Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-30 @ 9:33 AM
Study NCT ID:
NCT03441594
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2018-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Psychological Mechanisms Linking Food Insecurity and Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'candice.myers@pbrc.edu', 'phone': '12257632849', 'title': 'Candice A. Myers', 'organization': 'Pennington Biomedical Research Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, which was a single study visit with an average of 1 hour and 30 minutes.', 'eventGroups': [{'id': 'EG000', 'title': 'Single Group', 'description': 'The study sample included a single group of 56 food secure and food insecure women and men aged 18 to 49 years with a BMI of 20.0 kg/m2 or greater.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Delay Discounting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Group', 'description': 'The study sample included a single group of 56 food secure and food insecure women and men aged 18 to 49 years with a BMI of 20.0 kg/m2 or greater.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.84', 'spread': '2.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, an average of 1 hour and 30 minutes at Study Visit 1', 'description': "Assessed via the 27-Item Monetary Choice Questionnaire, which measures bias toward smaller, immediate rewards versus larger, delayed rewards. This questionnaire presents participants with a set of 27 choices between smaller, immediate monetary rewards and larger, delayed monetary rewards. Participants who discount the value of the delayed rewards more steeply are considered to be more impulsive. An estimate of a participant's discounting rate (k) is calculated from the pattern of choices. Values of k range from 0.00016 (ln transformation -8.74) to 0.25 (ln transformation -1.39), with higher values indicating a greater preference for smaller, immediate rewards over larger, delayed rewards. K tends to be skewed, so a natural log (ln) transformation is utilized to approximate a normal distribution for statistical analyses.", 'unitOfMeasure': 'score on a scale (natural log)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Grit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Group', 'description': 'The study sample included a single group of 56 food secure and food insecure women and men aged 18 to 49 years with a BMI of 20.0 kg/m2 or greater.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.68', 'spread': '0.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, an average of 1 hour and 30 minutes at Study Visit 1', 'description': 'Assessed using the 8-item Short Grit Scale, which measures trait-level perseverance and passion for long-term goals. Scores range from 1 (not at all gritty) to 5 (extremely gritty).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Group', 'description': 'The study sample included a single group of 56 food secure and food insecure women and men aged 18 to 49 years with a BMI of 20.0 kg/m2 or greater.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Group', 'description': 'The study sample included a single group of 56 food secure and food insecure women and men aged 18 to 49 years with a BMI of 20.0 kg/m2 or greater.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.25', 'spread': '9.18', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'Caucasian or Asian American', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-08', 'size': 182199, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-16T13:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-28', 'studyFirstSubmitDate': '2018-01-26', 'resultsFirstSubmitDate': '2020-01-06', 'studyFirstSubmitQcDate': '2018-02-14', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-28', 'studyFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delay Discounting', 'timeFrame': 'Through study completion, an average of 1 hour and 30 minutes at Study Visit 1', 'description': "Assessed via the 27-Item Monetary Choice Questionnaire, which measures bias toward smaller, immediate rewards versus larger, delayed rewards. This questionnaire presents participants with a set of 27 choices between smaller, immediate monetary rewards and larger, delayed monetary rewards. Participants who discount the value of the delayed rewards more steeply are considered to be more impulsive. An estimate of a participant's discounting rate (k) is calculated from the pattern of choices. Values of k range from 0.00016 (ln transformation -8.74) to 0.25 (ln transformation -1.39), with higher values indicating a greater preference for smaller, immediate rewards over larger, delayed rewards. K tends to be skewed, so a natural log (ln) transformation is utilized to approximate a normal distribution for statistical analyses."}], 'secondaryOutcomes': [{'measure': 'Grit', 'timeFrame': 'Through study completion, an average of 1 hour and 30 minutes at Study Visit 1', 'description': 'Assessed using the 8-item Short Grit Scale, which measures trait-level perseverance and passion for long-term goals. Scores range from 1 (not at all gritty) to 5 (extremely gritty).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Food Insecurity'], 'conditions': ['Obesity', 'Psychological']}, 'referencesModule': {'references': [{'pmid': '32597739', 'type': 'DERIVED', 'citation': 'Myers CA, Beyl RA, Martin CK, Broyles ST, Katzmarzyk PT. Psychological mechanisms associated with food security status and BMI in adults: a mixed methods study. Public Health Nutr. 2020 Oct;23(14):2501-2511. doi: 10.1017/S1368980020000889. Epub 2020 Jun 29.'}]}, 'descriptionModule': {'briefSummary': 'The current pilot study will examine emergent hypotheses by investigating the role of psychological mechanisms in the relationship between food insecurity and obesity. This objective will be achieved via a cross-sectional, observational pilot study collecting quantitative and qualitative data.', 'detailedDescription': 'This pilot study will investigate an emergent risk factor for obesity: food insecurity, which is defined as the limited or uncertain availability of nutritionally adequate and safe foods. While paradoxically linked, numerous studies have shown a significant association between food insecurity and obesity. Moreover, recent narrative works have developed new, untested hypotheses linking food insecurity and obesity positing the causal role of psychological mechanisms. Given this, this mixed method pilot study will collect new psychological data in a sample of food secure and food insecure adults with and without obesity to examine the connections between food insecurity, body weight, and psychological constructs. The overarching objective of the study is to gather pilot data to identify potentially new intervention targets that will be used in future studies to more rigorously investigate the relationship between food insecurity and obesity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The target study sample will be 56 food secure and food insecure women and men aged 18 to 49 years with a BMI of 20.0 kg/m2 or greater.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-49 years\n* BMI ≥ 20.0 kg/m2\n* Able to read and write using the English language\n* Willing to provide written informed consent\n\nExclusion Criteria:\n\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03441594', 'briefTitle': 'Psychological Mechanisms Linking Food Insecurity and Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'Psychological Mechanisms Linking Food Insecurity and Obesity (Food Mind Pilot Study)', 'orgStudyIdInfo': {'id': '2017-060-PBRC'}, 'secondaryIdInfos': [{'id': 'U54GM104940', 'link': 'https://reporter.nih.gov/quickSearch/U54GM104940', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808-4124', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}], 'overallOfficials': [{'name': 'Candice A Myers, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedicial Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Candice A. Myers, Ph.D.', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}