Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-02-25 @ 4:38 PM
Study NCT ID:
NCT03085160
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2017-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Project EAT: Eating and Attitudes in Teens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2017-03-09', 'studyFirstSubmitQcDate': '2017-03-14', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of study', 'timeFrame': '3 years', 'description': 'Rate of recruitment of eligible adolescent volunteers'}, {'measure': 'Acceptability of program', 'timeFrame': '6 weeks', 'description': 'Session attendance determined as percentage of total sessions (6) attended'}, {'measure': 'Acceptability of study participation', 'timeFrame': '6 weeks', 'description': 'Post-intervention acceptability ratings'}], 'secondaryOutcomes': [{'measure': 'Perceived stress', 'timeFrame': '6 months', 'description': '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'}, {'measure': 'Executive function', 'timeFrame': '6 months', 'description': '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'}, {'measure': 'Food reward sensitivity', 'timeFrame': '6 months', 'description': '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'}, {'measure': 'Meal intake', 'timeFrame': '6 months', 'description': 'Measured laboratory test meal intake'}, {'measure': 'Weight gain', 'timeFrame': '6 months', 'description': 'Gain in BMI (kg/m2) units'}, {'measure': 'Fat gain', 'timeFrame': '6 months', 'description': 'Gain in body fat mass as measured by air displacement plethysmography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Adolescent Development', 'Stress']}, 'referencesModule': {'references': [{'pmid': '31112737', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 12-17 years\n* 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\n* Good general health\n\nExclusion Criteria:\n\n* Current full-syndrome psychiatric disorder that in the investigators' opinion would impede study compliance\n* Major medical problem such as type 2 diabetes\n* Use of medication affecting mood or body weight such as stimulants or anti-depressants\n* Any medical issues that could be acutely worsened by exercise such as asthma or musculoskeletal problems.\n* Pregnancy in females"}, 'identificationModule': {'nctId': 'NCT03085160', 'briefTitle': 'Project EAT: Eating and Attitudes in Teens', 'organization': {'class': 'OTHER', 'fullName': 'Colorado State University'}, 'officialTitle': 'Project EAT: Eating and Attitudes in Teens', 'orgStudyIdInfo': {'id': '14-5084'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Learning to Breathe', 'description': 'Six-week mindfulness-based group program for adolescents', 'interventionNames': ['Behavioral: Learning to Breathe']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health Education', 'description': 'Six-week health education group program for adolescents', 'interventionNames': ['Behavioral: Health Education']}], 'interventions': [{'name': 'Learning to Breathe', 'type': 'BEHAVIORAL', 'description': 'Six-session group program that involves meditation and interactive activities to learn mindfulness skills for coping with stress', 'armGroupLabels': ['Learning to Breathe']}, {'name': 'Health Education', 'type': 'BEHAVIORAL', 'description': 'Six-session group program that covers topics important for healthy living such as avoiding drug use, conflict resolution, bullying, sun safety and others', 'armGroupLabels': ['Health Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80523', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado State University', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colorado State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}