Diabetes Mellitus, Type 1NCT02883829
Effects of Web-Based Health Information on Risk Behavior for Youth With Type 1 Diabetes in College
A study testing Peer-Based Web-Based Health Information and Provider-Based Web-Based Health Information in people with Diabetes Mellitus, Type 1, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Adolescence and emerging adulthood are critical periods during which health outcomes may be imperiled for youth with Type 1 Diabetes (T1D). Due to the strong presence of alcohol use in the college environment, college students with T1D may be especially vulnerable to these risks. Read more about this study
- Who is it for?
- Ages 17 to 25 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Peer-Based Web-Based Health Information and Provider-Based Web-Based Health Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2017to 10 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants will be eligible to be included given: self-report of medical diagnosis of Type 1 diabetes, membership in a college diabetes network (CDN) chapter or TuDiabetes (the sampling frame), attendance/matriculation in college, ability to read and understand English (the language of the surveys and the educational vignettes), access to the Internet, ages 17-25 years. Participants must consent to participation in the study and consent to be re-contacted for the two-week follow up assessment, and provide a valid e-mail address for re-contact.
Who cannot join
- Participants who do not report a diagnosis of T1D, those who are unable to speak/read English at a middle school reading level, use a computer keyboard and/or complete a web-based questionnaire will be excluded. Patients who do not consent to the 2-week follow up or do not provide a valid e-mail address for re-contact will also be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Health Promotion in Transition: Effects of Web-Based Health Information on Disease Management and Risk Behavior for Youth With Type 1 Diabetes in College
Adolescence and emerging adulthood are critical periods during which health outcomes may be imperiled for youth with Type 1 Diabetes (T1D). Due to the strong presence of alcohol use in the college environment, college students with T1D may be especially vulnerable to these risks.
Our goal is to develop preliminary evidence in support of a scalable intervention targeting diabetes health management and alcohol use avoidance for college youth with T1D. For this project the investigators will engage at least 120 youth with T1D in college. The study sample will be drawn from two national, non-profit, peer support based groups: the College Diabetes Network (CDN) and the TuDiabetes Network.
Read more
The study aims to 1) develop and pilot and educational video intervention; 2) determine the acceptability and efficiency of various web platforms for engaging college students in completing a survey about their health and alcohol use and to; 3) compare effectiveness of delivery of a brief intervention delivered by a peer versus a provider. The investigators plan to engage 120 college youth with T1D in completing a survey about their health knowledge and alcohol use behaviors.
Baseline survey items will ask participants about knowledge, attitudes, and practices/plans for diabetes self-management and alcohol use in college. In response to survey items, participants will provide information on topics including general and disease-specific health information, as well as attitudes, behavior, beliefs, and knowledge related to alcohol use. Participants will also respond to questions relating to social support, mental health, and perseverance and commitment to long term goals.
Following the baseline survey, participants will be presented with a brief educational video about diabetes self-management and alcohol use risks. Participants will be randomized to receive one of two educational video interventions. One version will be framed and delivered from a peer-based source and the other from a provider, content will otherwise be identical. Participants will receive 2 follow-up surveys; one immediately following viewing the video and the second two weeks later. Both the immediate follow-up and the 2-week follow-up survey will test salience, recall, and effects on health knowledge, beliefs and behavioral intentions.
While the main purpose of the pilot is to ascertain preferences in the absence of preliminary data, our a priori hypothesis is that peer delivery will have greater impact for this population.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Peer-Based Web-Based Health Information, Provider-Based Web-Based Health Information
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-Based Web-Based Health InformationBehavioural
The intervention will be a brief vignette to present educational content about alcohol use risks for Type 1 Diabetes; framed and delivered from a peer-based source. The content for the intervention will be drawn on existing theories of behavior change, including the concepts of 'consciousness raising', 'self-reevaluation' and 'helping relationships'. The intervention will comprise of PowerPoint slides for final implementation as a narrated video that can be posted to a website for participant viewing.
