Trial record 4 of 561 for:    Open Studies | "Family"

Family-Based Mindful Eating Intervention for Overweight Adolescents

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Oregon Research Institute
Sponsor:
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT02114190
First received: April 1, 2014
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

With currently 35% of U.S. adolescents being overweight and one in six having metabolic syndrome, adolescent obesity is one of the major global health challenges of the 21st century. Few enduring treatment strategies have been identified in adolescent populations and the majority of standard weight loss programs fail to adequately address the impact of psychological factors on eating behavior and the beneficial contribution of parental involvement in adolescent behavior change. A critical need exists to expand treatment development efforts beyond traditional education and cognitive-behavioral programs and to explore alternative treatment models for adolescent obesity. Meditation-based mindful eating programs may represent a unique and novel scientific approach to the current adolescent obesity epidemic as they address key psychological variables affecting weight. Furthermore, the recent expansion of mindfulness programs to include family relationships shows the immense potential for broadening the customarily individual focus of this intervention to include broader factors thought to influence adolescent health outcomes. Thus, we propose to develop a mindful eating approach to eating behavior and weight loss specifically tailored for adolescents and their families. The first phase of our three phase development process will be devoted to adapting an adolescent protocol (Mindful Eating-A) based on an established mindful eating program currently being used with adult populations. We will then develop a 'family enhanced Mindful Eating-A' (Mindful Eating-A+F) protocol that integrates a family systems perspective. The goal of Mindful Eating-A+F is to expand the focus of Mindful Eating-A to include family factors that influence adolescent eating behaviors. The second design phase will consist of an initial test of both intervention components to provide feedback on usefulness and acceptability (N = 10 families). The final phase will examine the overall efficacy of the optimized Mindful Eating-A+F, relative to the Mindful Eating-A intervention with 30 overweight adolescents (BMI > 85th percentile) ages 14-17 and at least one parent. Within this examination, post-treatment and 3-month follow-up comparisons across the two treatment approaches will be made and effect sizes within and between treatments will be assessed.


Condition Intervention
Overweight
Adolescent Behavior
Family Research
Weight Loss
Behavioral: Adolescent Mindful Eating Group
Behavioral: Parent Integrated Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adaptation and Evaluation of a Family-Based Mindful Eating Intervention for Overweight Adolescents

Resource links provided by NLM:


Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • Change over time: adolescent weight [ Time Frame: Week 0, Week 8, Week 20 ] [ Designated as safety issue: No ]
    Measurement of participant's weight


Secondary Outcome Measures:
  • Change over time: markers of metabolic syndrome. [ Time Frame: Week 0, Week 8, Week 20 ] [ Designated as safety issue: No ]
    Measurement of metabolic syndrome (insulin resistance, blood pressure, and dyslipidemia)

  • Change over time: adolescent Body Mass Index [ Time Frame: Week 0, Week 8, Week 20 ] [ Designated as safety issue: No ]
    Measurement of participant's Body Mass Index

  • Change over time: adolescent's eating behavior [ Time Frame: Week 0, Week 8, Week 20 ] [ Designated as safety issue: No ]
    Measurement of participant's eating behaviors

  • Change over time: markers of psychological distress [ Time Frame: Week 0, Week 8, Week 20 ] [ Designated as safety issue: No ]
    Measurement of psychological distress

  • Change over time: family barriers to healthy eating [ Time Frame: Week 0, Week 8, Week 20 ] [ Designated as safety issue: No ]
    Measurement of family barriers to healthy eating

  • Change over time: practice of mindfulness [ Time Frame: Week 0, Week 8, Week 20 ] [ Designated as safety issue: No ]
    Measurement of participant's practice of mindfulness


Estimated Enrollment: 120
Study Start Date: April 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adolescent Mindful Eating Group
Adolescents will participate in a 8 week mindful eating programs tailored for adolescents.
Behavioral: Adolescent Mindful Eating Group
Adolescents will learn mindfulness and meditation, how to be mindful when eating, mindful yoga, how to recognize hunger cures, understand emotional eating, trigger foods and how to apply mindful eating in social situations.
Experimental: Parent Intergrated Group
This intervention incorporates a family systems perspective into mindful eating interventions for adolescents. This intervention will consist of 11 sessions in an 8 week period, with sessions 2,7, and 11 incorporating family sessions. The purpose of the family sessions are to increase overall family motivation for behavior change, involve family members in identifying specific targets of change and establishing agreed upon strategies.
Behavioral: Parent Integrated Group
Adolescents will receive learn same techniques as adolescents in Adolescent Mindful Eating Group. The group component of the parent intervention is designed for parents only and will be run parallel to the adolescent group. The goal of these sessions is to teach parents skills to support adolescent by developing effective parenting styles, parenting skills, strategies around eating behavior change, productive problem solving, and the role of all other family members with regard to the treatment process. The last five sessions will be dedicated to teaching a slightly reduced MEAL adult protocol to allow parents to learn mindfulness skills as it applies to their own eating behaviors and affective reactivity.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adolescent ages 14-17 years old living at home with at least one parent/guardian,
  • BMI ≥ 85th percentile,
  • assent from adolescent,
  • consent from a parent/guardian,
  • willingness of one parent/guardian living with adolescent to participate in the study,
  • English speaking.

Exclusion Criteria:

  • Adolescent BMI ≥ 40 (requires additional medical attention the intervention is unable to provide),
  • previously diagnosed type 1 or type 2 diabetes,
  • blood pressure in the range of stage 2 hypertension which requires medication
  • treatment which interferes with outcomes related to blood pressure and glucose,
  • medications that significantly interfere with weight gain such as oral steroid use greater than two consecutive weeks
  • antipsychotic medications,
  • participation in a standardized weight loss program within the previous 6 months,
  • inability to provide informed assent,
  • no parent/guardian consent,
  • insufficient reading ability to comprehend the self-administered assessment instruments (approximately 5th grade reading level).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02114190

Contacts
Contact: Donna Sedillo, M.S. 505-263-7318 donnas@ori.org

Locations
United States, New Mexico
ORI Center for Family and Adolescent Research Not yet recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Janet Brody, PhD    505-842-8932    jbrody@ori.org   
Sub-Investigator: Janet Brody, PhD         
Sponsors and Collaborators
Oregon Research Institute
Investigators
Principal Investigator: Jeanne Dalen, Ph.D Oregon Research Institute
  More Information

No publications provided

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT02114190     History of Changes
Other Study ID Numbers: 1R34AT007843-01
Study First Received: April 1, 2014
Last Updated: April 21, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by Oregon Research Institute:
Overweight Adolescents
Mindful Eating and Living
Family Systems
Body-Mass Index
Mindfulness

Additional relevant MeSH terms:
Weight Loss
Overweight
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014