Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-01-04 @ 7:35 AM
Study NCT ID:
NCT03597061
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2018-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Healthy Start to Feeding Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'odarcc@ucmail.uc.edu', 'phone': '513-556-5589', 'title': 'Cathleen Stough, Ph.D.', 'organization': 'University of Cincinnati'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From baseline to post-treatment (approximately 6 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Start to Feeding Intervention', 'description': "Participants and their parents will participate in a 3 session intervention targeting healthy introduction of complementary foods. Intervention sessions will occur when the infant is 4, 6, and 9 months of age.\n\nHealthy Start to Feeding: The intervention provides parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content is manualized and administered by interventionists with expertise in child development and behavioral strategies for managing child eating behaviors under the supervision of a licensed clinical child psychologist and pediatric occupational therapist. Sessions are conducted individually with participants and primary caregivers and include educational content, handouts and instructions, modeling of skills by the interventionist, caregiver practicing of skills in session, establishment of behavioral goals, and problem solving barriers to implementation of treatment content. Content will include topics such as allowing infants' own hunger and satiety cues to guide the feeding experience, introducing healthy foods, parental attunement to infant satiety cues, and promoting infants' own self-feeding.", 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Participants and their parents will complete pre- and post-treatment period study visits to assess study outcomes. They will receive no intervention.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Weight-for-Length Percentile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Start to Feeding Intervention', 'description': "Participants and their parents participated in a 3-session intervention targeting healthy introduction of complementary foods. Intervention sessions occurred when the infant was 4, 6, and 9 months of age.\n\nHealthy Start to Feeding: The intervention provided parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content was manualized and administered by interventionists with expertise in child development and behavioral strategies for managing child eating behaviors under the supervision of a licensed clinical child psychologist and pediatric occupational therapist. Sessions were conducted individually with participants and primary caregivers and included educational content, handouts and instructions, modeling of skills by the interventionist, caregiver practicing of skills in session, establishment of behavioral goals, and problem solving barriers to implementation of treatment content. Content included topics such as allowing infants' own hunger and satiety cues to guide the feeding experience, introducing healthy foods, parental attunement to infant satiety cues, and promoting infants' own self-feeding."}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants and their parents completed pre- and post-treatment study visits to assess study outcomes. They received no intervention.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '44.94', 'spread': '30.25', 'groupId': 'OG000'}, {'value': '46.70', 'spread': '26.97', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '58.69', 'spread': '31.78', 'groupId': 'OG000'}, {'value': '48.54', 'spread': '30.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weight and length were measured at both pre-treatment (when infant was 3 months of age) and post-treatment (when infant was 9 months of age).', 'description': 'Infant anthropometrics of weight and length were measured and used to calculate weight-for-length percentile standardized for age and gender.', 'unitOfMeasure': 'Percentile', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Appetite Regulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Start to Feeding Intervention', 'description': "Participants and their parents participated in a 3-session intervention targeting healthy introduction of complementary foods. Intervention sessions occurred when the infant was 4, 6, and 9 months of age.\n\nHealthy Start to Feeding: The intervention provided parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content was manualized and administered by interventionists with expertise in child development and behavioral strategies for managing child eating behaviors under the supervision of a licensed clinical child psychologist and pediatric occupational therapist. Sessions were conducted individually with participants and primary caregivers and included educational content, handouts and instructions, modeling of skills by the interventionist, caregiver practicing of skills in session, establishment of behavioral goals, and problem solving barriers to implementation of treatment content. Content included topics such as allowing infants' own hunger and satiety cues to guide the feeding experience, introducing healthy foods, parental attunement to infant satiety cues, and promoting infants' own self-feeding."}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants and their parents completed pre- and post-treatment study visits to assess study outcomes. They received no intervention.'