Project EAT: Eating and Attitudes in Teens

Research suggests there is a connection between mood and weight. People who feel stressed or depressed are more likely to be overweight than people who don't have these feelings. Some individuals turn to food to cope, which can lead to gaining too much weight over time. Adolescence is an important time to understand these connections. Patterns of handling stress learned during adolescence set the stage for stress management in adulthood. This study is a randomized controlled pilot study with 60 adolescents who are at-risk for future, chronic obesity. The investigators will test if taking part in a 6-week group program to lower stress and improve mood will be helpful to teens at-risk.

Study Overview

• Status: Completed
• Conditions: Obesity; Stress; Adolescent Development
• Intervention / Treatment: Behavioral: Learning to Breathe; Behavioral: Health Education

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Fort Collins, Colorado, United States, 80523
      • Colorado State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 12-17 years
• At-risk for long-term obesity by virtue of current BMI (≥70th percentile for age and sex) or obesity (BMI ≥30 kg/m2) in both biological parents
• Good general health

Exclusion Criteria:

• Current full-syndrome psychiatric disorder that in the investigators' opinion would impede study compliance
• Major medical problem such as type 2 diabetes
• Use of medication affecting mood or body weight such as stimulants or anti-depressants
• Any medical issues that could be acutely worsened by exercise such as asthma or musculoskeletal problems.
• Pregnancy in females

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Learning to Breathe; Six-week mindfulness-based group program for adolescents	Behavioral: Learning to Breathe; Six-session group program that involves meditation and interactive activities to learn mindfulness skills for coping with stress
Active Comparator: Health Education; Six-week health education group program for adolescents	Behavioral: Health Education; Six-session group program that covers topics important for healthy living such as avoiding drug use, conflict resolution, bullying, sun safety and others

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of study	Rate of recruitment of eligible adolescent volunteers	3 years
Acceptability of program	Session attendance determined as percentage of total sessions (6) attended	6 weeks
Acceptability of study participation	Post-intervention acceptability ratings	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived stress	Changes in perceived stress as assessed by the 10-item version Perceived Stress Scale total score, computed as the sum of all items (range 0-40) with higher scores indicating greater perceived stress	6 months
Executive function	Executive function assessed with the parent version of the Behavior Rating Inventory of Everyday Executive Function, with 8 subscales computed as the sum of their respected items, including inhibit (range 0-20), shift (range 0-16), emotional control (range 0-20), initiate (range 0-16), working memory (range 0-20), planning/organization (range 0-24), organization of materials (range 0-12), and monitor (range 0-16). Higher scores reflect more problematic executive dysfunction	6 months
Food reward sensitivity	Relative reinforcing value of food assessed with behavioral task, with the outcome being the shift point when individuals shift from choosing a palatable food reward to an alternative reward (range 20-240) with higher scores reflecting greater sensitivity to food as a reward	6 months
Meal intake	Measured laboratory test meal intake	6 months
Weight gain	Gain in BMI (kg/m2) units	6 months
Fat gain	Gain in body fat mass as measured by air displacement plethysmography	6 months

Collaborators and Investigators

• Sponsor: Colorado State University

Publications and helpful links

General Publications

• Shomaker LB, Berman Z, Burke M, Annameier SK, Pivarunas B, Sanchez N, Smith AD, Hendrich S, Riggs NR, Legget KT, Cornier MA, Melby C, Johnson SA, Lucas-Thompson R. Mindfulness-based group intervention in adolescents at-risk for excess weight gain: A randomized controlled pilot study. Appetite. 2019 Sep 1;140:213-222. doi: 10.1016/j.appet.2019.05.022. Epub 2019 May 18.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2014
• Primary Completion (Actual): December 5, 2020
• Study Completion (Actual): December 5, 2020

Study Registration Dates

• First Submitted: March 9, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 14-5084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No