NCT02883829

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

April 4, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

1 month

First QC Date

August 25, 2016

Last Update Submit

November 13, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Two Weeks

Study Arms (2)

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.

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.

Behavioral: Provider-Based Web-Based Health Information

Interventions

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.

Peer-Based Delivery

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.

Provider-Based Delivery

Eligibility Criteria

Age17 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Elissa R Weitzman, ScD

    Boston Children's Hospital, Harvard Medical School

    PRINCIPAL INVESTIGATOR
  • Lauren Wisk, PhD

    Boston Children's Hospital, Harvard Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Scientist

Study Record Dates

First Submitted

August 25, 2016

First Posted

August 30, 2016

Study Start

April 4, 2017

Primary Completion

May 10, 2017

Study Completion

May 10, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations