Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-01-01 @ 4:42 AM
Study NCT ID:
NCT03962205
Status:
COMPLETED
Last Update Posted:
2021-06-30
First Post:
2019-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Weight Loss and Psychological Well-being in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D003863', 'term': 'Depression'}], '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'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-27', 'studyFirstSubmitDate': '2019-05-16', 'studyFirstSubmitQcDate': '2019-05-22', 'lastUpdatePostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in psychosocial profile', 'timeFrame': 'Baseline, 4 months,10 months,16 months', 'description': 'It will be measured with the PsychoSocial Index (PSI). PSI is a 55-item self-rating scale, divided into 5 domains: 1) Sociodemographic and clinical data (12 questions on medical and demographic information); 2) Stress subscale (17 yes/no questions) with a score ranging from 0 to 17 (a higher score indicates greater stress); 3) Well-being subscale (6 yes/no questions) with a score ranging from 0 to 6 (a higher score indicates greater psychological well-being); 4) Psychological distress (15 four-point questions ranging from 0 to 3) with a total score from 0 to 45 (a higher score indicates greater psychological distress); 5) Abnormal Illness Behavior (3 four-point questions from 0 to 3) with a total score ranging from 0 to 9 (a higher score indicates more severe abnormal illness behavior). Finally, PSI includes one 4-point question on self-perceived quality of life, with a score from 0 to 4 (a higher score indicates better quality of life).'}, {'measure': 'Change in motivation for weight change', 'timeFrame': 'Baseline, 4 months,10 months,16 months', 'description': 'It will be measured by the Goal Related Weight Questionnaire (GRWQ), which asks the respondents to self-report their dream, happy, acceptable, and disappointed weight in kilograms in the first part (4 items) and to indicate to which extent they expect weight loss to impact various aspects of their psycho-social and health-related functioning, with each item scored from 1 (extremely negative) to 10 (extremely positive), in the second part (21 items).'}], 'primaryOutcomes': [{'measure': '4-month Change in body weight in kg', 'timeFrame': 'Baseline, 4 months', 'description': '4-month average change in body weight (kg) from baseline to 4 months. Weight will be measured with a standard balance beam scale with the participant in a lightweight clothing.'}, {'measure': '4-month Change in body weight in %', 'timeFrame': 'Baseline, 4 months', 'description': '4-month average change in body weight as a percentage of start weight'}, {'measure': '10-month change in body weight in kg', 'timeFrame': 'Baseline, 10 months', 'description': '10-month average change in body weight (kg) from baseline to 10 months.'}, {'measure': '10-month change in body weight in %', 'timeFrame': 'Baseline, 10 months', 'description': '10-month average change in body weight as a percentage of start weight'}, {'measure': '16-month change in body weight in kg', 'timeFrame': 'Baseline, 16 months', 'description': '16-month average change in body weight (kg)'}, {'measure': '16-month change in body weight in %', 'timeFrame': 'Baseline, 16 months', 'description': '16-month average change in body weight as a percentage of start weight'}, {'measure': 'Change in Body mass Index (BMI)', 'timeFrame': 'Baseline, 4 months,10 months,16 months', 'description': 'It will be computed as body weight (kg) divided by the square of height (m²).'}], 'secondaryOutcomes': [{'measure': 'Change in psychological well-being', 'timeFrame': 'Baseline, 4 months,10 months,16 months', 'description': 'It will be measured with the Psychological WellBeing scale, a 42-item self-rating scale, which includes six dimensions: self-acceptance, positive relations with others, autonomy, environmental mastery, purpose in life and personal growth. The respondents are asked to indicate on a 6-likert scale the extent to which they agree with each statement. Each dimension may range from 7-42, with higher scores indicating greater psychological well-being.'}, {'measure': 'Change in the prevalence of depression', 'timeFrame': 'Baseline, 4 months,10 months,16 months', 'description': 'It will be measured by well-trained researcher with The Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders - 5th edition (SCID-5-CV).'