Provider-Based Web-Based Health InformationBehavioural
The intervention will be a brief vignette to present educational content about alcohol use risks for Type 1 Diabetes; framed and delivered from a provider-based source. The content for the intervention will be drawn on existing theories of behavior change, including the concepts of 'consciousness raising', 'self-reevaluation' and 'helping relationships'. The intervention will comprise of PowerPoint slides for final implementation as a narrated video that can be posted to a website for participant viewing.
| Study group | Role | What they receive |
|---|---|---|
| Peer-Based Delivery | Experimental | The Peer-Based Delivery Arm will receive a brief health information intervention (delivered as video content) about diabetes self-management and alcohol use risks, measuring effects on health knowledge. For this arm, a peer will be the spokesperson delivering the intervention content. Receives: Behavioral: Peer-Based Web-Based Health Information |
| Provider-Based Delivery | Experimental | The Provider-Based Delivery Arm will receive a brief health information intervention (delivered as video content) about diabetes self-management and alcohol use risks, measuring effects on health knowledge. For this arm, a healthcare provider will be the spokesperson delivering the intervention content. Receives: Behavioral: Provider-Based Web-Based Health Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in attitudes, beliefs, and intentions about alcohol
The primary goal of the proposed project is to determine the effectiveness of diabetes-specific alcohol messaging as delivered by a peer versus a provider, for educating youth in college with Type 1 Diabetes. The ultimate goal is to affect alcohol use behavior, knowledge, attitudes and beliefs and intentions, all of which are proximal to alcohol use behavior. The investigators will assess changes in attitudes, knowledge, beliefs, and intentions about alcohol both immediately following intervention delivery with an immediate follow-up questionnaire, as well with a two-week follow-up questionnaire.
Measured: Two Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study start4 Apr 2017
- Primary completion10 May 2017
- Study completion10 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elissa R. Weitzman, Boston Children's Hospital
- Investigators
- Elissa R Weitzman, ScD, Principal investigator, Boston Children's Hospital, Harvard Medical SchoolLauren Wisk, PhD, Principal investigator, Boston Children's Hospital, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883829
- Sponsor's protocol ID
- IRB-P00023029
- Status last verified
- Nov 2017
- First submitted
- 25 Aug 2016
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wisk LE, Magane KM, Nelson EB, Tsevat RK, Levy S, Weitzman ER. Psychoeducational Messaging to Reduce Alcohol Use for College Students With Type 1 Diabetes: Internet-Delivered Pilot Trial. J Med Internet Res. 2021 Sep 30;23(9):e26418. doi: 10.2196/26418.
PubMed 34591022Wisk LE, Nelson EB, Magane KM, Weitzman ER. Clinical Trial Recruitment and Retention of College Students with Type 1 Diabetes via Social Media: An Implementation Case Study. J Diabetes Sci Technol. 2019 May;13(3):445-456. doi: 10.1177/1932296819839503. Epub 2019 Apr 22.
PubMed 31010315
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Promotion in Transition: Effects of Web-Based Health Information on Disease Management and Risk Behavior for Youth With Type 1 Diabetes in College
- ClinicalTrials.gov ID
- NCT02883829
- Acronym / sponsor ID
- IRB-P00023029
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 10 May 2017 (actual)
- Study completion
- 10 May 2017 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adolescence and emerging adulthood are critical periods during which health outcomes may be imperiled for youth with Type 1 Diabetes (T1D). Due to the strong presence of alcohol use in the college environment, college students with T1D may be especially vulnerable to these risks.
Our goal is to develop preliminary evidence in support of a scalable intervention targeting diabetes health management and alcohol use avoidance for college youth with T1D. For this project the investigators will engage at least 120 youth with T1D in college. The study sample will be drawn from two national, non-profit, peer support based groups: the College Diabetes Network (CDN) and the TuDiabetes Network.
The study aims to 1) develop and pilot and educational video intervention; 2) determine the acceptability and efficiency of various web platforms for engaging college students in completing a survey about their health and alcohol use and to; 3) compare effectiveness of delivery of a brief intervention delivered by a peer versus a provider. The investigators plan to engage 120 college youth with T1D in completing a survey about their health knowledge and alcohol use behaviors.
Baseline survey items will ask participants about knowledge, attitudes, and practices/plans for diabetes self-management and alcohol use in college. In response to survey items, participants will provide information on topics including general and disease-specific health information, as well as attitudes, behavior, beliefs, and knowledge related to alcohol use. Participants will also respond to questions relating to social support, mental health, and perseverance and commitment to long term goals.
Following the baseline survey, participants will be presented with a brief educational video about diabetes self-management and alcohol use risks. Participants will be randomized to receive one of two educational video interventions. One version will be framed and delivered from a peer-based source and the other from a provider, content will otherwise be identical. Participants will receive 2 follow-up surveys; one immediately following viewing the video and the second two weeks later. Both the immediate follow-up and the 2-week follow-up survey will test salience, recall, and effects on health knowledge, beliefs and behavioral intentions.
