Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 5:30 AM
Study NCT ID:
NCT00837694
Status:
COMPLETED
Last Update Posted:
2019-08-01
First Post:
2009-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Snack Food Reinforcement in Obese and Non-obese Women
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': 'jltemple@buffalo.edu', 'phone': '716-829-5593', 'title': 'Jennifer L. Temple', 'organization': 'University at Buffalo'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'One limitation was that we relied on self-report for energy and snack food intake. It is possible that people were not eating the food that they said they were. Another limitation was that people may have not understood the task.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Non-Obese/0 kcal', 'description': 'Non-obese participants that received no snack food to consume for two weeks.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-Obese/100 kcal', 'description': 'Non-obese participants that received a 100 kcal portion of food to consume daily for two weeks.', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Non-obese/300 kcal', 'description': 'Non-obese participants that received a 300 kcal portion of food to consume daily for two weeks.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Obese/0 kcal', 'description': 'Obese participants that received no food to consume for two weeks.', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Obese/100 kcal', 'description': 'Obese participants that received a 100 kcal portion of food to consume daily for two weeks.', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Obese/300 kcal', 'description': 'Obese individuals who received a 300 kcal portion of food to consume for 2 weeks.', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Responses Made by Clicking a Mouse Button for Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Obese/0 kcal', 'description': 'Non-obese participants that received no snack food to consume for two weeks.'}, {'id': 'OG001', 'title': 'Non-Obese/100 kcal', 'description': 'Non-obese participants that received a 100 kcal portion of food to consume daily for two weeks.'}, {'id': 'OG002', 'title': 'Non-obese/300 kcal', 'description': 'Non-obese participants that received a 300 kcal portion of food to consume daily for two weeks.'}, {'id': 'OG003', 'title': 'Obese/0 kcal', 'description': 'Obese participants that received no food to consume for two weeks.'}, {'id': 'OG004', 'title': 'Obese/100 kcal', 'description': 'Obese participants that received a 100 kcal portion of food to consume daily for two weeks.'}, {'id': 'OG005', 'title': 'Obese/300 kcal', 'description': 'Obese individuals who received a 300 kcal portion of food to consume for 2 weeks.'}], 'classes': [{'title': 'Number of responses at baseline', 'categories': [{'measurements': [{'value': '397.63', 'spread': '307.6', 'groupId': 'OG000'}, {'value': '288.36', 'spread': '68.44', 'groupId': 'OG001'}, {'value': '429.5', 'spread': '307.7', 'groupId': 'OG002'}, {'value': '213.2', 'spread': '72.51', 'groupId': 'OG003'}, {'value': '448.36', 'spread': '217.49', 'groupId': 'OG004'}, {'value': '502.00', 'spread': '257.05', 'groupId': 'OG005'}]}]}, {'title': 'Number of responses visit 3', 'categories': [{'measurements': [{'value': '170.38', 'spread': '77.48', 'groupId': 'OG000'}, {'value': '227.27', 'spread': '50.80', 'groupId': 'OG001'}, {'value': '115.25', 'spread': '46.82', 'groupId': 'OG002'}, {'value': '147.2', 'spread': '27.23', 'groupId': 'OG003'}, {'value': '468.18', 'spread': '298.40', 'groupId': 'OG004'}, {'value': '1063.6', 'spread': '670.32', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During 2nd and 3rd visits', 'description': 'Participants were asked to click a button on a computer mouse and after a certaion number of responses, participants would receive a point. After 5 points, the participants received a portion of snack food.', 'unitOfMeasure': 'Number of button presses', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Energy Intake', 'timeFrame': 'visits 1, 2, and 3 plus on the phone throughout the study.', 'description': 'energy contained in eaten foods and beverages', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Body Weight', 'timeFrame': 'visit 1 and visit 3', 'description': 'body weight', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Height', 'timeFrame': 'visits 1 and 3', 'description': 'height', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Non-Obese/0 kcal', 'description': 'Non-obese participants that received no snack food to consume for two weeks.'}, {'id': 'FG001', 'title': 'Non-Obese/100 kcal', 'description': 'Non-obese participants that received a 100 kcal portion of food to consume daily for two weeks.'}, {'id': 'FG002', 'title': 'Non-obese/300 kcal', 'description': 'Non-obese participants that received a 300 kcal portion of food to consume daily for two weeks.'}, {'id': 'FG003', 'title': 'Obese/0 kcal', 'description': 'Obese participants that received no food to consume for two weeks.'}, {'id': 'FG004', 'title': 'Obese/100 kcal', 'description': 'Obese participants that received a 100 kcal portion of food to consume daily for two weeks.'}, {'id': 'FG005', 'title': 'Obese/300 kcal', 'description': 'Obese individuals who received a 300 kcal portion of food to consume for 2 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Women were recruited from flyers poster around campus. Interested participants called the lab and were screened by telephone.', 'preAssignmentDetails': 'Exclusionary criteria included smoking, current dieting, medications that could affect appetite, medical conditions that limited physical activity, allergies to or self-reported dislike of study foods.