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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Indiana
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Indianapolis, Indiana, Förenta staterna, 46202
- Indiana University School of Medicine
-
Kontakt:
- Janet Lydecker, PhD
- Telefonnummer: 317-963-7288
- E-post: jalydeck@iu.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Andra namn:
|
|
Experimentell: 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.
Andra namn:
|
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Aktiv komparator: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Binge Eating Episode Frequency
Tidsram: End of treatment (6 months)
|
Eating episodes will be assessed by the Eating Disorder Examination |
End of treatment (6 months)
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|
Weight (e.g., Percent Loss)
Tidsram: End of treatment (6 months)
|
Percent body mass index change |
End of treatment (6 months)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Eating Disorder Severity
Tidsram: 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)
|
|
Weight-related Quality of Life score
Tidsram: End of treatment (6 months)
|
Weight-related quality of life will be assessed by questionnaire. |
End of treatment (6 months)
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Näringsstörningar
- Övernäring
- Kroppsvikt
- Hyperfagi
- Tecken och symtom, matsmältningssystemet
- Patologiska tillstånd, tecken och symtom
- Närings- och metabola sjukdomar
- Tecken och symtom
- Övervikt
- Bulimi
- Fetma
- Matnings- och ätstörningar
- Undersökningstekniker
- Terapeutik
- Kliniska laboratorietekniker
- Diagnostiska tekniker och procedurer
- Diagnos
- Beteendebehandling
- Psykoterapi
- Beteendediscipliner och aktiviteter
- Blodkemisk analys
- Klinisk kemi -test
- Diagnostiska tekniker, endokrin
- Övervakning, fysiologisk
- Självtestning
- Egenvård
- Kognitiv beteendeterapi
- Blodglukos självövervakning
Andra studie-ID-nummer
- 32948
- R01DK146817 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
de-identified data will be shared with qualified researchers with ethics board approval and a data use agreement.
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