Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-04-08 @ 12:11 PM
Study NCT ID:
NCT02462057
Status:
COMPLETED
Last Update Posted:
2018-11-09
First Post:
2015-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Testing Different Messaging Approaches to Increase Activation of a HealthyFood Benefit in Adults With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Anjali.Gopalan@kp.org', 'phone': '510-891-3458', 'title': 'Anjali Gopalan', 'organization': 'Kaiser Permanente Northern California Division of Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control Arm', 'description': 'This arm will represent current practice. This group will receive no contact from the research team. They may receive information regarding the benefit from the Vitality marketing team during the intervention period and can enroll in the benefit at any time during the study period.', 'otherNumAtRisk': 737, 'otherNumAffected': 0, 'seriousNumAtRisk': 737, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Diabetes-specific', 'description': 'This group will receive a message which simply cites the two specific benefits of the eating more healthy foods for individuals with diabetes. This message contains a link to start the enrolment process.\n\nEmail message regarding the HealthyFood benefit', 'otherNumAtRisk': 753, 'otherNumAffected': 0, 'seriousNumAtRisk': 753, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Experience of Another Member', 'description': 'This group will receive a message that includes a quote from the perspective of a Vitality member with diabetes who uses the HealthyFood benefit. Given the need to standardise message content across study arms, the quote was written by the study team and not an actual member. The quote emphasizes the positive impact the benefit has had for the member-both the financial benefit, as well as the two specific diabetes health benefits.\n\nEmail message regarding the HealthyFood benefit', 'otherNumAtRisk': 766, 'otherNumAffected': 0, 'seriousNumAtRisk': 766, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Input From a Diabetes Expert', 'description': "This group will receive a message that includes a quote from a South African physician who specializes in diabetes. The quote emphasises the financial benefit and the two specific diabetes health benefits of the HealthyFood program included in the other messages. It concludes with the doctor's recommendation of the benefit for all individuals with diabetes.\n\nEmail message regarding the HealthyFood benefit", 'otherNumAtRisk': 701, 'otherNumAffected': 0, 'seriousNumAtRisk': 701, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Enhanced Active Choice', 'description': "This group will receive a message whose first portion is identical to those in the diabetes-specific message group. The second portion of the message differs in that instead of just asking recipients to click on the provided link if interested, the message asks people to choose and click on one of following possible responses:\n\n1. Yes! I want to active the HealthyFood benefit and get up to 25% cash back on the healthy food I buy at Pick n Pay or Woolworths\n2. No, I'd prefer not to activate and continue paying full price for my healthy food purchases\n\nEmail message regarding the HealthyFood benefit", 'otherNumAtRisk': 708, 'otherNumAffected': 0, 'seriousNumAtRisk': 708, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Enrollment in 10% Level of Benefit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '737', 'groupId': 'OG000'}, {'value': '753', 'groupId': 'OG001'}, {'value': '766', 'groupId': 'OG002'}, {'value': '701', 'groupId': 'OG003'}, {'value': '708', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': 'This arm will represent current practice. This group will receive no contact from the research team. They may receive information regarding the benefit from the Vitality marketing team during the intervention period and can enroll in the benefit at any time during the study period.'}, {'id': 'OG001', 'title': 'Diabetes-specific', 'description': 'This group will receive a message which simply cites the two specific benefits of the eating more healthy foods for individuals with diabetes. This message contains a link to start the enrolment process.\n\nEmail message regarding the HealthyFood benefit'}, {'id': 'OG002', 'title': 'Experience of Another Member', 'description': 'This group will receive a message that includes a quote from the perspective of a Vitality member with diabetes who uses the HealthyFood benefit. Given the need to standardise message content across study arms, the quote was written by the study team and not an actual member. The quote emphasizes the positive impact the benefit has had for the member-both the financial benefit, as well as the two specific diabetes health benefits.