Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2026-02-22 @ 1:47 AM
Study NCT ID:
NCT02701868
Status:
COMPLETED
Last Update Posted:
2021-01-14
First Post:
2016-02-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Unintentional Overfeeding of Formula Fed Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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': 'Abby.Altazan@pbrc.edu', 'phone': '2257632801', 'title': 'Abby Altazan', 'organization': 'Pennington Biomedical Research Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "This study involved two phases: Phase 1 was participatory research where participants were involved in focus groups and Phase 2 was a double-blind randomized controlled trial where participants were randomly assigned to prepare infant formula bottles using the standard manufacturer's instructions or the instructions that were modified as a result of Phase 1 focus groups. Due to the design, primary outcomes were different for Phase 1 and Phase 2. Both primary outcomes are included in the results."}}, 'adverseEventsModule': {'timeFrame': '1 day', 'description': 'Adverse event data were not collected systematically as part of study data, but reported by study participants as applicable.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1', 'description': 'Up to 40 individuals will be recruited to participate in focus groups at Pennington Biomedical Research Center. Approximately six focus groups (each with 5-10 participants) will be conducted at the Pennington Biomedical Research Center Demonstration Kitchen over the course of approximately 3 months.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Phase 2 Standard Instructions', 'description': 'Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited for Phase 2. Up to 75 individuals will be randomized to prepare infant formula using standard instructions.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Phase 2 Modified Instructions', 'description': 'Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited for Phase 2. Up to 75 individuals will be randomized to prepare infant formula using modified instructions.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Focus Group Recommendations to Improve Infant Formula Preparation Instructions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1', 'description': 'Up to 40 individuals will be recruited to participate in focus groups at Pennington Biomedical Research Center. Approximately six focus groups (each with 5-10 participants) will be conducted at the Pennington Biomedical Demonstration Kitchen over the course of approximately 3 months.'}, {'id': 'OG001', 'title': 'Phase 2', 'description': 'Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited to test the efficacy of the revised instructions on infant overfeeding in comparison with the instructions currently provided on the packaging.'}], 'classes': [{'title': 'Pictures were helpful', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Clarify Safety Information', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Define and emphasize "level" and "unpacked" scoop', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Move mixing guide to the top', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Focus groups were used to evaluate and provide recommendations to improve the reading and comprehension of powdered infant formula package preparation instructions. Five focus groups provided primary recommendations. The percentage of focus group participants reporting specific recommendations are summarized.', 'unitOfMeasure': 'percentage of focus group participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The focus groups were only completed for Phase 1 participants. This outcome measure does not apply to Phase 2 participants who did not participate in focus groups and provide infant formula preparation instructions.'}, {'type': 'PRIMARY', 'title': 'Percent Error of Dispensed Formula Weight as Compared to Expected Formula Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1', 'description': 'Up to 40 individuals will be recruited to participate in focus groups at Pennington Biomedical Research Center. Approximately six focus groups (each with 5-10 participants) will be conducted at the Pennington Biomedical Demonstration Kitchen over the course of approximately 3 months.'}, {'id': 'OG001', 'title': 'Phase 2 Standard Instructions', 'description': 'Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited for Phase 2. Up to 75 individuals will be randomized to prepare infant formula using standard instructions.'}, {'id': 'OG002', 'title': 'Phase 2 Modified Instructions', 'description': 'Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited for Phase 2. Up to 75 individuals will be randomized to prepare infant formula using modified instructions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.66', 'spread': '0.74', 'groupId': 'OG001'}, {'value': '-0.67', 'spread': '0.76', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': "Percent Error of the formula weight prepared by Phase 2 study participants as compared to the expected formula weight from the manufacturer's label. Phase 2 participants were either randomly assigned the standard instructions or the instructions that were modified as a result of the Phase 1 focus groups.\n\nPercent error was calculated as the measured formula weight prepared by Phase 2 study participants subtracted from the expected formula weight found on the manufacturer's label with that result being divided by the expected formula weight found on the manufacturer's label. The final result is multiplied by 100 to provide the percent error. Percent error is presented as opposed to formula weight because each participant prepared two 2, 4, 6, and 8 oz bottles. Percent error analysis includes all bottles prepared regardless of size.", 'unitOfMeasure': 'percentage of error', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure does not apply to Phase 1 participants because Phase 1 participants did not participate in the double blind, randomized controlled portion of the trial. Phase 1 participants did not prepare infant formula bottles according to either the standard or modified instructions.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1', 'description': 'Up to 40 individuals will be recruited to participate in focus groups at Pennington Biomedical Research Center. Approximately six focus groups (each with 5-10 participants) will be conducted at the Pennington Biomedical Research Center Demonstration Kitchen over the course of approximately 3 months.'}, {'id': 'FG001', 'title': 'Phase 2 Standard Instructions', 'description': 'Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited for Phase 2. Up to 75 individuals will be randomized to prepare infant formula using standard instructions.'}, {'id': 'FG002', 'title': 'Phase 2 Modified Instructions', 'description': 'Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited for Phase 2. Up to 75 individuals will be randomized to prepare infant formula using modified instructions.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1', 'description': 'Up to 40 individuals will be recruited to participate in focus groups at Pennington Biomedical Research Center. Approximately six focus groups (each with 5-10 participants) will be conducted at the Pennington Biomedical Demonstration Kitchen over the course of approximately 3 months.'