Family-Based Mindful Eating Intervention for Overweight Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02114190
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):
Oregon Research Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Overweight Adolescent Behavior Family Research Weight Loss Behavioral: Adolescent Mindful Eating Group Behavioral: Parent Integrated Group Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adaptation and Evaluation of a Family-Based Mindful Eating Intervention for Overweight Adolescents
Study Start Date : April 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Change over time: adolescent weight [ Time Frame: Week 0, Week 8, Week 20 ]
    Measurement of participant's weight

Secondary Outcome Measures :
  1. Change over time: markers of metabolic syndrome. [ Time Frame: Week 0, Week 8, Week 20 ]
    Measurement of metabolic syndrome (insulin resistance, blood pressure, and dyslipidemia)

  2. Change over time: adolescent Body Mass Index [ Time Frame: Week 0, Week 8, Week 20 ]
    Measurement of participant's Body Mass Index

  3. Change over time: adolescent's eating behavior [ Time Frame: Week 0, Week 8, Week 20 ]
    Measurement of participant's eating behaviors

  4. Change over time: markers of psychological distress [ Time Frame: Week 0, Week 8, Week 20 ]
    Measurement of psychological distress

  5. Change over time: family barriers to healthy eating [ Time Frame: Week 0, Week 8, Week 20 ]
    Measurement of family barriers to healthy eating

  6. Change over time: practice of mindfulness [ Time Frame: Week 0, Week 8, Week 20 ]
    Measurement of participant's practice of mindfulness

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02114190

United States, New Mexico
ORI Center for Family and Adolescent Research
Albuquerque, New Mexico, United States, 87102
Sponsors and Collaborators
Oregon Research Institute
Principal Investigator: Jeanne Dalen, Ph.D Oregon Research Institute

Responsible Party: Oregon Research Institute Identifier: NCT02114190     History of Changes
Other Study ID Numbers: 1R34AT007843-01 ( U.S. NIH Grant/Contract )
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

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

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