\n\nEmail message regarding the HealthyFood benefit'}, {'id': 'OG003', 'title': 'Input From a Diabetes Expert', 'description': "This group will receive a message that includes a quote from a South African physician who specializes in diabetes. The quote emphasises the financial benefit and the two specific diabetes health benefits of the HealthyFood program included in the other messages. It concludes with the doctor's recommendation of the benefit for all individuals with diabetes.\n\nEmail message regarding the HealthyFood benefit"}, {'id': 'OG004', 'title': 'Enhanced Active Choice', 'description': "This group will receive a message whose first portion is identical to those in the diabetes-specific message group. The second portion of the message differs in that instead of just asking recipients to click on the provided link if interested, the message asks people to choose and click on one of following possible responses:\n\n1. Yes! I want to active the HealthyFood benefit and get up to 25% cash back on the healthy food I buy at Pick n Pay or Woolworths\n2. No, I'd prefer not to activate and continue paying full price for my healthy food purchases\n\nEmail message regarding the HealthyFood benefit"}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The anticipated sample size of 3500 provided 80% power to detect a 3% pairwise difference between the proportions of participants who enrolled in HF with significance testing conducted at the Bonferroni-corrected significance level of 0.005 (0.05/10) to account for the 10 pairwise between-arm comparisons and pessimistically allowing for up to 10% further exclusions. The baseline monthly enrolment rate was estimated at ∼1%/month.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month from initial emailed messages', 'description': 'Rates of enrolment in 10% cash-back level (the most basic level, requires online activation only) of the HealthyFood Benefit amongst members with diabetes', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Arm', 'description': 'This arm will represent current practice. This group will receive no contact from the research team. They may receive information regarding the benefit from the Vitality marketing team during the intervention period and can enroll in the benefit at any time during the study period.'}, {'id': 'FG001', 'title': 'Diabetes-specific', 'description': 'This group will receive a message which simply cites the two specific benefits of the eating more healthy foods for individuals with diabetes. This message contains a link to start the enrolment process.\n\nEmail message regarding the HealthyFood benefit'}, {'id': 'FG002', 'title': 'Experience of Another Member', 'description': 'This group will receive a message that includes a quote from the perspective of a Vitality member with diabetes who uses the HealthyFood benefit. Given the need to standardise message content across study arms, the quote was written by the study team and not an actual member. The quote emphasizes the positive impact the benefit has had for the member-both the financial benefit, as well as the two specific diabetes health benefits.\n\nEmail message regarding the HealthyFood benefit'}, {'id': 'FG003', 'title': 'Input From a Diabetes Expert', 'description': "This group will receive a message that includes a quote from a South African physician who specializes in diabetes. The quote emphasises the financial benefit and the two specific diabetes health benefits of the HealthyFood program included in the other messages. It concludes with the doctor's recommendation of the benefit for all individuals with diabetes.\n\nEmail message regarding the HealthyFood benefit"}, {'id': 'FG004', 'title': 'Enhanced Active Choice', 'description': "This group will receive a message whose first portion is identical to those in the diabetes-specific message group. The second portion of the message differs in that instead of just asking recipients to click on the provided link if interested, the message asks people to choose and click on one of following possible responses:\n\n1. Yes! I want to active the HealthyFood benefit and get up to 25% cash back on the healthy food I buy at Pick n Pay or Woolworths\n2. No, I'd prefer not to activate and continue paying full price for my healthy food purchases\n\nEmail message regarding the HealthyFood benefit"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '791'}, {'groupId': 'FG001', 'numSubjects': '793'}, {'groupId': 'FG002', 'numSubjects': '812'}, {'groupId': 'FG003', 'numSubjects': '752'}, {'groupId': 'FG004', 'numSubjects': '758'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '737'}, {'groupId': 'FG001', 'numSubjects': '753'}, {'groupId': 'FG002', 'numSubjects': '766'}, {'groupId': 'FG003', 'numSubjects': '701'}, {'groupId': 'FG004', 'numSubjects': '708'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '46'}, {'groupId': 'FG003', 'numSubjects': '51'}, {'groupId': 'FG004', 'numSubjects': '50'}]}], 'dropWithdraws': [{'type': 'Left Vitality', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '35'}, {'groupId': 'FG004', 'numSubjects': '33'}]}, {'type': 'Joined HealthyFood Before Intervention', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '17'}]}]}], 'preAssignmentDetails': '5467 individuals were eligible in 1/2015. This sample was identified months before randomization to allow individuals time to learn about HF from other sources and enrol if interested. Prior to randomization, we excluded participants who joined HF of left Vitality since identification. This is why the initial and randomized samples are unequal.