}], 'classes': [{'title': 'Pre-treatment: Food Responsiveness', 'categories': [{'measurements': [{'value': '2.96', 'spread': '.33', 'groupId': 'OG000'}, {'value': '3.01', 'spread': '.24', 'groupId': 'OG001'}]}]}, {'title': 'Pre-treatment: Enjoyment of Food', 'categories': [{'measurements': [{'value': '3.61', 'spread': '.27', 'groupId': 'OG000'}, {'value': '3.72', 'spread': '.35', 'groupId': 'OG001'}]}]}, {'title': 'Pre-treatment: Satiety Responsiveness', 'categories': [{'measurements': [{'value': '1.92', 'spread': '.49', 'groupId': 'OG000'}, {'value': '1.85', 'spread': '.30', 'groupId': 'OG001'}]}]}, {'title': 'Pre-treatment: Slowness in Eating', 'categories': [{'measurements': [{'value': '2.59', 'spread': '.48', 'groupId': 'OG000'}, {'value': '2.73', 'spread': '.48', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment: Food Responsiveness', 'categories': [{'measurements': [{'value': '2.82', 'spread': '.46', 'groupId': 'OG000'}, {'value': '2.97', 'spread': '.29', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment: Enjoyment of Food', 'categories': [{'measurements': [{'value': '3.70', 'spread': '.26', 'groupId': 'OG000'}, {'value': '3.58', 'spread': '.24', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment: Satiety Responsiveness', 'categories': [{'measurements': [{'value': '1.54', 'spread': '.45', 'groupId': 'OG000'}, {'value': '1.96', 'spread': '.36', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment: Slowness in Eating', 'categories': [{'measurements': [{'value': '2.41', 'spread': '.41', 'groupId': 'OG000'}, {'value': '2.58', 'spread': '.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The BEBQ was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).', 'description': 'Infant satiety and food responsiveness was measured using the parent-report Baby Eating Behavior Questionnaire (BEBQ). The BEBQ provides subscale scores for "Food Responsiveness", "Enjoyment of Food", "Satiety Responsiveness", and "Slowness in Eating" with each subscale score ranging from 1 to 5, with 5 representing higher values on that construct. Each subscale score is computed as the average of all individual items on that subscales.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Fruit and Vegetable Variety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Start to Feeding Intervention', 'description': "Participants and their parents participated in a 3-session intervention targeting healthy introduction of complementary foods. Intervention sessions occurred when the infant was 4, 6, and 9 months of age.\n\nHealthy Start to Feeding: The intervention provided parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content was manualized and administered by interventionists with expertise in child development and behavioral strategies for managing child eating behaviors under the supervision of a licensed clinical child psychologist and pediatric occupational therapist. Sessions were conducted individually with participants and primary caregivers and included educational content, handouts and instructions, modeling of skills by the interventionist, caregiver practicing of skills in session, establishment of behavioral goals, and problem solving barriers to implementation of treatment content. Content included topics such as allowing infants' own hunger and satiety cues to guide the feeding experience, introducing healthy foods, parental attunement to infant satiety cues, and promoting infants' own self-feeding."}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants and their parents completed pre- and post-treatment study visits to assess study outcomes. They received no intervention.'}], 'classes': [{'title': 'Post-treatment: Fruit Servings Per Day', 'categories': [{'measurements': [{'value': '1.86', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '2.19', 'spread': '1.11', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment: Veggie Servings Per Day', 'categories': [{'measurements': [{'value': '4.92', 'spread': '3.63', 'groupId': 'OG000'}, {'value': '5.10', 'spread': '3.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The Block Food Frequency Questionnaire was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).', 'description': "Fruit and vegetable variety was assessed using the parent-report Block Food Frequency Questionnaire. Scores were calculated for servings of vegetables per day and servings of fruits per day. The minimum value is 0. There is no upper-bound for the maximum value, as this is dependent on the individual participant's food consumption. Higher numbers indicate greater consumption. Only post-treatment results are presented since infants had not been introduced to solid foods at the time of baseline.", 'unitOfMeasure': 'Servings per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Family Satisfaction - Defined as Appropriateness of the Intervention Content and Session Timing, Clarity of Information, Knowledge of the Recommendations, Helpfulness, and Whether They Would Recommend the Intervention to Others.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Start to Feeding Intervention', 'description': "Participants and their parents participated in a 3-session intervention targeting healthy introduction of complementary foods. Intervention sessions occurred when the infant was 4, 6, and 9 months of age.\n\nHealthy Start to Feeding: The intervention provided parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content was manualized and administered by interventionists with expertise in child development and behavioral strategies for managing child eating behaviors under the supervision of a licensed clinical child psychologist and pediatric occupational therapist. Sessions were conducted individually with participants and primary caregivers and included educational content, handouts and instructions, modeling of skills by the interventionist, caregiver practicing of skills in session, establishment of behavioral goals, and problem solving barriers to implementation of treatment content. Content included topics such as allowing infants' own hunger and satiety cues to guide the feeding experience, introducing healthy foods, parental attunement to infant satiety cues, and promoting infants' own self-feeding."}], 'classes': [{'title': 'Appropriateness', 'categories': [{'measurements': [{'value': '4.60', 'spread': '1.06', 'groupId': 'OG000'}]}]}, {'title': 'Timing', 'categories': [{'measurements': [{'value': '4.47', 'spread': '1.13', 'groupId': 'OG000'}]}]}, {'title': 'Clarity', 'categories': [{'measurements': [{'value': '4.67', 'spread': '1.05', 'groupId': 'OG000'}]}]}, {'title': 'Implementation', 'categories': [{'measurements': [{'value': '4.67', 'spread': '1.05', 'groupId': 'OG000'}]}]}, {'title': 'Helpful', 'categories': [{'measurements': [{'value': '4.53', 'spread': '.83', 'groupId': 'OG000'}]}]}, {'title': 'Satisfication', 'categories': [{'measurements': [{'value': '4.47', 'spread': '1.25', 'groupId': 'OG000'}]}]}, {'title': 'Would Recommend', 'categories': [{'measurements': [{'value': '4.47', 'spread': '1.