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '65', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Non-Obese/0 kcal', 'description': 'Non-obese participants that received no snack food to consume for two weeks.'}, {'id': 'BG001', 'title': 'Non-Obese/100 kcal', 'description': 'Non-obese participants that received a 100 kcal portion of food to consume daily for two weeks.'}, {'id': 'BG002', 'title': 'Non-obese/300 kcal', 'description': 'Non-obese participants that received a 300 kcal portion of food to consume daily for two weeks.'}, {'id': 'BG003', 'title': 'Obese/0 kcal', 'description': 'Obese participants that received no food to consume for two weeks.'}, {'id': 'BG004', 'title': 'Obese/100 kcal', 'description': 'Obese participants that received a 100 kcal portion of food to consume daily for two weeks.'}, {'id': 'BG005', 'title': 'Obese/300 kcal', 'description': 'Obese individuals who received a 300 kcal portion of food to consume for 2 weeks.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '65', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.57', 'spread': '7.37', 'groupId': 'BG000'}, {'value': '26.57', 'spread': '9.49', 'groupId': 'BG001'}, {'value': '29.13', 'spread': '7.37', 'groupId': 'BG002'}, {'value': '31.4', 'spread': '2.69', 'groupId': 'BG003'}, {'value': '37.82', 'spread': '2.85', 'groupId': 'BG004'}, {'value': '38.79', 'spread': '3.72', 'groupId': 'BG005'}, {'value': '32.13', 'spread': '10.7', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '65', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Minority', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '17.0', 'groupId': 'BG006'}]}]}, {'title': 'Non-Minority', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '48.0', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'description': 'Race (minority/non-minority)', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-07', 'studyFirstSubmitDate': '2009-02-03', 'resultsFirstSubmitDate': '2011-03-24', 'studyFirstSubmitQcDate': '2009-02-04', 'lastUpdatePostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-07', 'studyFirstPostDateStruct': {'date': '2009-02-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Responses Made by Clicking a Mouse Button for Food', 'timeFrame': 'During 2nd and 3rd visits', 'description': 'Participants were asked to click a button on a computer mouse and after a certaion number of responses, participants would receive a point. After 5 points, the participants received a portion of snack food.'}, {'measure': 'Energy Intake', 'timeFrame': 'visits 1, 2, and 3 plus on the phone throughout the study.', 'description': 'energy contained in eaten foods and beverages'}], 'secondaryOutcomes': [{'measure': 'Body Weight', 'timeFrame': 'visit 1 and visit 3', 'description': 'body weight'}, {'measure': 'Height', 'timeFrame': 'visits 1 and 3', 'description': 'height'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BMI', 'obesity', 'sensitization', 'food reinforcement', 'snack food', 'Portion size of daily snacks', 'Weight status'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '19458018', 'type': 'DERIVED', 'citation': 'Temple JL, Bulkley AM, Badawy RL, Krause N, McCann S, Epstein LH. Differential effects of daily snack food intake on the reinforcing value of food in obese and nonobese women. Am J Clin Nutr. 2009 Aug;90(2):304-13. doi: 10.3945/ajcn.2008.27283. Epub 2009 May 20.'}]}, 'descriptionModule': {'briefSummary': 'Food reinforcement, motivation to obtain food, is associated with energy intake and obesity. Finding ways to decrease the reinforcing value of unhealthy foods may help with adherence to diets and weight loss. Our previous study in non-obese adults showed that daily consumption of the same snack food (food typically consumed outside of meals) for 14 days significantly decreased its reinforcing value. The purpose of this study was to replicate and extend these findings to obese individuals as well as to examine effects of different portion sizes of snack foods on food reinforcement. Thirty-one obese (body mass index \\> 30 kg/m2) and 27 non-obese (BMI \\< 30 kg/m2) women had food reinforcement and liking tested at baseline and after two weeks of daily consumption of either 0 kcal, 100 kcals, or 300 kcals daily of the same snack food.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women ages 18 - 50 years who were obese (body mass index \\>/= 30) or non-obese (BMI \\< 30)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women\n* non-smoker\n* not on a diet\n* no restrained eating\n* had to like potential snack foods\n* willing to visit the laboratory 3 times\n* willing to eat snacks provided\n* no medications or medical conditions that affect appetite\n* no food allergies\n\nExclusion Criteria:\n\n* see above'}, 'identificationModule': {'nctId': 'NCT00837694', 'briefTitle': 'Snack Food Reinforcement in Obese and Non-obese Women', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Differential Effects of Daily Snack Food Intake on Reinforcing Value of Food in Obese and Non-obese Women.', 'orgStudyIdInfo': {'id': 'Temple1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Non-obese/0 kcal'}, {'label': '2', 'description': 'Non-obese/100 kcal'}, {'label': '3', 'description': 'Non-obese/300 kcal'}, {'label': '4', 'description': 'Obese/0 kcal'}, {'label': '5', 'description': 'Obese/100 kcal'}, {'label': '6', 'description': 'Obese/300 kcal'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14214', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University at Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Jennifer L Temple, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University at Buffalo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jennifer Temple', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}