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Project EAT: Eating and Attitudes in Teens

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.
 
ClinicalTrials.gov Identifier: NCT03085160
Recruitment Status : Completed
First Posted : March 21, 2017
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Colorado State University

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Adolescent Development Stress Behavioral: Learning to Breathe Behavioral: Health Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Project EAT: Eating and Attitudes in Teens
Actual Study Start Date : October 27, 2014
Actual Primary Completion Date : December 5, 2020
Actual Study Completion Date : December 5, 2020

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




Primary Outcome Measures :
  1. Feasibility of study [ Time Frame: 3 years ]
    Rate of recruitment of eligible adolescent volunteers

  2. Acceptability of program [ Time Frame: 6 weeks ]
    Session attendance determined as percentage of total sessions (6) attended

  3. Acceptability of study participation [ Time Frame: 6 weeks ]
    Post-intervention acceptability ratings


Secondary Outcome Measures :
  1. Perceived stress [ Time Frame: 6 months ]
    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

  2. Executive function [ Time Frame: 6 months ]
    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

  3. Food reward sensitivity [ Time Frame: 6 months ]
    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

  4. Meal intake [ Time Frame: 6 months ]
    Measured laboratory test meal intake

  5. Weight gain [ Time Frame: 6 months ]
    Gain in BMI (kg/m2) units

  6. Fat gain [ Time Frame: 6 months ]
    Gain in body fat mass as measured by air displacement plethysmography



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT03085160


Locations
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United States, Colorado
Colorado State University
Fort Collins, Colorado, United States, 80523
Sponsors and Collaborators
Colorado State University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Colorado State University
ClinicalTrials.gov Identifier: NCT03085160    
Other Study ID Numbers: 14-5084
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No