Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-02-24 @ 5:06 AM
Study NCT ID:
NCT02202733
Status:
COMPLETED
Last Update Posted:
2015-07-14
First Post:
2014-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skill-based Cooking Intervention to Reduce Eating Out
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003296', 'term': 'Cooking'}], 'ancestors': [{'id': 'D005511', 'term': 'Food Handling'}, {'id': 'D019649', 'term': 'Food Industry'}, {'id': 'D007221', 'term': 'Industry'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-13', 'studyFirstSubmitDate': '2014-07-25', 'studyFirstSubmitQcDate': '2014-07-28', 'lastUpdatePostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dietary Intake (Phase II only)', 'timeFrame': '0 and 10 weeks', 'description': 'Caregivers will be asked to complete a 7-day dietary record of what they and their child eat at the evening meal. For each evening meal, the caretaker will be asked to describe the meal type (fast food, restaurant, pre-prepared frozen meal, or home prepared); the specific foods and drinks consumed, and the amount consumed by the child. Data from dietary records will be input into Nutrition Data System for Research (NDSR) software and analyzed for energy intake, percent energy from fat, and food groups (fruits, vegetables, grains, proteins, dairy) from the evening meal. Foods prepared away from home will be classified based on caretaker indication of fast food, restaurant, pre-prepared frozen meal, or home prepared on the dietary record.'}], 'secondaryOutcomes': [{'measure': 'Caretaker Attitudes and Confidence', 'timeFrame': '0 and 10 weeks', 'description': 'Caretakers will report ease of providing foods prepared away from home (i.e., pre-prepared frozen meals, restaurant food, fast food, take-out) for an evening meal, ease of providing a home prepared evening meal, and their confidence with meal preparation using a 100-mm visual analog scale (VAS). Further caretakers will rate their ability, enjoyment of cooking and desire to cook on a 100-mm VAS.'}, {'measure': 'Food Costs', 'timeFrame': '0 and 10 weeks', 'description': 'Caretakers will be provided with four visual images with each image showing one adult evening meal and two child evening meals. Caretaker will record the total cost of the meals shown in each image.'}, {'measure': 'Portions', 'timeFrame': '0 and 10 weeks', 'description': 'Caretakers will be provided with visual images of foods in different portion amounts and asked to identify which image best represents the amount their child would be served for dinner. Caretakers will also identify the images that best represent the amount they would serve themselves for dinner.'}, {'measure': 'Dinner Choices', 'timeFrame': '0 and 10 weeks', 'description': 'Caretakers will complete a 10-question, open-ended questionnaire that solicits information related to choices of foods prepared away from home and foods prepared at home.'}, {'measure': 'Anthropometrics', 'timeFrame': '0 adn 10 weeks', 'description': 'Height and weight will be measured using standard procedures.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cooking skills', 'eating out', 'foods prepared away from home'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The primary goal of the study is to use an iterative process to develop and refine a skill-based cooking intervention to decrease the consumption of energy from foods prepared away from home for evening meals, decrease energy intake, and promote a healthy weight in parents and children aged 3-10 years.', 'detailedDescription': 'Phase I. Conduct 2-4 focus groups with 6-10 caretaker, who report eating foods prepared away from home ≥3 times per week, per group to gain insight into current eating behaviors of foods prepared away from home, current perceptions about a home prepared evening meal, and barriers to preparing evening meals at home. Information gathered during Phase I will be used to inform intervention development in Phase II.\n\nPhase II. Develop, refine, and manualize a skill-based cooking intervention for overweight/obese caretakers of a child aged 3-10 years. The aim of Phase II is to test the feasibility of a skill-based cooking intervention to reduce the consumption of foods prepared away from home for the evening meal (e.g., pre-prepared frozen foods, restaurant foods, fast food, take-out), energy intake from evening meals, and promote a healthy weight in parents and children. Information collected during Phase I will inform the development of the skill-based cooking intervention. Once developed, the intervention will be refined with 6 primary caretakers of a child, who meet criteria for being overweight/obese during a testing phase. Conducting the intervention with at least six families will provide the opportunity for further refinement of intervention procedures. The results will be important to demonstrate feasibility for a future pilot randomized controlled trial that will test the impact of a skill-based cooking intervention compared to a standard cooking demonstration where recipes are simply provided to families.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria (Phase I):\n\n* be ≥18 years of age\n* have a child between the ages of 3 and 10 years-old\n* report being the primary caretaker and have the primary feeding responsibility of the child for dinner/supper\n* able to read, speak, and understand English\n* have transportation to the Medical Center\n* report their family including the child eats pre-prepared frozen food, restaurant food, fast food, or take-out for dinner ≥3 times per week\n* has a working telephone number\n* is able to attend the scheduled date and time of a focus group.\n\nInclusion Criteria (Phase II):\n\n* caretaker is ≥18 years of age\n* caretaker is overweight or obese (BMI≥25)\n* has a child between the ages of 3 and 10 years-old\n* report being the primary caretaker and have the primary feeding responsibility of the child for dinner/supper\n* caretaker is able to read, speak, and understand English\n* has transportation to the medical center and the instructional kitchen\n* does not plan to move out of the area before June 2015\n* reports their family including the child eats convenience food, restaurant food, fast food, or take-out for dinner ≥3 times per week\n* reports access to a kitchen\n* able to attend the scheduled date and time of the sessions.\n\nExclusion Criteria (Phase II):\n\n* the caretaker or child is currently participating in a weight loss program and/or taking weight loss medication\n* have a medical condition known to promote growth (e.g., Prader-Willi syndrome, Cushing's syndrome) or had gastric bypass surgery."}, 'identificationModule': {'nctId': 'NCT02202733', 'briefTitle': 'Skill-based Cooking Intervention to Reduce Eating Out', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'A Caretaker Cooking Skills Intervention to Reduce Eating Out', 'orgStudyIdInfo': {'id': '2013-5379'}, 'secondaryIdInfos': [{'id': 'Eating Out'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cooking', 'description': 'A skill-based cooking intervention for caretakers of an overweight/obese child aged 3-10 years.', 'interventionNames': ['Other: Cooking']}], 'interventions': [{'name': 'Cooking', 'type': 'OTHER', 'description': 'The aim is to test the feasibility of a skill-based cooking intervention to reduce the consumption of foods prepared away from home for the evening meal (e.g., pre-prepared frozen foods, restaurant foods, fast food, take-out), energy intake from evening meals, and parent/child weight status.', 'armGroupLabels': ['Cooking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}