}, {'measure': 'Change in the prevalence of demoralization', 'timeFrame': 'Baseline, 4 months,10 months,16 months', 'description': 'It will be measured by well-trained researchers with The Diagnostic Criteria for Psychosomatic Research-Revised Semi-Structured Interview- Revised (DCPR-R)'}, {'measure': 'Change in psychological distress', 'timeFrame': 'Baseline, 4 months,10 months,16 months', 'description': 'It will be measured by the Symptom Questionnaire (SQ), a 92-item self-rating instrument with dichotomous responses divided into 4 dimensions: depression, anxiety, somatization and hostility/irritability. Each dimension consists in a symptom sub-scale including 17 questions and a well being one with 6 questions. Scores may range from 0 to 17 for each symptom sub-scale and from 0 to 6 for each well-being sub-scale. For each dimension, higher scores indicate more severe psychological distress.'}, {'measure': 'Change in lifestyle', 'timeFrame': 'Baseline, 4 months,10 months,16 months', 'description': 'It will be measured with GOSPEL (GlObal Secondary Prevention strategiEs to Limit event recurrence after myocardial infarction - GOSPEL study) questionnaire, a 32-item self-rating instrument for the assessment of physical activity levels, eating habits, and stress levels used among patients who need to change their lifestyle.\n\nThe subscale on physical activity includes eight 4-point items with a total score ranging from 0 (poor/absent physical activity) to 20 (very high physical activity).\n\nThe subscale on eating habits consists of ten 4-point items regarding Mediterranean diet based on the frequency of healthy food consumption, with a total score ranging from 0 (worst) to 30 (best). Three additional 4-point items on eating behavior are also included: their total score may range from 0 (bad dietary behavior) to 9 (healthy dietary behavior).\n\nThe subscale on stress management includes seven 4-point items which total score may range from 0 (inadequate) to 21 (optimal).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obese patients', 'psychological well being', 'weight loss', 'depression', 'psychological distress', 'life-style intervention', 'demoralization'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '27043240', 'type': 'BACKGROUND', 'citation': 'Fava GA. Well-Being Therapy: Current Indications and Emerging Perspectives. Psychother Psychosom. 2016;85(3):136-45. doi: 10.1159/000444114. Epub 2016 Apr 5. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The goal of the proposed research is to assess the effects of a sequential combination of lifestyle and well-being intervention on weight loss and psychological well-being. It is hypothesized that psychological well-being promotion as an adjunct to life-style intervention will outperform life style intervention alone in promoting weight loss and psychological well-being in obese individuals.', 'detailedDescription': "The present study is a longitudinal, single blind, randomized controlled pilot trial. The participants will be recruited at the Center of Metabolism Diseases and Clinical Dietetics of Sant'Orsola Hospital in Bologna, directed by Prof. Giulio Marchesini Reggiani, after approval of the Ethics Committee of Azienda Ospedaliero-Universitaria of Bologna.\n\nPatients attending the Center of Metabolism Diseases and Clinical Dietetics during the enrollment period will be screened for inclusion and exclusion criteria by care coordinators or clinicians. Eligible patients will be required to sign the informed consent form and the consent form for personal data processing. The researchers will be in charge of explaining the project to make sure that it is fully understood by the patients.\n\nDuring the first 3 months, all the participants will undergo a behavioral program focusing on lifestyle modification. The participants who accomplish the program for life-style modification will be randomly assigned to either the control group or the experimental group. Generalized block randomization will be carried out by a computer program (the Random Allocation Software 2.0), with an allocation ratio of 1:1.\n\nParticipants in the experimental group will receive a four-session intervention on psychological well-being. Each session will last one hour and will be offered weekly, based on the principles of Well-Being Therapy. Patients in the control group will only receive a treatment as usual (TAU), according to the instructions given by their clinicians. Data will be collected for each participant through questionnaires and interviews at baseline, at the end of the life-style intervention, at the end of the well-being intervention, and at 6 months of follow-up after the intervention. Given the nature of this study, it will not be possible for participants and treatment delivers to be blinded. Trained researchers, masked to the experimental allocation of patients, will perform measurements and analyses of the data to minimize potential bias."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obese (BMI ≥ 30)\n* aged ≥18 years\n* willing to participate in the study.