CClinicalTrials.gg
CompletedNCT03085160Updated Feb 4, 2021

Project EAT: Eating and Attitudes in Teens

An interventional study of Learning to Breathe and Health Education in Obesity, Adolescent Development and Stress, sponsored by Colorado State University. Completed at 1 site in United States. Open to participants aged 12 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-04.

Sponsored by Colorado State University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Oct 2014, registered Mar 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
12 Years to 17 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Obesity
  • Adolescent Development
  • Stress
03

In context

Lead sponsor

Colorado State University is the lead sponsor of 112 studies on the registry; 19 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Learning to Breathe

    Six-week mindfulness-based group program for adolescents

    Behavioral: Learning to Breathe

  • Active comparator
    Health Education

    Six-week health education group program for adolescents

    Behavioral: Health Education

Interventions

  • BehavioralLearning to Breathe

    Six-session group program that involves meditation and interactive activities to learn mindfulness skills for coping with stress

  • BehavioralHealth Education

    Six-session group program that covers topics important for healthy living such as avoiding drug use, conflict resolution, bullying, sun safety and others

06

What researchers measure

Primary outcomes

  1. Feasibility of study

    Rate of recruitment of eligible adolescent volunteers

    Time frame: 3 years

  2. Acceptability of program

    Session attendance determined as percentage of total sessions (6) attended

    Time frame: 6 weeks

  3. Acceptability of study participation

    Post-intervention acceptability ratings

    Time frame: 6 weeks

Secondary outcomes

  1. 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

    Time frame: 6 months

  2. 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

    Time frame: 6 months

  3. 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

    Time frame: 6 months

  4. Meal intake

    Measured laboratory test meal intake

    Time frame: 6 months

  5. Weight gain

    Gain in BMI (kg/m2) units

    Time frame: 6 months

  6. Fat gain

    Gain in body fat mass as measured by air displacement plethysmography

    Time frame: 6 months

07

Study locations

1 site
  • Colorado State University
    Fort Collins, Colorado 80523, United States
08

References and documents

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. PubMed 31112737 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03085160
Lead sponsor
Colorado State University
Responsible party
Sponsor
First posted
Mar 21, 2017
Start date
Oct 27, 2014
Primary completion
Dec 5, 2020
Completion
Dec 5, 2020
Last update
Feb 4, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion