Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-02-20 @ 3:31 PM
Study NCT ID:
NCT05420051
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2022-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Boosting Emotional Well-being and Happiness in Outpatients Living With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080032', 'term': 'Psychology, Positive'}, {'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D011584', 'term': 'Psychology'}, {'id': 'D001525', 'term': 'Behavioral Sciences'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental 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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2022-06-10', 'studyFirstSubmitQcDate': '2022-06-10', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 8, 24, and 52 weeks', 'timeFrame': 'Measured for 7 days at baseline, 8 weeks, 24, weeks, and 52 weeks', 'description': 'MVPA will be measured via an accelerometer and recorded in mean minutes/day.'}, {'measure': 'Change from Baseline Overall Activity at 8, 24, and 52 weeks', 'timeFrame': 'Measured for 7 days at baseline, 8 weeks, 24, weeks, and 52 weeks', 'description': 'Overall activity will be measured via an accelerometer and recorded in mean steps/day.'}, {'measure': 'Change from Baseline in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items) at 8, 24, and 52 weeks', 'timeFrame': 'Baseline, 8 weeks, 24 weeks, 52 weeks', 'description': 'The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with HF, will be used to measure positive affect (Range: 10-50). Higher scores indicate higher levels of positive affect.'}, {'measure': 'Change in optimism (Life Orientation Test - Revised [LOT-R])', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'Life Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Higher scores indicate higher levels of dispositional optimism.'}, {'measure': 'Change in depressive symptoms (Patient Health Questionnaire [PHQ-9])', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'The Patient Health Questionnaire-9 (PHQ-9) will be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-27). Higher scores indicate higher levels of depression.'}, {'measure': 'Change in anxiety (Hospital Anxiety and Depression Scale - anxiety subscale [HADS-A])', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale will be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of anxiety.'}, {'measure': 'Change in locus of control (Form C of the Multidimensional Health Locus of Control scale [MHLC Form C])', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'Locus of control will be measured using the 18-item Multidimensional Health Locus of Control scale \\[MHLC Form C\\]. Scores on this scale range from 6-36, with higher scores indicating greater internal health locus of control.'}, {'measure': 'Change in perceived social support (Multidimensional Scale of Perceived Social Support [MSPSS])', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'The MSPSS is a 12-item scale designed to measure perceived social support from three sources: Family, Friends, and a Significant Other. Scores on this scale range from 0-84, with higher scores indicating greater perceived social support.'}, {'measure': 'Change in exercise-related self-efficacy (Self-efficacy for Exercise Scale [SEE])', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': "The Self-efficacy for Exercise Scale will be used to measure exercise self-efficacy. This is a 9-item scale used to assess an individual's beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 20+ minutes per session in the future. Scores on this scale range from 0-90, with higher scores indicating greater self-efficacy for exercise."}, {'measure': 'Change in physical function (PROMIS 20-item Physical Function Short Form [PF-20])', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'The PROMIS 20-item short form (PF-20) will be used to assess physical function. Scores on this scale range from 20-100, with higher scores indicating greater physical function.'}, {'measure': 'Change in mental health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] mental component score)', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'The SF-12 mental component score will be used to assess mental health-related quality of life (Range: 0-100). Higher scores indicate higher levels of mental health-related quality of life.'}, {'measure': 'Change in physical health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] physical component score)', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'The SF-12 physical component score will be used to assess physical health-related quality of life (Range: 0-100). Higher scores indicate higher levels of physical health-related quality of life.'}, {'measure': 'Change in adherence to a diabetes diet (General diet items of the Summary of Diabetes Self-Care Activities [SDSCA])', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'Measured by the general diet items of the Summary of Diabetes Self-Care Activities (SDSCA), a well-validated measure of diabetes self-management that is associated with clinical outcomes (Range: 0-7). Higher scores indicate greater adherence.'}, {'measure': 'Change in adherence to fruits, vegetables, and low fat foods (Specific diet items of the Summary of Diabetes Self-Care Activities [SDSCA])', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'Measured by the specific diet items of the Summary of Diabetes Self-Care Activities (SDSCA), a well-validated measure of diabetes self-management that is associated with clinical outcomes (Range: 0-7). Higher scores indicate greater adherence.'}, {'measure': 'Change in exercise (Exercise items of the Summary of Diabetes Self-Care Activities [SDSCA])', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'Measured by the exercise items of the Summary of Diabetes Self-Care Activities (SDSCA), a well-validated measure of diabetes self-management that is associated with clinical outcomes (Range: 0-7). Higher scores indicate more exercise.'}, {'measure': 'Change in frequency of blood glucose testing (Blood glucose testing items of the Summary of Diabetes Self-Care Activities [SDSCA])', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'Measured by the blood glucose testing items of the Summary of Diabetes Self-Care Activities (SDSCA), a well-validated measure of diabetes self-management that is associated with clinical outcomes (Range: 0-7). Higher scores indicate more frequent blood glucose testing.'