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

November 13, 2017 updated by: Elissa R. Weitzman, Boston Children's Hospital

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peer-Based Delivery
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.
Behavioral: Peer-Based Web-Based Health Information
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.
Experimental: Provider-Based Delivery
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.
Behavioral: Provider-Based Web-Based Health Information
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Elissa R Weitzman, ScD, Boston Children's Hospital, Harvard Medical School
  • Principal Investigator: Lauren Wisk, PhD, Boston Children's Hospital, Harvard Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2017

Primary Completion (Actual)

May 10, 2017

Study Completion (Actual)

May 10, 2017

Study Registration Dates

First Submitted

August 25, 2016

First Submitted That Met QC Criteria

August 25, 2016

First Posted (Estimate)

August 30, 2016

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 13, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-P00023029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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