\n\nExclusion Criteria:\n\n* inability to provide informed consent to participate in the study (i.e. psychotic or mentally impaired patients);\n* insufficient knowledge of Italian;\n* presence of a medical condition associated with unintentional weight loss or gain;\n* presence of major psychiatric illness and cognitive deficit;\n* participation in another weight-loss program;\n* use of medication for weight loss;\n* history of weight loss surgery or weight loss surgery scheduled during the last year or within 16 months from the beginning of the study;\n* being pregnant or intended pregnancy during the last year or within 16 months from the beginning of the study.'}, 'identificationModule': {'nctId': 'NCT03962205', 'briefTitle': 'Promoting Weight Loss and Psychological Well-being in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Bologna'}, 'officialTitle': 'Promoting Weight Loss and Psychological Well-being in Obese Patients: Combination of Behavioral Life Style and Well-Being Intervention', 'orgStudyIdInfo': {'id': 'PWlPwb-OB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavioral life-style and well-being intervention', 'description': 'Participants will receive 12 group-based 2-hour weekly sessions for life-style modification and then 4 group-based 2-hour weekly sessions of the well-being intervention in addition to the treatment as usual.', 'interventionNames': ['Behavioral: cognitive-behavioral life style intervention', 'Behavioral: wellbeing intervention', 'Other: treatment as usual']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cognitive Behavioral life-style intervention', 'description': 'Participants will receive 12 group-based 2-hour weekly sessions for life-style modification in addition to the treatment as usual.', 'interventionNames': ['Behavioral: cognitive-behavioral life style intervention', 'Other: treatment as usual']}], 'interventions': [{'name': 'cognitive-behavioral life style intervention', 'type': 'BEHAVIORAL', 'description': 'Cognitive Behavioral life-style modification: The intervention will be composed of 12 weekly sessions. Each session will last about two hours and will be administered in a group setting (maximum 20 participants). During the first two sessions, a clinician will introduce the program to the participants and motivate them to make life-style changes.In the next eight sessions a dietician will provide participants with basics of nutrition and will coach them to use a structured diary to monitor their eating behavior and physical activity. Next, a physician will introduce to the patients various weight loss surgeries in terms of the adverse events, indications and effects of each option.The last session will be held by a psychologist and will focus on providing participants with useful strategies to promote healthy eating habits and physical activity, including problem solving and goal setting.', 'armGroupLabels': ['Cognitive Behavioral life-style and well-being intervention', 'Cognitive Behavioral life-style intervention']}, {'name': 'wellbeing intervention', 'type': 'BEHAVIORAL', 'description': "This program will consist of 4 weekly group-based sessions and each meeting will last about two hours. During the sessions, participants will be coached how to self-monitor their well-being episodes in everyday life, especially those associated with life-style change, by means of a structured diary. Patients will be then ecounraged to discuss their well-being experiences during group sessions, focusing on dysfunctional thoughts/beliefs interrupting them, fostering the identification of more functional thoughts. The psychologist will also teach them how to promote well-being situations through behavioral exercises and will introduce to the participants relevant psychological well-being dimensions (based on Carol Ryff's multidimensional model) associated with patients' experiences emerged during the treatment.", 'armGroupLabels': ['Cognitive Behavioral life-style and well-being intervention']}, {'name': 'treatment as usual', 'type': 'OTHER', 'description': 'The treatment as usual will involve any recommendation given to the participants by their physicians, including diet, physical activity and medication.', 'armGroupLabels': ['Cognitive Behavioral life-style and well-being intervention', 'Cognitive Behavioral life-style intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': "SSD Malattie del Metabolismo e Dietetica Clinica Policlinico Sant'Orsola- Malpighi", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Chiara Rafanelli, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Bologna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bologna', 'class': 'OTHER'}, 'collaborators': [{'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ordinary Professor', 'investigatorFullName': 'Chiara Rafanelli', 'investigatorAffiliation': 'University of Bologna'}}}}