While the main purpose of the pilot is to ascertain preferences in the absence of preliminary data, our a priori hypothesis is that peer delivery will have greater impact for this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer-Based Delivery | Experimental | Behavioral: Peer-Based Web-Based Health InformationThe Peer-Based Delivery Arm will receive a brief health information intervention (delivered as video content) about diabetes self-management and alcohol use risks, measuring effects on health knowledge. For this arm, a peer will be the spokesperson delivering the intervention content. |
| Provider-Based Delivery | Experimental | Behavioral: Provider-Based Web-Based Health InformationThe Provider-Based Delivery Arm will receive a brief health information intervention (delivered as video content) about diabetes self-management and alcohol use risks, measuring effects on health knowledge. For this arm, a healthcare provider will be the spokesperson delivering the intervention content. |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Participants will be eligible to be included given: self-report of medical diagnosis of Type 1 diabetes, membership in a college diabetes network (CDN) chapter or TuDiabetes (the sampling frame), attendance/matriculation in college, ability to read and understand English (the language of the surveys and the educational vignettes), access to the Internet, ages 17-25 years. Participants must consent to participation in the study and consent to be re-contacted for the two-week follow up assessment, and provide a valid e-mail address for re-contact.
Key exclusion criteria (1 listed)
- Participants who do not report a diagnosis of T1D, those who are unable to speak/read English at a middle school reading level, use a computer keyboard and/or complete a web-based questionnaire will be excluded. Patients who do not consent to the 2-week follow up or do not provide a valid e-mail address for re-contact will also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer-Based Web-Based Health InformationThe intervention will be a brief vignette to present educational content about alcohol use risks for Type 1 Diabetes; framed and delivered from a peer-based source. The content for the intervention will be drawn on existing theories of behavior change, including the concepts of 'consciousness raising', 'self-reevaluation' and 'helping relationships'. The intervention will comprise of PowerPoint slides for final implementation as a narrated video that can be posted to a website for participant viewing. | Behavioural | Peer-Based Delivery |
| Provider-Based Web-Based Health InformationThe intervention will be a brief vignette to present educational content about alcohol use risks for Type 1 Diabetes; framed and delivered from a provider-based source. The content for the intervention will be drawn on existing theories of behavior change, including the concepts of 'consciousness raising', 'self-reevaluation' and 'helping relationships'. The intervention will comprise of PowerPoint slides for final implementation as a narrated video that can be posted to a website for participant viewing. | Behavioural | Provider-Based Delivery |
Primary outcome
Changes in attitudes, beliefs, and intentions about alcohol
Time frame: Two Weeks
The primary goal of the proposed project is to determine the effectiveness of diabetes-specific alcohol messaging as delivered by a peer versus a provider, for educating youth in college with Type 1 Diabetes. The ultimate goal is to affect alcohol use behavior, knowledge, attitudes and beliefs and intentions, all of which are proximal to alcohol use behavior. The investigators will assess changes in attitudes, knowledge, beliefs, and intentions about alcohol both immediately following intervention delivery with an immediate follow-up questionnaire, as well with a two-week follow-up questionnaire.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Derived from this study: PubMed 34591022Wisk LE, Magane KM, Nelson EB, Tsevat RK, Levy S, Weitzman ER. Psychoeducational Messaging to Reduce Alcohol Use for College Students With Type 1 Diabetes: Internet-Delivered Pilot Trial. J Med Internet Res. 2021 Sep 30;23(9):e26418. doi: 10.2196/26418.
- Derived from this study: PubMed 31010315Wisk LE, Nelson EB, Magane KM, Weitzman ER. Clinical Trial Recruitment and Retention of College Students with Type 1 Diabetes via Social Media: An Implementation Case Study. J Diabetes Sci Technol. 2019 May;13(3):445-456. doi: 10.1177/1932296819839503. Epub 2019 Apr 22.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elissa R Weitzman, ScD principal investigator
Boston Children's Hospital, Harvard Medical School
Lauren Wisk, PhD principal investigator
Boston Children's Hospital, Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-Based Web-Based Health Information and Provider-Based Web-Based Health Information in people with Diabetes Mellitus, Type 1, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in attitudes, beliefs, and intentions about alcohol (time frame: Two Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02883829, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.