ObesityNCT03085160
Project EAT: Eating and Attitudes in Teens
A study testing Learning to Breathe and Health Education in people with Obesity and Adolescent Development, run by Colorado State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Adolescent Development, Stress
- What is being tested?
- Learning to Breathe and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2014to 5 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University
Fort Collins, Colorado, 80523
About this study
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.
- Conditions
- Obesity, Adolescent Development, Stress
- Being tested
- Learning to Breathe, Health Education
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning to BreatheBehavioural
Six-session group program that involves meditation and interactive activities to learn mindfulness skills for coping with stress
Health EducationBehavioural
Six-session group program that covers topics important for healthy living such as avoiding drug use, conflict resolution, bullying, sun safety and others
| Study group | Role | What they receive |
|---|---|---|
| Learning to Breathe | Experimental | Six-week mindfulness-based group program for adolescents Receives: Behavioral: Learning to Breathe |
| Health Education | Active comparator | Six-week health education group program for adolescents Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of study
Rate of recruitment of eligible adolescent volunteers
Measured: 3 years
Acceptability of program
Session attendance determined as percentage of total sessions (6) attended
Measured: 6 weeks
Acceptability of study participation
Post-intervention acceptability ratings
Measured: 6 weeks
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 6 months
Meal intake
Measured laboratory test meal intake
Measured: 6 months
Weight gain
Gain in BMI (kg/m2) units
Measured: 6 months
Fat gain
Gain in body fat mass as measured by air displacement plethysmography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start27 Oct 2014
- Primary completion5 Dec 2020
- Study completion5 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085160
- Sponsor's protocol ID
- 14-5084
- Status last verified
- Feb 2021
- First submitted
- 9 Mar 2017
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project EAT: Eating and Attitudes in Teens
- ClinicalTrials.gov ID
- NCT03085160
- Acronym / sponsor ID
- 14-5084
- Conditions
- Obesity, Adolescent Development, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- 27 Oct 2014 (actual)
- Primary completion
- 5 Dec 2020 (actual)
- Study completion
- 5 Dec 2020 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Learning to Breathe | Experimental | Behavioral: Learning to BreatheSix-week mindfulness-based group program for adolescents |
| Health Education | Active comparator | Behavioral: Health EducationSix-week health education group program for adolescents |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Learning to BreatheSix-session group program that involves meditation and interactive activities to learn mindfulness skills for coping with stress | Behavioural | Learning to Breathe |
| Health EducationSix-session group program that covers topics important for healthy living such as avoiding drug use, conflict resolution, bullying, sun safety and others | Behavioural | Health Education |
Primary outcome
Feasibility of study
Time frame: 3 years
Rate of recruitment of eligible adolescent volunteers
Acceptability of program
Time frame: 6 weeks
Session attendance determined as percentage of total sessions (6) attended
Acceptability of study participation
Time frame: 6 weeks
Post-intervention acceptability ratings
6 secondary outcomes
Perceived stress
Time frame: 6 months
Executive function
Time frame: 6 months
Food reward sensitivity
Time frame: 6 months
Meal intake
Time frame: 6 months
Weight gain
Time frame: 6 months
Fat gain
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Derived from this study: PubMed 31112737Shomaker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Learning to Breathe and Health Education in people with Obesity and Adolescent Development, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of study (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03085160, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.