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The measure of family satisfaction will be completed at post-treatment (when the child is 9 months of age).', 'description': 'Caregivers in the treatment condition completed a survey measuring whether parents found the intervention appropriate for their infant, whether sessions occurred at the right time, whether information was presented clearly, whether they knew how to implement the recommendations, whether the intervention was helpful, whether they were satisfied with the intervention, and whether they would recommend the intervention to a friend/family member/coworker. Each satisfaction attribute will be assessed on a 1-5 Likert scale with higher scores indicating higher agreement. Information from each individual item will be used, and no total or subscale scores will be computed. Parents also provided qualitative information on what additional information should be included in the intervention, what information was not helpful, what should be changed about the intervention, and what should stay the same about the intervention.', 'unitOfMeasure': 'Item scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment Attendance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Start to Feeding Intervention', 'description': "Participants and their parents participated in a 3-session intervention targeting healthy introduction of complementary foods. Intervention sessions occurred when the infant was 4, 6, and 9 months of age.\n\nHealthy Start to Feeding: The intervention provided parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content was manualized and administered by interventionists with expertise in child development and behavioral strategies for managing child eating behaviors under the supervision of a licensed clinical child psychologist and pediatric occupational therapist. Sessions were conducted individually with participants and primary caregivers and included educational content, handouts and instructions, modeling of skills by the interventionist, caregiver practicing of skills in session, establishment of behavioral goals, and problem solving barriers to implementation of treatment content. Content included topics such as allowing infants' own hunger and satiety cues to guide the feeding experience, introducing healthy foods, parental attunement to infant satiety cues, and promoting infants' own self-feeding."}], 'classes': [{'title': 'Attended Session 1', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Attended Session 2', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Attended Session 3', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Attendance of sessions at study month 2 (session 1), study month 4 (session 2), and study month 7 (session 3) was recorded. The number of sessions that each participant attended was calculated.', 'description': 'Treatment attendance was tracked for each family.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Participants and their parents will complete pre- and post-treatment period study visits to assess study outcomes. They will receive no intervention.'}, {'id': 'FG001', 'title': 'Healthy Start to Feeding Intervention', 'description': "Participants and their parents will participate in a 3 session intervention targeting healthy introduction of complementary foods. Intervention sessions will occur when the infant is 4, 6, and 9 months of age.\n\nHealthy Start to Feeding: The intervention provides parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content is manualized and administered by interventionists with expertise in child development and behavioral strategies for managing child eating behaviors under the supervision of a licensed clinical child psychologist and pediatric occupational therapist. Sessions are conducted individually with participants and primary caregivers and include educational content, handouts and instructions, modeling of skills by the interventionist, caregiver practicing of skills in session, establishment of behavioral goals, and problem solving barriers to implementation of treatment content. Content will include topics such as allowing infants' own hunger and satiety cues to guide the feeding experience, introducing healthy foods, parental attunement to infant satiety cues, and promoting infants' own self-feeding."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Start to Feeding Intervention', 'description': "Participants and their parents participated in a 3-session intervention targeting healthy introduction of complementary foods. Intervention sessions occurred when the infant was 4, 6, and 9 months of age.\n\nHealthy Start to Feeding: The intervention provided parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content was manualized and administered by interventionists with expertise in child development and behavioral strategies for managing child eating behaviors under the supervision of a licensed clinical child psychologist and pediatric occupational therapist. Sessions were conducted individually with participants and primary caregivers and included educational content, handouts and instructions, modeling of skills by the interventionist, caregiver practicing of skills in session, establishment of behavioral goals, and problem solving barriers to implementation of treatment content. Content included topics such as allowing infants' own hunger and satiety cues to guide the feeding experience, introducing healthy foods, parental attunement to infant satiety cues, and promoting infants' own self-feeding."}, {'id': 'BG001', 'title': 'Control', 'description': 'Participants and their parents completed pre- and post-treatment study visits to assess study outcomes. They received no intervention.