Mindfulness Training to Promote Healthy Diet and Physical Activity in Teens

NCT01975896 | Completed DMC

• 1 other identifier: R21H119665
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This project will compare the preliminary efficacy of a novel school-delivered intervention, mindfulness plus health education intervention, to health education alone on dietary and physical activity habits in adolescents. This study has important public health implications because of the negative consequences of unhealthy diets and lack of exercise on health, such as obesity, cardiovascular disease and diabetes. If effective, this intervention has high potential for translation to high school settings

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (2)

• Feasibility of the Intervention

  We will be able to recruit 80 adolescents (40 per condition) within the specified time frame, and no more than 20% will drop out of the study.

  One academic year, 8 months

• Acceptability of Intervention

  Program evaluations for both conditions will show overall positive comments and at least 80% of participants will indicate high acceptability ratings.

  One academic year, 8 months

Secondary Outcomes (2)

• Preliminary estimates of efficacy

  One academic year, 8 months

• Explore possible mechanisms of the effect of MHE on diet and physical activity

  One academic year, 8 months

Study Arms (2)

Meditation

EXPERIMENTAL

The intervention's curriculum will include: 1) the body scan; 2) training in the awareness of the sensations of breathing; 3) training in directing the attention to simple activities of daily life; 4) practice of 'open awareness' in which students will be instructed to just notice which events (physical sensation, sound, visual object, thought) their attention is spontaneously drawn to from moment to moment; 5) mindful movement (standing and walking exercises); and 6) mindful eating. In addition to the weekly training session, students will practice mindfulness techniques for 15 minutes daily in class with the health education teacher and for an additional 15 minutes daily on their own

Behavioral: Meditation

Health Education

NO INTERVENTION

The health education curriculum will be informed by: 1) the dietary and PA didactic units and materials developed as part of our school based trial, adapted for adolescents from the Diabetes Prevention Program (DPP) and 2) the standard curricula for school-based health education programs with particular attention to the unique needs of adolescents:increasing fruits and vegetables, reducing sugar sweetened drinks, and decreasing foods high in fat, unhealthy carbohydrates, and calories. The PA component will be based on current recommendations of engaging in at least 1 hour of moderate-to-vigorous physical activity (MVPA) most days of the week, building PA into the teen's lifestyle,and reducing sedentary behavior.

Interventions

Meditation BEHAVIORAL

The intervention's curriculum will include: 1) the body scan; 2) training in the awareness of the sensations of breathing; 3) training in directing the attention to simple activities of daily life; 4) practice of 'open awareness' in which students will be instructed to just notice which events (physical sensation, sound, visual object, thought) their attention is spontaneously drawn to from moment to moment; 5) mindful movement (standing and walking exercises); and 6) mindful eating. In addition to the weekly training session, students will practice mindfulness techniques for 15 minutes daily in class with the health education teacher and for an additional 15 minutes daily on their own

Meditation

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Meditation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Elena Salmoirago-Blotcher, PhD, MD

  Brown University, Providence, RI

  PRINCIPAL INVESTIGATOR

• Lori Pbert, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 5, 2013
• Study Start: September 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

US (1)