Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-01-04 @ 5:14 PM
Study NCT ID:
NCT00558194
Status:
WITHDRAWN
Last Update Posted:
2018-03-14
First Post:
2007-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment (Part 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of funds', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-12', 'studyFirstSubmitDate': '2007-11-13', 'studyFirstSubmitQcDate': '2007-11-13', 'lastUpdatePostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight Loss', 'timeFrame': '12 Months'}], 'secondaryOutcomes': [{'measure': 'Internal disinhibition as measured by the Eating Inventory', 'timeFrame': '12 Months'}, {'measure': 'Physical activity as measured by the Paffenbarger', 'timeFrame': '12 months'}, {'measure': 'Dietary intake as measured by the Block Food Frequency Questionnaire', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Weight loss'], 'conditions': ['Overweight', 'Obesity']}, 'descriptionModule': {'briefSummary': 'Behavioral weight loss, the current treatment of choice for moderate obesity, achieves impressive short term results, however, weight regain following treatment is a major problem. Over 50% of participants in behavioral weight loss programs report difficulty with internal antecedents to unhealthy weight control behaviors and this difficulty is associated with weight regain following treatment. Current treatment approaches do not adequately address these antecedents. The aim of this series of studies is to develop, implement, and evaluate a behavioral weight loss program modified to provide participants with skills to deal effectively with affective and cognitive difficulties. The study targets men and women with BMI of 27-40 who self-report difficulty with emotional and/or cognitive antecedents to unhealthy weight control behaviors. The study will randomize 120 participants to receive 12 months of standard behavioral therapy for weight loss or standard behavioral treatment plus affective and cognitive skills training. The long-term goal of this research is to improve the weight loss maintenance outcomes of behavioral weight loss programs by addressing affective and cognitive antecedents to unhealthy weight control behaviors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 21 and 70 years\n* Body mass index between 27 and 40\n* Score 5 or above on the internal disinhibition scale of the Eating Inventory\n\nExclusion Criteria:\n\n* Are currently participating in a weight loss program and/or are taking a weight loss medication or lost greater than or equal to 5% of body weight during the past six months\n* Are pregnant, lactating, less than 6 months postpartum or plan to become pregnant during the time frame of the investigation\n* Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.'}, 'identificationModule': {'nctId': 'NCT00558194', 'briefTitle': 'Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment (Part 2)', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment', 'orgStudyIdInfo': {'id': 'K23 DK73536-2'}, 'secondaryIdInfos': [{'id': 'K23DK073536', 'link': 'https://reporter.nih.gov/quickSearch/K23DK073536', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Standard behavioral weight loss treatment with cognitive and affective skills training', 'interventionNames': ['Behavioral: Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Standard behavioral weight loss treatment', 'interventionNames': ['Behavioral: Standard Behavioral Weight Loss Treatment']}], 'interventions': [{'name': 'Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills Training', 'type': 'BEHAVIORAL', 'description': '12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment', 'armGroupLabels': ['1']}, {'name': 'Standard Behavioral Weight Loss Treatment', 'type': 'BEHAVIORAL', 'description': '12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Weight Control and Diabetes Research Center, The Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Heather M. Niemeier, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Miriam Hospital/The Warren Alpert Medical School of Brown U niversity'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}