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-09', 'size': 244103, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_004.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-24T17:25', 'hasProtocol': True}, {'date': '2018-07-09', 'size': 158777, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_005.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-24T17:24', 'hasProtocol': False}, {'date': '2018-07-09', 'size': 560495, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_006.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-06-24T17:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Infants will be assigned to either the treatment or control condition.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2018-06-27', 'resultsFirstSubmitDate': '2021-05-20', 'studyFirstSubmitQcDate': '2018-07-13', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-25', 'studyFirstPostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight-for-Length Percentile', 'timeFrame': 'Weight and length were measured at both pre-treatment (when infant was 3 months of age) and post-treatment (when infant was 9 months of age).', 'description': 'Infant anthropometrics of weight and length were measured and used to calculate weight-for-length percentile standardized for age and gender.'}, {'measure': 'Appetite Regulation', 'timeFrame': 'The BEBQ was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).', 'description': 'Infant satiety and food responsiveness was measured using the parent-report Baby Eating Behavior Questionnaire (BEBQ). The BEBQ provides subscale scores for "Food Responsiveness", "Enjoyment of Food", "Satiety Responsiveness", and "Slowness in Eating" with each subscale score ranging from 1 to 5, with 5 representing higher values on that construct. Each subscale score is computed as the average of all individual items on that subscales.'}, {'measure': 'Fruit and Vegetable Variety', 'timeFrame': 'The Block Food Frequency Questionnaire was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).', 'description': "Fruit and vegetable variety was assessed using the parent-report Block Food Frequency Questionnaire. Scores were calculated for servings of vegetables per day and servings of fruits per day. The minimum value is 0. There is no upper-bound for the maximum value, as this is dependent on the individual participant's food consumption. Higher numbers indicate greater consumption. Only post-treatment results are presented since infants had not been introduced to solid foods at the time of baseline."}], 'secondaryOutcomes': [{'measure': 'Family Satisfaction - Defined as Appropriateness of the Intervention Content and Session Timing, Clarity of Information, Knowledge of the Recommendations, Helpfulness, and Whether They Would Recommend the Intervention to Others.', 'timeFrame': 'The measure of family satisfaction will be completed at post-treatment (when the child is 9 months of age).', 'description': 'Caregivers in the treatment condition completed a survey measuring whether parents found the intervention appropriate for their infant, whether sessions occurred at the right time, whether information was presented clearly, whether they knew how to implement the recommendations, whether the intervention was helpful, whether they were satisfied with the intervention, and whether they would recommend the intervention to a friend/family member/coworker. Each satisfaction attribute will be assessed on a 1-5 Likert scale with higher scores indicating higher agreement. Information from each individual item will be used, and no total or subscale scores will be computed. Parents also provided qualitative information on what additional information should be included in the intervention, what information was not helpful, what should be changed about the intervention, and what should stay the same about the intervention.'}, {'measure': 'Treatment Attendance', 'timeFrame': 'Attendance of sessions at study month 2 (session 1), study month 4 (session 2), and study month 7 (session 3) was recorded. The number of sessions that each participant attended was calculated.', 'description': 'Treatment attendance was tracked for each family.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity prevention', 'infant', 'complementary feeding', 'diet variety', 'weight-for-length', 'food responsiveness', 'satiety responsiveness'], 'conditions': ['Weight, Body', 'Diet Habit']}, 'referencesModule': {'references': [{'pmid': '32710657', 'type': 'DERIVED', 'citation': 'Ojha S, Elfzzani Z, Kwok TC, Dorling J. Education of family members to support weaning to solids and nutrition in later infancy in term-born infants. Cochrane Database Syst Rev. 2020 Jul 25;7(7):CD012241. doi: 10.1002/14651858.CD012241.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The current study will test the impact of a 3-session obesity prevention program targeting healthy introduction of solid foods in infancy on growth trajectories, appetite regulation, and diet. The investigators will also test the feasibility and family satisfaction with the treatment. Healthy infants with normal and elevated weight-for-length will be enrolled in the study at 3 months of age and complete an initial study visit to assess baseline anthropometrics,demographics, parental feeding practices and beliefs, and infant appetite. Infants will than be randomly assigned to either the treatment condition (n = 20) or control condition (n = 20). Infants in the control condition will receive no intervention or further contact with the study team besides for completion of a final study assessment visit when the child is 9 months old. Infants in the treatment condition will receive a 3 session intervention targeting healthy introduction of solid foods, with study visits occurring when the child is 4 months, 6 months, and 9 months old. All families will complete a final study visit to complete post-treatment period measurements, which will include infant anthropometrics and parent-report of infant appetite, infant diet, and parental feeding practices