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Mindfulness in Adolescents With Obesity

19. mars 2021 oppdatert av: Elizabeth Cotter, American University

Examining the Feasibility of a Brief Adjunctive Mindfulness Intervention for Adolescents With Obesity

The goal of this study is to conduct a single arm open trial to examine the feasibility of a brief, adjunctive mindfulness intervention tailored to the needs of adolescents with severe obesity.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The purpose of this study is to examine whether it is feasible to integrate a brief, adjunctive mindfulness intervention with the standard medical management of obesity in adolescents with severe obesity. Mindfulness refers to the experience of paying attention to the present moment in a nonjudgmental manner. Mindfulness training enhances one's ability to cope with negative emotions and one's awareness of decision-making processes and internal experiences.

The proposed study has two specific aims: 1) to conduct a single arm open trial to examine the feasibility and acceptability of the mindfulness intervention in a sample of 15 adolescents with severe obesity; and 2) to examine the preliminary efficacy of the mindfulness intervention on BMI, emotion regulation, eating and weight-related behaviors, impulsivity, waist circumference, and blood pressure in comparison to the standard of care.

Studietype

Intervensjonell

Registrering (Faktiske)

11

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20001
        • Children's National Medical Center - IDEAL Clinic

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 17 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • between the ages of 12 - 17 years
  • a current patient of our affiliated obesity clinic
  • have a body mass index (BMI) between 30 and 45 kg/m2.

Exclusion Criteria:

  • have a known genetic cause of obesity
  • have been diagnosed with a severe intellectual or learning disability
  • have been diagnosed with an autism spectrum disorder or current psychosis
  • are taking a medication intended to reduce body weight

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Mindfulness
The mindfulness intervention consists of 6 weekly sessions, blending material from the evidence-based Learning to BREATHE and Mindfulness-Based Eating Awareness Training manualized interventions. Sessions will focus on: experiential mindfulness exercises, such as mindful eating, loving kindness practices, breath awareness, and mindful movement; hunger and satiety awareness; improving responses to emotions; practicing acceptance and being non-judgmental; and tolerating negative feelings and sensations, including those related to hunger and cravings. Participants will be assigned brief homework exercises (approximately 10 minutes) daily in between appointments.Participants in this arm will also receive the usual care provided by the weight management clinic.
Atferdsmessig: Mindfulness
Mindfulness refers to the experience of paying attention to the present moment in a nonjudgmental manner. The mindfulness intervention consists of 6 weekly sessions focused on: experiential mindfulness exercises, such as mindful eating, loving kindness practices, breath awareness, and mindful movement; hunger and satiety awareness; improving responses to emotions; practicing acceptance and being non-judgmental; and tolerating negative feelings and sensations, including those related to hunger and cravings. Participants will be assigned brief homework exercises (approximately 10 minutes) daily in between appointments.
Atferdsmessig: Usual Care
Participants will receive the recommended standard of medical management of overweight and obesity. The clinic team conducts a comprehensive evaluation of the patient to assess dietary and activity behavior change needs of each patient and family, as well as obesity-associated comorbidities. In addition to management of comorbidities, goals for improved physical activity and dietary behaviors are set with the patient and family at each visit.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Sessions Attended by Participant
Tidsramme: 6 weeks post study start date
Retention will be tracked via attendance; research staff will take attendance during each assessment period and intervention session to determine the feasibility of retaining participants.
6 weeks post study start date
Participant Satisfaction: Satisfaction Survey
Tidsramme: 6 weeks post study start date
We will assess participants' satisfaction with the intervention by having them complete a satisfaction survey at the end of the program to assess perceived helpfulness of the intervention and to elicit feedback on the various components. Participants respond to 6 questions (e.g., "I enjoyed being a part of this program") on a scale of 1 (strongly disagree) to 5 (strongly agree). An average across scores will be calculated with higher scores reflecting greater satisfaction. Possible scores range from 1 to 5.
6 weeks post study start date

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Binge Eating - Eating Disorders Examination-Questionnaire (EDEQ).
Tidsramme: Change from Baseline to 6 weeks
Participants will report instances of binge eating via items of the Eating Disorders Examination-Questionnaire (EDEQ). Participants report how often they engaged in binge eating over the past 28 days 0 (no days) to 28 (every day). Higher scores represent greater eating pathology.
Change from Baseline to 6 weeks
Mindful Attention Awareness Scale-Adolescent (MAAS-A)
Tidsramme: Change from Baseline to 6 weeks
Participants rate how frequently they experience episodes of mindless behavior via the Mindful Attention Awareness Scale-Adolescent (MAAS-A). The MAAS-A is a 15-item measure of dispositional mindfulness. Participants respond to statements on a scale from 1 (almost always) to 6 (almost never). Items are summed with scores ranging from 15 to 90, with higher scores representing higher levels of mindfulness.
Change from Baseline to 6 weeks
"Go" Reaction Time - Measure of Inhibitory Control
Tidsramme: Change from Baseline to 6 weeks
The Go No Go Task examines inhibitory control via a computerized program. Participants are instructed to press a button when a certain image is shown on the screen (e.g., a green rectangle, a cross). They are instructed not to respond when another image is shown on the screen (e.g., a blue rectangle, an X). Poor inhibitory control is evident by more failures to inhibit responses in the "no go" condition. Reaction time is the processing speed for correct Go trials.
Change from Baseline to 6 weeks
Body Mass Index (BMI)
Tidsramme: Change from Baseline to 6 weeks
Height and weight will be assessed in order to calculate BMI.
Change from Baseline to 6 weeks
Overeating - Eating Disorders Examination-Questionnaire (EDEQ).
Tidsramme: Change from Baseline to 6 weeks
Participants report instances of overeating via items of the Eating Disorders Examination-Questionnaire (EDEQ). Participants report how often they engaged in overeating over the past 28 days 0 (no days) to 28 (every day). Higher scores represent greater overeating.
Change from Baseline to 6 weeks
Go No Go False Alarm Rate - Measure of Inhibitory Control
Tidsramme: Change from Baseline to 6 weeks
The Go No Go Task examines inhibitory control via a computerized program. Participants are instructed to press a button when a certain image is shown on the screen (e.g., a green rectangle, a cross). They are instructed not to respond when another image is shown on the screen (e.g., a blue rectangle, an X). Poor inhibitory control is evident by more failures to inhibit responses in the "no go" condition. The false alarm rate refers to incorrect No Go trials.
Change from Baseline to 6 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

American University

Samarbeidspartnere

Children's National Research Institute

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

19. februar 2019

Primær fullføring (Faktiske)

31. august 2019

Studiet fullført (Faktiske)

1. juni 2020

Datoer for studieregistrering

Først innsendt

7. mars 2019

Først innsendt som oppfylte QC-kriteriene

12. mars 2019

Først lagt ut (Faktiske)

14. mars 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. april 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CNMC Pro00011128

Plan for individuelle deltakerdata (IPD)

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Studerer et amerikansk FDA-regulert medikamentprodukt

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Nei

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