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '737', 'groupId': 'BG000'}, {'value': '753', 'groupId': 'BG001'}, {'value': '766', 'groupId': 'BG002'}, {'value': '701', 'groupId': 'BG003'}, {'value': '708', 'groupId': 'BG004'}, {'value': '3665', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Arm', 'description': 'This arm will represent current practice. This group will receive no contact from the research team. They may receive information regarding the benefit from the Vitality marketing team during the intervention period and can enroll in the benefit at any time during the study period.'}, {'id': 'BG001', 'title': 'Diabetes-specific', 'description': 'This group will receive a message which simply cites the two specific benefits of the eating more healthy foods for individuals with diabetes. This message contains a link to start the enrolment process.\n\nEmail message regarding the HealthyFood benefit'}, {'id': 'BG002', 'title': 'Experience of Another Member', 'description': 'This group will receive a message that includes a quote from the perspective of a Vitality member with diabetes who uses the HealthyFood benefit. Given the need to standardise message content across study arms, the quote was written by the study team and not an actual member. The quote emphasizes the positive impact the benefit has had for the member-both the financial benefit, as well as the two specific diabetes health benefits.\n\nEmail message regarding the HealthyFood benefit'}, {'id': 'BG003', 'title': 'Input From a Diabetes Expert', 'description': "This group will receive a message that includes a quote from a South African physician who specializes in diabetes. The quote emphasises the financial benefit and the two specific diabetes health benefits of the HealthyFood program included in the other messages. It concludes with the doctor's recommendation of the benefit for all individuals with diabetes.\n\nEmail message regarding the HealthyFood benefit"}, {'id': 'BG004', 'title': 'Enhanced Active Choice', 'description': "This group will receive a message whose first portion is identical to those in the diabetes-specific message group. The second portion of the message differs in that instead of just asking recipients to click on the provided link if interested, the message asks people to choose and click on one of following possible responses:\n\n1. Yes! I want to active the HealthyFood benefit and get up to 25% cash back on the healthy food I buy at Pick n Pay or Woolworths\n2. No, I'd prefer not to activate and continue paying full price for my healthy food purchases\n\nEmail message regarding the HealthyFood benefit"}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.9', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '55.2', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '55', 'spread': '10.8', 'groupId': 'BG002'}, {'value': '55.4', 'spread': '10', 'groupId': 'BG003'}, {'value': '56', 'spread': '10.6', 'groupId': 'BG004'}, {'value': '55.4', 'spread': '10.6', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}, {'value': '146', 'groupId': 'BG004'}, {'value': '729', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5467}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-13', 'studyFirstSubmitDate': '2015-05-30', 'resultsFirstSubmitDate': '2017-08-28', 'studyFirstSubmitQcDate': '2015-06-02', 'lastUpdatePostDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-13', 'studyFirstPostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment in 10% Level of Benefit', 'timeFrame': 'One month from initial emailed messages', 'description': 'Rates of enrolment in 10% cash-back level (the most basic level, requires online activation only) of the HealthyFood Benefit amongst members with diabetes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diet', 'Incentives', 'Messaging']}, 'referencesModule': {'references': [{'pmid': '27903559', 'type': 'DERIVED', 'citation': 'Gopalan A, Paramanund J, Shaw PA, Patel D, Friedman J, Brophy C, Buttenheim AM, Troxel AB, Asch DA, Volpp KG. Randomised controlled trial of alternative messages to increase enrolment in a healthy food programme among individuals with diabetes. BMJ Open. 2016 Nov 30;6(11):e012009. doi: 10.1136/bmjopen-2016-012009.'