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Effects of Web-Based Health Information on Risk Behavior for Youth With Type 1 Diabetes in College

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer-Based Web-Based Health Information
Provider-Based Web-Based Health Information
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 1

Eligibility Criteria

17 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Peer-Based Delivery

Provider-Based Delivery

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2016
Last Updated
November 13, 2017
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02883829
Brief Title
Effects of Web-Based Health Information on Risk Behavior for Youth With Type 1 Diabetes in College
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
May 10, 2017 (Actual)
Study Completion Date
May 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer-Based Delivery
Arm Type
Experimental
Arm Description
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.
Arm Title
Provider-Based Delivery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Peer-Based Web-Based Health Information
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Provider-Based Web-Based Health Information
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in attitudes, beliefs, and intentions about alcohol
Description
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.
Time Frame
Two Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elissa R Weitzman, ScD
Organizational Affiliation
Boston Children's Hospital, Harvard Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lauren Wisk, PhD
Organizational Affiliation
Boston Children's Hospital, Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34591022
Citation
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.
Results Reference
derived
PubMed Identifier
31010315
Citation
Wisk 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.
Results Reference
derived

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Effects of Web-Based Health Information on Risk Behavior for Youth With Type 1 Diabetes in College

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