Project EAT: Eating and Attitudes in Teens

Obesity Clinical Trial

Official title:

Project EAT: Eating and Attitudes in Teens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03085160
• Other study ID #: 14-5084
• Status: Completed
• Phase: N/A
• Start date: October 27, 2014
• Est. completion date: December 5, 2020

Study information

• Verified date: February 2021
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 5, 2020
• Est. primary completion date: December 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Development
• Obesity
• Stress

Intervention

Behavioral:
• Learning to Breathe
Six-session group program that involves meditation and interactive activities to learn mindfulness skills for coping with stress
• 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

Locations

Country	Name	City	State
United States	Colorado State University	Fort Collins	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Colorado State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of study	Rate of recruitment of eligible adolescent volunteers	3 years
Primary	Acceptability of program	Session attendance determined as percentage of total sessions (6) attended	6 weeks
Primary	Acceptability of study participation	Post-intervention acceptability ratings	6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Meal intake	Measured laboratory test meal intake	6 months
Secondary	Weight gain	Gain in BMI (kg/m2) units	6 months
Secondary	Fat gain	Gain in body fat mass as measured by air displacement plethysmography	6 months