and beliefs. Outcomes include: weight-for-length percentile, infant satiety responsiveness, infant food responsiveness, and infant fruit and vegetable consumption. Family satisfaction and treatment attendance will also be assessed.', 'detailedDescription': "The purpose of this research study is to pilot test a prevention program to promote healthy introduction of solid foods and healthy weight gain among infants. Introduction of complementary foods (i.e., foods besides formula or breast milk) represents a major dietary milestone for infants. The current study will test the feasibility of a 3-session intervention encouraging healthy introduction of complementary foods and use of a responsive feeding approach. Feasibility of the intervention and the impact of the Healthy Start to Feeding (HSF) intervention on obesity risk factors and growth will be explored. This will be achieved through exploration of the following aims and hypotheses:\n\nAim 1: Determine feasibility of the intervention and family satisfaction with the treatment.\n\nH1: Families assigned to the intervention condition will attend equal to or greater than 67% of treatment sessions.\n\nH2: Families receiving the intervention will rate the program as helpful and consistent with the families' needs and priorities.\n\nAim 2: Test the impact of the HSF intervention on growth trajectories, appetite regulation, and diet at post-treatment.\n\nH1: Infants receiving the intervention will experience lower incidence of high weight-for-length (\\> 85th percentile) compared to infants in the control condition.\n\nH2: Infants in the treatment condition will show greater satiety responsiveness and lower food responsiveness as assessed through a well-validated parent-report measure (Baby Eating Behavior Questionnaire; Llewellyn, van Jaarsveld, Johnson, Carnell, \\& Wardle, 2010).\n\nH3: Infants in the treatment condition will consume a greater variety of fruits and vegetables than infants in the control condition as assessed through a food frequency questionnaire completed by parents."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Months', 'minimumAge': '3 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Infant aged 2-3 months at study recruitment\n* Infant not previously introduced to complementary foods (i.e., any food besides formula or breastmilk)\n* Infant born at \\> 38 weeks gestation\n* Infant weight-for-length \\> 10th percentile\n* Parent is fluent English speaker\n\nExclusion Criteria:\n\n* Known infant developmental delay\n* Impaired infant fine or gross motor skills\n* Condition currently impacting the infant's feeding and eating"}, 'identificationModule': {'nctId': 'NCT03597061', 'briefTitle': 'Healthy Start to Feeding Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'Healthy Start to Feeding Pilot Trial', 'orgStudyIdInfo': {'id': '2017-7248'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Start to Feeding Intervention', 'description': 'Participants and their parents will participate in a 3 session intervention targeting healthy introduction of complementary foods. Intervention sessions will occur when the infant is 4, 6, and 9 months of age.', 'interventionNames': ['Behavioral: Healthy Start to Feeding']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants and their parents will complete pre- and post-treatment period study visits to assess study outcomes. They will receive no intervention.'}], 'interventions': [{'name': 'Healthy Start to Feeding', 'type': 'BEHAVIORAL', 'description': "The intervention provides parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content is manualized and administered by interventionists with expertise in child development and behavioral strategies for managing child eating behaviors under the supervision of a licensed clinical child psychologist and pediatric occupational therapist. Sessions are conducted individually with participants and primary caregivers and include educational content, handouts and instructions, modeling of skills by the interventionist, caregiver practicing of skills in session, establishment of behavioral goals, and problem solving barriers to implementation of treatment content. Content will include topics such as allowing infants' own hunger and satiety cues to guide the feeding experience, introducing healthy foods, parental attunement to infant satiety cues, and promoting infants' own self-feeding.", 'armGroupLabels': ['Healthy Start to Feeding Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Cathleen Stough, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Data collected at baseline will be made available at the time of acceptance of the first publication presenting this data, which will be submitted for publication no later than 1 year following the completion of baseline data collection. All other data collected throughout the project will be made available at the time of acceptance of the primary treatment outcomes paper, which will be submitted for publication no later than 1 year following the completion of the last post-treatment visit.', 'ipdSharing': 'YES', 'description': "Data collected will be shared through 1) dissemination of aggregate data through scientific publication, summary on the research laboratory's website, and presentation at regional, national, and international conferences and 2) availability of data to requesting researchers and investigators. Researchers interested in receiving the dataset should request the dataset from the principal investigator.\n\nIn addition to these two avenues for data sharing, if provided the opportunity at the time of publication, the dataset will be uploaded to any data repository offered through the scientific journal in which findings are published.", 'accessCriteria': 'Requesting researchers and investigators will be asked to use the data only for IRB-approved or exempted research purposes and to present only aggregate descriptions of data that do not identify any one participant.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Cathy Stough', 'investigatorAffiliation': 'University of Cincinnati'}}}}