Family-Based Mindful Eating Intervention for Overweight Adolescents

NCT02114190 | Completed DMC

• 1 other identifier: 1R34AT007843-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Adolescent Behavior; Family Research; Weight Loss

Keywords

Overweight Adolescents; Mindful Eating and Living; Family Systems; Body-Mass Index; Mindfulness

Outcome Measures

Primary Outcomes (1)

• Change over time: adolescent weight

  Measurement of participant's weight

  Week 0, Week 8, Week 20

Secondary Outcomes (6)

• Change over time: markers of metabolic syndrome.

  Week 0, Week 8, Week 20

• Change over time: adolescent Body Mass Index

  Week 0, Week 8, Week 20

• Change over time: adolescent's eating behavior

  Week 0, Week 8, Week 20

• Change over time: markers of psychological distress

  Week 0, Week 8, Week 20

• Change over time: family barriers to healthy eating

  Week 0, Week 8, Week 20

Study Arms (2)

Adolescent Mindful Eating Group

EXPERIMENTAL

Adolescents will participate in a 8 week mindful eating programs tailored for adolescents.

Behavioral: Adolescent Mindful Eating Group

Parent Intergrated Group

EXPERIMENTAL

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

Interventions

Adolescent Mindful Eating Group BEHAVIORAL

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.

Adolescent Mindful Eating Group

Parent Integrated Group BEHAVIORAL

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.

Parent Intergrated Group

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Oregon Research Institute: lead

Study Sites (1)

ORI Center for Family and Adolescent Research

Albuquerque, New Mexico, 87102, United States

Location

MeSH Terms

Conditions

Overweight; Adolescent Behavior; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Body Weight Changes

Study Officials

• Jeanne Dalen, Ph.D

  Oregon Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 15, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: March 1, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

US (1)