NCT01740674

Brief Summary

One of the biggest challenges of conducting research where the investigators follow people over a long period of time is keeping the participants involved. One of way that investigators may be able to improve participant involvement in research is to give participants the opportunity to complete their questionnaires online. Here's how the investigators think the Internet data collection system will help to keep participants involved and ultimately help to answer important questions about the effects of nutrition during pregnancy:

  1. 1.It will allow investigators to present complicated questionnaires in a way that doesn't confuse participants. For example, instead of telling participants to skip the remainder of a question if they answered no to the first part of the question, the ePRO system does the skipping for them. The result is less confusion, fewer questions to read, and less of the participant's time.
  2. 2.It provides a convenient way for participants to keep track of where to find the questionnaire, and how much they have already completed. Participants sometimes don't have time to answer all of the investigator's questions in one sitting. The ePRO system keeps track of how much participants have already done and it's ready to keep going whenever the participant has time. It also avoids the common problem of losing the questionnaires to the household paperwork pile, or worse to the recycling bin.
  3. 3.It provides timely reminders to participants. Study participants, and especially new moms, are busy and they forget to complete the questionnaires. The ePRO system can provide timely reminders encouraging participants to respond.
  4. 4.It helps participants complete the questionnaires accurately. The ePRO system has an automatic error detection ability that will alert participants to any questions they missed or completed incorrectly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
301

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration 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

November 20, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

1.9 years

First QC Date

November 20, 2012

Last Update Submit

December 4, 2014

Conditions

Keywords

internet data collectionlongitudinal researchcohort retention

Outcome Measures

Primary Outcomes (2)

  • Participant retention 6 months postpartum

    participant retention is defined as the number of participants providing data at 6 months postpartum.

    postpartum 6 months

  • Participant retention 12 months postpartum

    participant retention is defined as the number of participants providing data at 12 months postpartum.

    12 months postpartum

Secondary Outcomes (2)

  • Completeness of collected data 6 months postpartum

    postpartum 6 months

  • Completeness of collected data 12 months postpartum

    postpartum 12 months

Study Arms (2)

Electronic data collection

EXPERIMENTAL

The group of participants who will complete questionnaires via the internet

Other: Electronic data collection

Paper data collection

NO INTERVENTION

The group of participants who will continue to complete paper based questionnaires, as has been the practice for this longitudinal study.

Interventions

Electronic data collection

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • current participant in the Alberta Pregnancy Outcomes and Nutrition Study
  • woman must have an infant less than 1 year of age

You may not qualify if:

  • women who have formally withdrawn from the Alberta Pregnancy Outcomes and Nutrition Study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Related Publications (5)

  • Davis LL, Broome ME, Cox RP. Maximizing retention in community-based clinical trials. J Nurs Scholarsh. 2002;34(1):47-53. doi: 10.1111/j.1547-5069.2002.00047.x.

    PMID: 11901967BACKGROUND
  • Vergnaud AC, Touvier M, Mejean C, Kesse-Guyot E, Pollet C, Malon A, Castetbon K, Hercberg S. Agreement between web-based and paper versions of a socio-demographic questionnaire in the NutriNet-Sante study. Int J Public Health. 2011 Aug;56(4):407-17. doi: 10.1007/s00038-011-0257-5. Epub 2011 May 3.

    PMID: 21538094BACKGROUND
  • Smith B, Smith TC, Gray GC, Ryan MA; Millennium Cohort Study Team. When epidemiology meets the Internet: Web-based surveys in the Millennium Cohort Study. Am J Epidemiol. 2007 Dec 1;166(11):1345-54. doi: 10.1093/aje/kwm212. Epub 2007 Aug 28.

    PMID: 17728269BACKGROUND
  • Welker JA. Implementation of electronic data capture systems: barriers and solutions. Contemp Clin Trials. 2007 May;28(3):329-36. doi: 10.1016/j.cct.2007.01.001. Epub 2007 Jan 11.

    PMID: 17287151BACKGROUND
  • Birnbaum MH. Human research and data collection via the internet. Annu Rev Psychol. 2004;55:803-32. doi: 10.1146/annurev.psych.55.090902.141601.

    PMID: 14744235BACKGROUND

Study Officials

  • Gerry Giesbrecht, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 20, 2012

First Posted

December 4, 2012

Study Start

December 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations