Mindfulness in Adolescents With Obesity

NCT03874377 | Completed Results

• 1 other identifier: CNMC Pro00011128
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mindfulness; Usual Care

Outcome Measures

Primary Outcomes (2)

• Number of Sessions Attended by Participant

  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

  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

Secondary Outcomes (6)

• Binge Eating - Eating Disorders Examination-Questionnaire (EDEQ).

  Change from Baseline to 6 weeks

• Mindful Attention Awareness Scale-Adolescent (MAAS-A)

  Change from Baseline to 6 weeks

• "Go" Reaction Time - Measure of Inhibitory Control

  Change from Baseline to 6 weeks

• Body Mass Index (BMI)

  Change from Baseline to 6 weeks

• Overeating - Eating Disorders Examination-Questionnaire (EDEQ).

  Change from Baseline to 6 weeks

Study Arms (1)

Mindfulness

EXPERIMENTAL

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.

Behavioral: Mindfulness; Behavioral: Usual Care

Interventions

Mindfulness BEHAVIORAL

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.

Mindfulness

Usual Care BEHAVIORAL

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.

Mindfulness

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• American University: lead
• Children's National Research Institute: collaborator

Study Sites (1)

Children's National Medical Center - IDEAL Clinic

Washington D.C., District of Columbia, 20001, United States

Location

Related Publications (1)

• Cotter EW, Hornack SE, Fotang JP, Pettit E, Mirza NM. A pilot open-label feasibility trial examining an adjunctive mindfulness intervention for adolescents with obesity. Pilot Feasibility Stud. 2020 Jun 6;6:79. doi: 10.1186/s40814-020-00621-1. eCollection 2020.

  PMID: 32518670 DERIVED

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Sarah Hornack
• Organization: Children's National Medical Center

shornack@childrensnational.org

202-895-3860

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 14, 2019
• Study Start: February 19, 2019
• Primary Completion: August 31, 2019
• Study Completion: June 1, 2020
• Last Updated: April 14, 2021
• Results First Posted: April 14, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)