}]}, 'descriptionModule': {'briefSummary': "The Vitality HealthyFood benefit is a three-tiered incentive program designed to encourage healthier food choices amongst members of Discovery Health's Vitality program. Once enrolled in the benefit, participating members can receive 10%, 15%, or 25% cash-back on the healthy foods they purchase at selected grocers. And, while overall enrollment in the program is high, there is particular interest in increasing enrollment in the benefit amongst Vitality members with diabetes. One presumed barrier to enrollment in the benefit amongst members with diabetes is a misperception of the particular relevance of the benefit and healthier food choices for their personal health. Improved messaging regarding the HealthyFood benefit and its particular salience for individuals with diabetes may be an effective means of increasing activation of the benefit in this population. The proposed study will be a collaboration between Discovery Health/Vitality and researchers at the Perelman School of Medicine at the University of Pennsylvania. In the proposed RCT, Vitality members with diabetes will be randomised to different types of messages regarding the HealthyFood benefit. The investigators will then compare the effectiveness of these different messaging strategies at increasing activation of the HealthyFood benefit amongst Vitality members with diabetes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults over age 18\n2. Vitality health members who have not yet enrolled in the Vitality HealthyFood benefit\n3. Diagnosis of type 2 diabetes (based on registration for chronic benefits for type 2 diabetes)\n4. Have registered on to Discovery Health/Vitality website in the past (marker of Internet access and availability of email address)\n\nExclusion Criteria:\n\n* Anyone who does not meet above criteria'}, 'identificationModule': {'nctId': 'NCT02462057', 'briefTitle': 'Testing Different Messaging Approaches to Increase Activation of a HealthyFood Benefit in Adults With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Testing the Effectiveness of Different Messaging Approaches to Increase Activation of a HealthyFood Benefit Amongst Individuals With Diabetes: A Randomised, Controlled Trial', 'orgStudyIdInfo': {'id': '821895'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'This arm will represent current practice. This group will receive no contact from the research team. They may receive information regarding the benefit from the Vitality marketing team during the intervention period and can enroll in the benefit at any time during the study period.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diabetes-specific', 'description': 'This group will receive a message which simply cites the two specific benefits of the eating more healthy foods for individuals with diabetes. This message contains a link to start the enrolment process.', 'interventionNames': ['Other: Email message regarding the HealthyFood benefit']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Experience of another member', 'description': 'This group will receive a message that includes a quote from the perspective of a Vitality member with diabetes who uses the HealthyFood benefit. Given the need to standardise message content across study arms, the quote was written by the study team and not an actual member. The quote emphasizes the positive impact the benefit has had for the member-both the financial benefit, as well as the two specific diabetes health benefits.', 'interventionNames': ['Other: Email message regarding the HealthyFood benefit']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Input from a diabetes expert', 'description': "This group will receive a message that includes a quote from a South African physician who specializes in diabetes. The quote emphasises the financial benefit and the two specific diabetes health benefits of the HealthyFood program included in the other messages. It concludes with the doctor's recommendation of the benefit for all individuals with diabetes.", 'interventionNames': ['Other: Email message regarding the HealthyFood benefit']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced active choice', 'description': "This group will receive a message whose first portion is identical to those in the diabetes-specific message group. The second portion of the message differs in that instead of just asking recipients to click on the provided link if interested, the message asks people to choose and click on one of following possible responses:\n\n1. Yes! I want to active the HealthyFood benefit and get up to 25% cash back on the healthy food I buy at Pick n Pay or Woolworths\n2. No, I'd prefer not to activate and continue paying full price for my healthy food purchases", 'interventionNames': ['Other: Email message regarding the HealthyFood benefit']}], 'interventions': [{'name': 'Email message regarding the HealthyFood benefit', 'type': 'OTHER', 'armGroupLabels': ['Diabetes-specific', 'Enhanced active choice', 'Experience of another member', 'Input from a diabetes expert']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Discovery Health', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'VA Advanced Fellow, Philadelphia VA Medical Center', 'investigatorFullName': 'Anjali Gopalan', 'investigatorAffiliation': 'University of Pennsylvania'}}}}