Ignite Creation Date:
2025-12-24 @ 1:52 PM
Ignite Modification Date:
2026-01-04 @ 9:52 AM
Study NCT ID:
NCT02579395
Status:
COMPLETED
Last Update Posted:
2018-03-21
First Post:
2015-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Couples-based Approach for Increasing Physical Activity Among Adults With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-19', 'studyFirstSubmitDate': '2015-10-09', 'studyFirstSubmitQcDate': '2015-10-15', 'lastUpdatePostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-Reported Physical Activity via IPAQ', 'timeFrame': 'Baseline, 3 weeks, 6 weeks', 'description': 'Participants will self-report their physical activity over the past week using the International Physical Activity Questionnaire (IPAQ)'}, {'measure': 'Objective Physical Activity via accelerometer', 'timeFrame': 'Basline, 6 weeks', 'description': 'Participants will wear Actigraph Accelerometers'}], 'secondaryOutcomes': [{'measure': 'Physical Activity Self-Efficacy via a self efficacy scale', 'timeFrame': 'Baseline, 3 weeks, 6 weeks', 'description': 'Physical activity self-efficacy will be measured using the self-efficacy for exercise scale (SEE; Resnick \\& Jenkins, 2000). This 9-item, self-report scale assesses participant\'s confidence that they could exercise three times per week for 20 minutes under various circumstances (e.g. "you had to exercise alone"; "you felt tired"). Respondents are asked to rate items on a scale from 1, (not at all confident), to 10 (extremely confident).'}, {'measure': 'Physical Activity Partner Investment Scale', 'timeFrame': 'Baseline, 3 weeks, 6 weeks', 'description': 'The Physical Activity Partner Investment Scale assesses the degree to which the partner in a couple defines the patient engaging in regular physical activity as a shared responsibility as well as the degree to which they are taking action to address barriers to the patient engaging in physical activity . The 9 items selected were modified to be specific to engaging in regular physical activity. Participants are asked to rate their agreement each item on a scale from 1 (strongly disagree) to 7 (strongly agree). Example items include "If/when my partner decides to engage in regular physical activity , the responsibility will be his or hers alone.", "My partner and I are able to have useful discussions about how to engage in regular physical activity ." and "In the long run, my partner and I are able to work together toward helping one or both of us maintain a regular physical activity routine".'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Collaborative Implementation Intentions', 'Individual Implementation Intentions', 'Information Only Control Condition']}, 'descriptionModule': {'briefSummary': "In a 6-week experimental design, up to 90 adult couples in which one partner has Type 2 Diabetes (T2D) will be randomly assigned to either the collaborative implementation intentions (Collaborative IIs), the Individual Implementation Intentions (Individual IIs) condition, or the control condition. As this is a pilot study, randomization for the experimental groups vs the control groups will occur at a 2:1 ratio. Thus, the experimental conditions will contain up to 36 participants and the control condition will contain up to 18 participants. Adults with T2D who are living with a romantic partner, not meeting current physical activity guidelines but able and willing to begin a new physical activity (PA) routine and their partners will be assessed at baseline, 3 weeks and 6 weeks after the experimental manipulation. Partners will report on their own investment in the patient's goal and patients will report on their own PA self-efficacy. Patient's PA will be measured through self-report, partner report and accelerometers for a week prior to each survey assessment. These specific aims are planned:\n\nAIM 1: Determine whether collaborative IIs for patient's PA lead to a greater increase in partner investment in partners of adults with T2D than do individual IIs or control.\n\nAIM 2: Determine whether collaborative IIs for patient's PA lead to a greater increase in patient PA self-efficacy in adults with T2D than do individual IIs or control.\n\nAIM 3: Determine whether collaborative IIs for patient's PA lead to a greater increase in patient PA in adults with T2D than do individual IIs or control."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 21 years of age\n* Able to read and understand English\n* Does not meet physical activity guidelines (\\< 150 minutes of moderate-vigorous exercise per week) for the last 3 months\\* (only required of one partner)\n* Diagnosed with Type 2 Diabetes\\* (only required of one partner)\n* Married or living with a romantic partner\n\nExclusion Criteria:\n\n* Medical or physical contraindications to participate in physical activity'}, 'identificationModule': {'nctId': 'NCT02579395', 'briefTitle': 'A Couples-based Approach for Increasing Physical Activity Among Adults With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'A Couples-based Approach for Increasing Physical Activity Among Adults With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '15-0601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'With spouse/romantic partner', 'interventionNames': ['Behavioral: Collaborative implementation Intentions']}, {'type': 'EXPERIMENTAL', 'label': 'Without spouse/romantic partner', 'interventionNames': ['Behavioral: Individual implementation Intentions']}, {'type': 'OTHER', 'label': 'Control', 'description': 'No Intervention', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'Collaborative implementation Intentions', 'type': 'BEHAVIORAL', 'description': 'With spouse/romantic partner', 'armGroupLabels': ['With spouse/romantic partner']}, {'name': 'Individual implementation Intentions', 'type': 'BEHAVIORAL', 'description': 'Without spouse/romantic partner', 'armGroupLabels': ['Without spouse/romantic partner']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Jennalee S Wooldridge, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}