Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-01-05 @ 9:58 AM
Study NCT ID:
NCT04311450
Status:
COMPLETED
Last Update Posted:
2022-10-26
First Post:
2020-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral Weight Loss Treatment for Individuals With Food Addiction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073932', 'term': 'Food Addiction'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2020-03-11', 'studyFirstSubmitQcDate': '2020-03-16', 'lastUpdatePostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight (e.g., change in percent weight loss)', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Food addiction (change in food addiction scores)', 'timeFrame': 'Up to 12 weeks', 'description': 'Yale Food Addiction Scale scores will be assessed by self-report (range of scores 0-7, higher score reflect greater food addiction symptoms)'}], 'secondaryOutcomes': [{'measure': 'Food Craving (change in food craving scores)', 'timeFrame': 'Up to 8 weeks', 'description': 'Food Craving Inventory scores will be assessed by self-report (range of score 0-185, higher scores reflect greater food cravings).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Food Addiction', 'Overweight and Obesity', 'Weight Loss']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to examine how well an existing weight loss treatment works for individuals with food addiction. Treatment will consist of a preliminary 12-week RCT pilot of the feasibility and effectiveness of behavioral weight loss (BWL) compared to a waitlist control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 25-50 kg/m2\n* Meets criteria for Food Addiction (based on the self-report score from the Yale Food Addiction Scale)\n* Available for the duration of the treatment (3 months)\n* Read, comprehend, and write English at a sufficient level to complete study-related materials.\n* Availability of internet to participate in study interventions (i.e., electronic SMART scales)\n\nExclusion Criteria:\n\n* Co-existing psychiatric condition that requires hospitalization or more intensive treatment (e.g., bipolar mood disorders, psychotic illnesses, severe depression).\n* Reports active suicidal or homicidal ideation\n* Current anorexia or bulimia nervosa\n* Endorsing current or history of heart trouble/chest pain.\n* Breast-feeding or pregnant, or planning to become pregnant during the study.\n* History of stroke or myocardial infarction.\n* Current or recent (within 12 months) drug or alcohol dependence\n* Currently receiving effective treatment for eating or weight loss, including individual who received bariatric surgery within the past five years\n* Currently participating in another clinical study.'}, 'identificationModule': {'nctId': 'NCT04311450', 'acronym': 'FA Pilot', 'briefTitle': 'Behavioral Weight Loss Treatment for Individuals With Food Addiction', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Behavioral Weight Loss Treatment for Individuals With Food Addiction', 'orgStudyIdInfo': {'id': '2000027229'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral Weight Loss', 'description': 'Behavioral: Participants randomized assigned to this arm will received 12 weeks of Behavioral Weight Loss (BWL) counseling.', 'interventionNames': ['Behavioral: Behavioral Weight Loss (BWL) counseling']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist Control', 'description': 'Waitlist Control: Participants assigned to this arm will attend follow-up visits to control for the effect of time. Following completion of post-treatment assessment participants in the waitlist control group will be offered an abbreviated BWL treatment.'}], 'interventions': [{'name': 'Behavioral Weight Loss (BWL) counseling', 'type': 'BEHAVIORAL', 'description': 'This therapy is a weekly treatment which focuses on making gradual and modest lifestyle changes with goals of establishing regular patterns of eating, setting weekly goals, decreasing caloric intake, developing coping skills, and increasing physical activity.', 'armGroupLabels': ['Behavioral Weight Loss']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}