Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 10:49 PM
Study NCT ID:
NCT05090293
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2021-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Weight Loss Outcomes Through Body Image Enhancement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2021-09-21', 'studyFirstSubmitQcDate': '2021-10-11', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Weight', 'timeFrame': 'Baseline (pre-intervention) and 14 weeks (post-intervention)', 'description': 'Changes in weight loss'}, {'measure': 'Comparison of Body Fat Mass', 'timeFrame': 'Baseline (pre-intervention) and 14 weeks (post-intervention)', 'description': 'Changes in body fat mass'}, {'measure': 'Comparison of Blood Pressure', 'timeFrame': 'Baseline (pre-intervention) and 14 weeks (post-intervention)', 'description': 'Changes in systolic blood pressure'}, {'measure': 'Comparison of Blood Pressure', 'timeFrame': 'Baseline (pre-intervention) and 14 weeks (post-intervention)', 'description': 'Changes in diastolic blood pressure'}, {'measure': 'Comparison of Blood Pressure', 'timeFrame': 'Baseline (pre-intervention) and 14 weeks (post-intervention)', 'description': 'Changes in resting heart rate'}, {'measure': 'Comparison of Physical Activity Engagement', 'timeFrame': 'Baseline (pre-intervention) and 14 weeks (post-intervention)', 'description': 'Increase in self-reported physical activity engagement'}, {'measure': 'Comparison of Health Related Quality of Life', 'timeFrame': 'Baseline (pre-intervention) and 14 weeks (post-intervention)', 'description': 'Increase in self-reported health related quality of life'}, {'measure': 'Comparison of Body Image', 'timeFrame': 'Baseline (pre-intervention) and 14 weeks (post-intervention)', 'description': 'Changes in attitudinal and perceptual body image'}], 'secondaryOutcomes': [{'measure': 'Comparison of Interoceptive Awareness', 'timeFrame': 'Baseline (pre-intervention) and 14 weeks (post-intervention)', 'description': 'Changes in the ability to identify and respond appropriately to internal bodily signals'}, {'measure': 'Comparison of General Self-Efficacy', 'timeFrame': 'Baseline (pre-intervention) and 14 weeks (post-intervention)', 'description': 'Changes in self-perception of ability and competence to perform effectively across different tasks and situations'}, {'measure': 'Comparison of Dieting Self-Efficacy', 'timeFrame': 'Baseline (pre-intervention) and 14 weeks (post-intervention)', 'description': 'Changes in self-perception of adequately responding to scenario-based eating temptations'}, {'measure': 'Comparison of Exercising Self-Efficacy', 'timeFrame': 'Baseline (pre-intervention) and 14 weeks (post-intervention)', 'description': 'Changes in self-perception of belief in ability to continue exercising despite setbacks'}, {'measure': 'Comparison of Fear of Negative Evaluation', 'timeFrame': 'Baseline (pre-intervention) and 14 weeks (post-intervention)', 'description': 'Changes in self-reported apprehension about negative evaluations by others'}, {'measure': 'Comparison of Motivation to Engage in Physical Activity', 'timeFrame': 'Baseline (pre-intervention) and 14 weeks (post-intervention)', 'description': 'Changes in self-reported motivation to engage in physical activity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'The study will examine if a standard group-delivered cognitive behavioral lifestyle intervention for weight loss can be improved via the incorporation of a novel body image intervention designed to address body image and improve weight loss outcomes in a sample of women with overweight/obesity.', 'detailedDescription': "Weight loss is associated with improved morbidity and mortality in people with overweight/obesity. Lifestyle-focused interventions reliably produce modest weight loss. While some comprehensive multidisciplinary weight management interventions include behavioral and psychosocial aspects of behavior change, including brief body image education, few have focused substantially on body image as a potentially salient influence on motivation and/or successful outcomes. Body image is an individual's perception of their physical self. A common psychosocial correlate of obesity is body dissatisfaction, and research has shown that individuals with obesity are more often dissatisfied with their bodies than individuals without obesity. Multiple studies suggest that improving body image might enhance eating self-regulation during weight management interventions and engagement in physical activity. Additionally, negative body image has been associated with detrimental health outcomes, such as emotional eating and avoidance of physical activity. Although body image has been addressed in the context of obesity and weight management, it is often done in a cursory manner. To date, no weight loss programs have attempted to develop a novel body image intervention that specifically targets the necessary dichotomy between body acceptance and expectable desire for body changes in a weight loss program. As such, the investigators will examine if a standard group-delivered cognitive behavioral lifestyle intervention for weight loss can be improved via the incorporation of a novel body image intervention designed to address body image and improve weight loss outcomes."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18 and older\n* Sex: Female\n* BMI of 25 kg/m2 or greater\n\nExclusion Criteria:\n\n* Participants unable or unwilling to provide informed consent\n* Participants who are pregnant or planning to become pregnant over the next 4 months\n* Participants who are breastfeeding or planning to breastfeed over the next 4 months\n* Participants who have received a diagnosis of diabetes (type I or II)\n* Participants who been told NOT to lose weight or exercise for any reason by a healthcare provider\n* Participants who currently have psychiatric illnesses (e.g., Psychosis, schizophrenia, bipolar disorder or severe depression/anxiety)\n* Participants who currently have persistent suicidal thoughts or have attempted suicide in the last year\n* Participants with a history of diagnosed eating disorders such as bulimia nervosa or anorexia nervosa.'}, 'identificationModule': {'nctId': 'NCT05090293', 'briefTitle': 'Optimizing Weight Loss Outcomes Through Body Image Enhancement', 'organization': {'class': 'OTHER', 'fullName': 'Texas Tech University'}, 'officialTitle': 'Optimizing Weight Loss Outcomes Through Body Image Enhancement', 'orgStudyIdInfo': {'id': 'TTUIRB2021-470'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lifestyle Intervention (LI)', 'description': 'Participants will receive a standard, 12-week, group-delivered cognitive behavioral lifestyle intervention for weight loss.', 'interventionNames': ['Behavioral: Lifestyle Intervention (LI)']}, {'type': 'EXPERIMENTAL', 'label': 'Lifestyle Intervention with Body Image Treatment (LIBI)', 'description': 'Participants will receive a standard, 12-week, group-delivered cognitive behavioral lifestyle intervention for weight loss supplemented with a novel body image intervention designed to address body image issues in the context of weight loss.', 'interventionNames': ['Behavioral: Experimental: Lifestyle Intervention with Body Image Treatment (LIBI)']}], 'interventions': [{'name': 'Experimental: Lifestyle Intervention with Body Image Treatment (LIBI)', 'type': 'BEHAVIORAL', 'description': 'A body image protocol designed to improve outcomes in a group-delivered multidisciplinary weight loss program by addressing body acceptance within a context of positive behavior change and utilizing existing body discomfort and re-purposing it as an agent of motivation.', 'armGroupLabels': ['Lifestyle Intervention with Body Image Treatment (LIBI)']}, {'name': 'Lifestyle Intervention (LI)', 'type': 'BEHAVIORAL', 'description': 'A multidisciplinary, group-delivered, multidisciplinary weight loss program addressing various lifestyle factors impacting weight loss.', 'armGroupLabels': ['Lifestyle Intervention (LI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79409', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech University - Department of Nutritional Sciences', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '79410', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Nutrition & Metabolic Health Initiative', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}], 'overallOfficials': [{'name': 'Martin Binks, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Tech University- Department of Nutritional Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Tech University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Martin Binks', 'investigatorAffiliation': 'Texas Tech University'}}}}