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Completed

NCT Number: NCT03085160

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.

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Key information

Conditions

Obesity Adolescent Development Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado State University

Fort Collins, Colorado, 80523, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Learning to BREATHE

Behavioral

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

Health Education

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Registry information

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Mar 21, 2017
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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