obesity Intervention
Lifestyle behavioral obesity intervention (LBOI) for adolescents with binge eating and overweight or obesity, delivered remotely by telehealth. |
Lifestyle behavioral obesity intervention (LBOI) for adolescents with binge eating and overweight or obesity, delivered remotely by telehealth. Sessions provide nutrition and physical-activity prescriptions to create a modest calorie deficit and sustainable lifestyle habits and problem-solve nonadherence; parent sessions focus on the home food environment.
Ostatní jména:
|
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Aktivní komparátor: Active Control
Active control: daily self-monitoring of eating, emotions, and physical activity via an "app," similar to real-world digital self-help. At the end of the initial period, individuals are presented with descriptions of CBT-BED and LBOI, choose their preferred treatment, and receive it. |
Self-monitoring eating, emotions, and exercise daily in a digital "app" that is similar to real-world self-help.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Binge Eating Episode Frequency
Časové okno: End of treatment (6 months)
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Eating episodes will be assessed by the Eating Disorder Examination |
End of treatment (6 months)
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Weight (e.g., Percent Loss)
Časové okno: End of treatment (6 months)
|
Percent body mass index change |
End of treatment (6 months)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Eating Disorder Severity
Časové okno: End of treatment (6 months)
|
Global eating-disorder psychopathology will be assessed by the Eating Disorder Examination (scores range from 0 through 6; higher scores indicate more severe psychopathology). |
End of treatment (6 months)
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Weight-related Quality of Life score
Časové okno: End of treatment (6 months)
|
Weight-related quality of life will be assessed by questionnaire. |
End of treatment (6 months)
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Duševní poruchy
- Poruchy výživy
- Nadměrná výživa
- Tělesná hmotnost
- Hyperfagie
- Příznaky a symptomy, zažívací
- Patologické stavy, příznaky a symptomy
- Nutriční a metabolické nemoci
- Příznaky a symptomy
- Nadváha
- Bulimie
- Obezita
- Poruchy krmení a příjmu potravy
- Vyšetřovací techniky
- Terapeutika
- Klinické laboratorní techniky
- Diagnostické techniky a postupy
- Diagnóza
- Terapie chování
- Psychoterapie
- Disciplíny a činnosti chování
- Chemická analýza krve
- Testy klinické chemie
- Diagnostické techniky, endokrinní
- Monitorování, fyziologické
- Samoobslužné testování
- Péče o sebe
- Kognitivní behaviorální terapie
- Krelodní glukóza samo monitorování
Další identifikační čísla studie
- 32948
- R01DK146817 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
de-identified data will be shared with qualified researchers with ethics board approval and a data use agreement.
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