}, {'id': 'BG001', 'title': 'Phase 2 Standard Instructions', 'description': 'Up to 75 individuals who did not participate in Whoa Baby Phase 1 were recruited to prepare bottles using the standard infant formula preparation instructions.'}, {'id': 'BG002', 'title': 'Phase 2 Modified Instructions', 'description': "Up to 75 individuals who did not participate in Whoa Baby Phase 1 were recruited to prepare bottles using the modified infant formula preparation instructions. The modified instructions were developed as a result of the focus groups' conditions in Phase 1."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.5', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '36.0', 'spread': '15.8', 'groupId': 'BG001'}, {'value': '40.6', 'spread': '17.6', 'groupId': 'BG002'}, {'value': '37.8', 'spread': '16.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.8', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '29.6', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '29.5', 'spread': '7.9', 'groupId': 'BG002'}, {'value': '29.2', 'spread': '7.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Education, Categorical', 'classes': [{'categories': [{'title': 'High School Diploma/GED or Less', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': '1-3 Years College', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}, {'title': 'College Degree', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}, {'title': 'Post-Graduate Degree', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Income, Categorical', 'classes': [{'categories': [{'title': '<$30,000/year', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}, {'title': '$30,000-$99,999/year', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}, {'title': '>$80,000/year', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}, {'title': 'No answer', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-06-28', 'size': 1089509, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-23T14:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-21', 'studyFirstSubmitDate': '2016-02-22', 'resultsFirstSubmitDate': '2020-10-05', 'studyFirstSubmitQcDate': '2016-03-02', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-21', 'studyFirstPostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Focus Group Recommendations to Improve Infant Formula Preparation Instructions', 'timeFrame': 'Day 1', 'description': 'Focus groups were used to evaluate and provide recommendations to improve the reading and comprehension of powdered infant formula package preparation instructions. Five focus groups provided primary recommendations. The percentage of focus group participants reporting specific recommendations are summarized.'}, {'measure': 'Percent Error of Dispensed Formula Weight as Compared to Expected Formula Weight', 'timeFrame': 'Day 1', 'description': "Percent Error of the formula weight prepared by Phase 2 study participants as compared to the expected formula weight from the manufacturer's label. Phase 2 participants were either randomly assigned the standard instructions or the instructions that were modified as a result of the Phase 1 focus groups.\n\nPercent error was calculated as the measured formula weight prepared by Phase 2 study participants subtracted from the expected formula weight found on the manufacturer's label with that result being divided by the expected formula weight found on the manufacturer's label. The final result is multiplied by 100 to provide the percent error. Percent error is presented as opposed to formula weight because each participant prepared two 2, 4, 6, and 8 oz bottles. Percent error analysis includes all bottles prepared regardless of size."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infant Formula'], 'conditions': ['Childhood Obesity', 'Infant Development']}, 'descriptionModule': {'briefSummary': 'Although breast milk is recommended exclusively until 6 months of age, two-thirds of infants in the U.S. are fed infant formula. Despite an almost identical energy density between infant formula and breast milk, formula fed infants experience greater weight gain in the first year of life. The investigators propose that unintentional overfeeding, of nearly one additional day of calories per week, due to the "over-scooping" of powdered formula contributes significantly to this phenomenon and potentially to the early development of childhood obesity, a significant public health problem.', 'detailedDescription': 'In the proposed study the investigators will assess the literacy and understanding of individuals to follow commercially available infant formula instructions. The investigators will collaborate with the LA CaTS Health Literacy Core to improve the reading and comprehension of the manufacturer package instruction, and will solicit the input of caregivers and key stakeholders to inform the development of educational intervention around infant feeding. Following modification of infant formula preparation instructions, the investigators will conduct a randomized controlled trial that will test the efficacy of the modified instructions on infant overfeeding in comparison with the manufacturer package instructions. One hundred and fifty participants will be asked to complete one study visit during which they will be asked to measure various serving sizes of infant formula following either the manufacturer package instructions or the modified instructions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Up to 40 individuals will be recruited to participate in focus groups at Pennington Biomedical Research Center. Phase 1 will utilize qualitative data gathered from focus groups to direct the modification of infant formula manufacturer preparation instructions to enhance user understanding and accuracy. The modified instructions will be used in Phase 2.\n\nUp to 150 individuals will be enrolled in Phase 2 to test the efficacy of the revised instructions on infant overfeeding in comparison with the instructions currently provided on the packaging.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years of age\n* Willing to participate in 1 assessment visit at Pennington Biomedical Research Center\n* English speaking\n\nExclusion Criteria:\n\n* \\<18 years of age\n* Not willing to participate in 1 assessment visit at Pennington Biomedical Research Center\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT02701868', 'acronym': 'Whoa Baby', 'briefTitle': 'Unintentional Overfeeding of Formula Fed Infants', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'Unintentional Overfeeding of Formula Fed Infants', 'orgStudyIdInfo': {'id': 'PBRC2016-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Phase 1', 'description': 'Up to 40 individuals will be recruited to participate in focus groups at Pennington Biomedical Research Center. Approximately six focus groups (each with 5-10 participants) will be conducted at the Pennington Biomedical Demonstration Kitchen over the course of approximately 3 months.'}, {'label': 'Phase 2', 'description': 'Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited to test the efficacy of the revised instructions on infant overfeeding in comparison with the instructions currently provided on the packaging.'}]}, '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': 'Anne Gilmore, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoctoral Fellow', 'investigatorFullName': 'Anne Gilmore', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}