}, {'measure': 'Change in foot care (Foot care items of the Summary of Diabetes Self-Care Activities [SDSCA])', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'Measured by the foot care items of the Summary of Diabetes Self-Care Activities (SDSCA), a well-validated measure of diabetes self-management that is associated with clinical outcomes (Range: 0-7). Higher scores indicate more frequent foot care.'}, {'measure': 'Change in self-reported MVPA (International Physical Activity Questionnaire [IPAQ])', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'Measured by the self-report International Physical Activity Questionnaire (IPAQ). The measure assesses the types of intensity of physical activity that people do as part of their daily lives. Moderate and vigorous intensity activities will be converted to multiples of resting energy expenditure (MET) minutes per week.'}, {'measure': 'Change in self-reported sedentary time (International Physical Activity Questionnaire [IPAQ])', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'Measured by the self-report International Physical Activity Questionnaire (IPAQ). Measured in hours per day.'}, {'measure': 'Change in weight (kilograms)', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'Weight will be measured during study visits.'}, {'measure': 'Change in body mass index (kilograms per square meter)', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'Height and weight will be measured during study visits.'}, {'measure': 'Change in blood pressure (millimeters of mercury)', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'Blood pressure (diastolic and systolic) will be measured by trained nurses using a standardized protocol.'}, {'measure': 'Change in hemoglobin A1C (%)', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'Blood samples will be obtained at study visits.'}, {'measure': 'Change in low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol (milligrams per deciliter)', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'Blood samples will be obtained at study visits.'}, {'measure': 'Change in triglycerides (milligrams per deciliter)', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks', 'description': 'Blood samples will be obtained at study visits.'}], 'primaryOutcomes': [{'measure': 'Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 16 weeks', 'timeFrame': 'Measured for 7 days at baseline and 16 weeks', 'description': 'MVPA will be measured via an accelerometer and recorded in mean minutes/day.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline Overall Activity at 16 weeks', 'timeFrame': 'Measured for 7 days at baseline and 16 weeks', 'description': 'Overall activity will be measured via an accelerometer and recorded in mean steps/day.'}, {'measure': 'Change from Baseline in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items) at 16 weeks', 'timeFrame': 'Baseline, 16 weeks', 'description': 'The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with HF, will be used to measure positive affect (Range: 10-50). Higher scores indicate higher levels of positive affect.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The focus of this study is to test the efficacy of an 8-week, remotely delivered, positive-psychology-motivational interviewing (PP-MI) intervention, with additional twice weekly text messages for a total of 16 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 8 weeks), compared to MI-alone, in a randomized trial of 280 individuals with type 2 diabetes and low baseline physical activity.', 'detailedDescription': "The investigators are proposing a study that will focus on testing the efficacy of a PP-MI intervention, with additional twice text messages for a total of 16 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 8 weeks) in individuals with type 2 diabetes. The investigators will enroll 280 type 2 diabetes patients, who will take part in either an 8-week intervention (with 16 weeks of supplemental text messages) or an attention-matched, MI-alone condition.\n\nIn this project, the investigators hope to do the following:\n\n1. Examine the efficacy of an 8-week, phone-delivered PP-MI intervention for individuals with type 2 diabetes on physical activity-related outcomes, as compared to the MI-alone condition.\n2. Assess PP-MI's impact on psychological measures (e.g., positive affect \\[key secondary outcome\\]), diabetes self-care, function, glycemic control, and cardiometabolic risk, compared to MI alone.\n3. Examine causal mediation of PP-MI's effects on MVPA at 16 weeks by positive affect (primary hypothesized mediator) and other psychological/cognitive variables across our theoretical model.\n\nParticipants will be adult outpatients with type 2 diabetes. They will attend an in-person visit to provide informed consent and complete baseline outcome measures, then will wear an accelerometer to monitor their physical activity for one week to obtain information about baseline activity levels. Upon confirmation of low moderate to vigorous physical activity, participants will be randomized to receive the PP-MI intervention or the MI-alone intervention.\n\nParticipants in both groups will be provided a treatment manual, an activity tracker, and other treatment materials. The intervention will be introduced, and the first exercise will be assigned.\n\nParticipants will complete eight weekly phone sessions with a study trainer. The phone sessions primarily will include a review of the prior week's session content and a discussion of the rationale and assignment of the next week's exercise/assignment.\n\nParticipants will receive twice weekly text messages throughout the intervention (Weeks 1-8) and initial follow-up period (Weeks 9-16). In the PP-MI condition, these messages will focus on the PP activity and physical activity, while those in the MI-alone condition will focus on physical activity and other health behaviors. During Weeks 9-16, participants in the PP-MI condition will engage with twice weekly, automated, interactive text messages related to PP and physical activity, while those in the MI-alone condition will receive fixed text messages related to engagement in health behaviors.\n\nAt Weeks 8, 16, 24, and 52, participants will complete follow-up visits. One week prior to these visits, participants will be mailed an accelerometer and will wear it until their study visit. During these study visits, participants will complete outcome assessments and have a blood sample taken."