Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT05177705
Status:
COMPLETED
Last Update Posted:
2025-07-08
First Post:
2021-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Intersection Between Loss of Control Eating and Obesity: The Role of Restriction and Food Reinforcement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D002032', 'term': 'Bulimia'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006963', 'term': 'Hyperphagia'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2021-12-10', 'studyFirstSubmitQcDate': '2021-12-29', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in zBMI', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in zBMI from baseline to 12 month follow-up'}], 'secondaryOutcomes': [{'measure': 'Change in body fat percentage', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in percent body fat from baseline to 12 month follow-up'}, {'measure': 'Impact of parental restriction of a High Energy Dense (HED) food on Loss of Control (LOC) eating.', 'timeFrame': 'Baseline', 'description': 'To examine change in energy intake and macronutrient composition during LOC test meal between parental restriction condition and parental non-restriction condition.'}, {'measure': 'Association between relative reinforcing value of high energy dense foods and LOC', 'timeFrame': 'Baseline', 'description': 'Relationships will be examined between RRV and both self-reported LOC eating and intake (calories, macronutrient distribution) in the LOC test meal.'}, {'measure': 'Relationship between self-reported LOC eating and consumption during LOC test meal', 'timeFrame': 'Baseline', 'description': 'Responses between self-reported feelings of LOC and intake (calories, macronutrient distribution) will be compared.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Relative Reinforcing Value', 'Obesity Risk', 'Children', 'Loss of Control', 'Restriction'], 'conditions': ['Pediatric Obesity', 'Nutrition Disorders', 'Binge Eating', 'Body Weight']}, 'descriptionModule': {'briefSummary': 'This study aims to determine the relationships among loss of control eating, restriction, relative reinforcing value of high energy-dense food, and obesity risk. In order to achieve this aim, the investigators will follow children over the course of a year, obtaining behavioral and observational measurements, in addition to a two-week restricted access and two week non-restricted access period.', 'detailedDescription': 'The study will be mostly observational but will also include a randomized, cross-over design (the restricted access paradigm). The investigators will recruit children at risk for obesity in Erie County, New York (N=100, 50 boys, 50 girls). The study will include 4 visits at baseline and follow-up visits at 6 and 12 months. At the first visit, the participants will complete consent, height/weight/body fat, questionnaires, and complete a delayed discount task and the relative reinforcing value task. The participants will be randomized to have two weeks of restricted access first or two weeks of non-restricted access first, and then will come into the laboratory to do the loss of control test meal. Then they will have a one-week washout period, and will then complete the other two weeks of restricted/not restricted access. Following this, they will complete the loss of control test meal again. At the follow-up visits, participants will come into the laboratory to have their height/weight/body fat measured, complete questionnaires, and complete the delayed discounting task, food reinforcement and loss of control test meals. Participants will be compensated for their time after each visit. The details of the measures and procedures are outlined below.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children (male and female) ages 8-11\n* At risk for obesity or with obesity (defined as either having a BMI percentile that classifies the child as having overweight-BMI \\>85th percentile but \\<99th OR one + biological parent with overweight/obesity-BMI \\>25)\n* Rating of neutral or higher for 50% of the study foods\n* Consumption of one of the study foods at least twice/week\n\nExclusion Criteria:\n\n* Children below age 8 or above age 11\n* Not at risk for obesity (defined as having a BMI percentile that classifies the child as having normal weight-BMI \\<85th percentile without having a parent with overweight or obesity)\n* Allergic to study foods\n* Dislike of study foods (Less than 50% of the study foods rated neutral or higher)\n* Does not consume at least one study food at least twice/week\n* Current diagnosis of a clinical eating disorder (ED)\n* Use of medications known to affect appetite (Ritalin, Adderall, Concerta, Wellbutrin, Prednisone, etc)\n* Unwillingness to complete study visits'}, 'identificationModule': {'nctId': 'NCT05177705', 'briefTitle': 'The Intersection Between Loss of Control Eating and Obesity: The Role of Restriction and Food Reinforcement', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'The Intersection Between Loss of Control Eating and Obesity: The Role of Restriction and Food Reinforcement', 'orgStudyIdInfo': {'id': 'STUDY00002806'}, 'secondaryIdInfos': [{'id': 'K01DK120778', 'link': 'https://reporter.nih.gov/quickSearch/K01DK120778', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral restriction', 'description': 'In the restriction period participants will have their preferred (chosen after doing a preference task, including liking) food and similar alternatives restricted by their parent for 2 weeks. In the structured intake period period, participants and their parents will be given several portions of the preferred food (chosen after doing a preference task, including liking) and will consume it throughout the two-week period.', 'interventionNames': ['Behavioral: Restricted access task']}], 'interventions': [{'name': 'Restricted access task', 'type': 'BEHAVIORAL', 'description': 'In the restriction period participants will have their preferred (chosen after doing a preference task, including liking) food and similar alternatives restricted by their parent for 2 weeks. In the no restricted period, participants and their parents will be given several portions of the preferred food and will consume it throughout the two-week period.', 'armGroupLabels': ['Behavioral restriction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14214', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'State University of New York at Buffalo, South Campus', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Katherine Balantekin, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Associate Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Katherine Balantekin', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}