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Type 2 Diabetes\n* Low physical activity (\\<150 minutes/week of moderate to vigorous physical activity)\n\nExclusion Criteria:\n\n* Cognitive deficits impeding a participant's ability to provide informed consent or participate\n* Medical conditions likely to lead to death within 6 months.\n* Pre-existing coronary artery disease\n* Moderate-severe depression (Patient Health Questionnaire-9 \\[PHQ-9\\] score ≥15)\n* Use of non-basal insulin\n* Inability to participate in physical activity due to another medical condition\n* Inability to receive text messages\n* Inability to read, write, or speak in English\n* Current participation in another intervention or program that has been designed to promote well-being or physical activity"}, 'identificationModule': {'nctId': 'NCT05420051', 'acronym': 'BEHOLD', 'briefTitle': 'Boosting Emotional Well-being and Happiness in Outpatients Living With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'A Novel Psychological-behavioral Intervention to Promote Physical Activity in Type 2 Diabetes', 'orgStudyIdInfo': {'id': '2022P000780'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Positive Psychology + Motivational Interviewing', 'description': "Each week, participants in the PP-MI intervention group will complete a PP activity and work towards a physical activity goal, then complete a phone session with a study trainer. Each phone session will include PP and goal setting portions. In the PP portion, the study trainer will (a) review the week's PP exercise, (b) discuss the rationale of the next week's PP exercise through a guided review of the PP-MI manual, and (c) assign the next week's PP exercise. In the goal-setting portion, the trainer will (a) review the participant's physical activity goal from the prior week, (b) discuss techniques for improving physical activity (e.g. tracking activity), and (c) help the participant to set a physical activity goal for the next week. Participants also will receive supplemental text messages throughout the 8 weeks of the intervention and during the initial follow-up period (Week 9-16).", 'interventionNames': ['Behavioral: Positive Psychology + Motivational Interviewing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Motivational Interviewing', 'description': "Each week, participants in the MI-alone group will complete an activity related to a health behavior (e.g., thinking about the pros and cons of changing the behavior), then complete a phone session with a study trainer. During the phone session, the trainer will (a) review the prior week's topic, (b) discuss techniques for improving adherence to health behaviors (e.g. tracking activity), and (c) problem-solve barriers and encourage the use of resources. Participants also will receive supplemental text messages throughout the 8 weeks of the intervention and during the initial follow-up period (Week 9-16).", 'interventionNames': ['Behavioral: Motivational Interviewing']}], 'interventions': [{'name': 'Positive Psychology + Motivational Interviewing', 'type': 'BEHAVIORAL', 'description': 'The 8-week PP-MI intervention focuses on enhancing well-being (through PP) and increasing physical activity (through MI). Each week, participants will complete a PP activity and work towards a physical activity goal, then complete a phone session with a study trainer. The PP portion of the program will focus on the cultivation of well-being through the performance of easy-to complete activities (e.g., using a strength in a new way) and review of the positive feelings they generate. The MI portion of the program will focus on assisting participants to improve physical activity levels, resolve ambivalence to behavior change, set realistic physical activity goals, problem-solve barriers, and identify resources to complete behavior change. Finally, participants will receive twice weekly text messages (for 16 weeks) to encourage completion of PP activities and engagement in physical activity.', 'armGroupLabels': ['Positive Psychology + Motivational Interviewing']}, {'name': 'Motivational Interviewing', 'type': 'BEHAVIORAL', 'description': 'The 8-week MI-alone intervention focuses on providing education and enhancing motivation to engage in health behaviors (through MI). Each week, participants will complete an activity related to a health behavior (e.g., consider the pros and cons of behavior change, set a health behavior goal), then complete a phone session with a study trainer. This program will focus on assisting participants to improve health behavior adherence (including physical activity), resolve ambivalence to behavior change, set realistic health behavior goals, problem-solve barriers, and identify resources to complete behavior change. Additional time in MI-alone phone sessions will be spent on review of core MI skills, problem-solving of barriers, and discussion of resources. Finally, participants will receive twice weekly text messages (for 16 weeks) to encourage engagement in health behaviors.', 'armGroupLabels': ['Motivational Interviewing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeff C Huffman, MD', 'role': 'CONTACT', 'email': 'jhuffman@mgh.harvard.edu', 'phone': '617-724-2910'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Jeff C Huffman, M.D.', 'role': 'CONTACT', 'email': 'jhuffman@partners.org', 'phone': '617-724-2910'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'This information will be shared prior to the end of the study funding period.', 'ipdSharing': 'YES', 'description': 'To promote sharing of study data with other researchers, we will create a deidentified study dataset. We will include both item-level and summary scores for each scale and will include data from the baseline, 8-week, 16-week, 24-week, and 52-week time points.', 'accessCriteria': 'Investigators who are interested in obtaining access to this information will be asked to submit a request to the principal investigator outlining the proposed use of the data and would need to agree to certain conditions (e.g., not attempting to identify individual participants, destroying data once the use of the data is complete) prior to obtaining access.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Cardiac Psychiatry Research Program', 'investigatorFullName': 'Jeff C. Huffman, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}