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Dissemination of a Theory-Based Bone Health Program in Online

Primary Purpose

Osteoporosis, Health Behaviors

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TO-BoneHealth Program (Bone Power Program)
TO-BoneHealth Plus Program (Bone Power Plus Program)
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring Bone Health, Online intervention, Dissemination, Theory-based intervention

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • being age 50 or older
  • having access to the Internet and e-mail (at home or other places such as public
  • libraries, computer lab, etc)
  • being able to use the Internet/e-mail independently
  • having an e-mail account (or being willing to obtain an e-mail account for this study)
  • currently residing in a community setting in the United States
  • being able to read and write English

Exclusion Criteria:

  • are currently participating in any study(s) on: falls, osteoporosis, and /or nutrition
  • had participated in our web-based hip fracture prevention conducted in 2006 - 2007

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    TO-BoneHealth Group

    TO-BoneHealth Plus Group

    Control Group

    Arm Description

    The group will use the 8-week TO-BoneHealth program, which includes: (1) web learning modules, (2) moderated discussion boards, (3) an Ask-the-Experts section, and (4) a virtual library. In addition, a tool kit and video lecture library are also available to participants. The program will be closed after 8 weeks, and there will be no eNewsletter or bi-weekly follow-ups of bone health behavior goal attainment. After 8 weeks, participants will receive a monthly e-mail informing them of the upcoming surveys.

    The group will use the TO-BoneHealth Plus program intervention, which includes the 8-week TO-BoneHealth program followed by bi-weekly theory-based eNewsletters with follow-up of each individual's maintenance of bone health behaviors for 10 months.

    No specific intervention will be provided to the control group participants. To keep in contact with participants, a monthly e-mail will be sent to inform them of upcoming follow-up surveys. At the end of the study (upon completion of all five surveys), the control group participants will receive a CD version of the TO-BoneHealth program via mail.

    Outcomes

    Primary Outcome Measures

    Changes in Osteoporosis Knowledge, Self-efficacy/Outcome Expectations for Calcium Intake and Exercise, Health Behaviors (Calcium Intake, Exercise)
    The 16-item knowledge on osteoporosis was measured using the revised Osteoporosis Knowledge Test (Range: 0 - 23 [higher better]) The 11-item self-efficacy for calcium intake subscale of the Osteoporosis Health Belief Scale. (Range: 11 - 110 [higher better]) The 9-item self-efficacy for Exercise scale. (Range: 0 - 90 [higher better]) The 6-item calcium intake outcome expectation subscale of the Osteoporosis Health Belief Scale (Range: 6 -30[higher better]) The 9-item outcome expectations for Exercise Scale. (scoring: range: 9 - 45 [higher better])
    Changes in Calcium Intake
    Dietary calcium intake was estimated using a short screening tool developed by Blalock et al. 4. It includes 22 items that assess both frequency and portions various foods that contain calcium and vitamin D. (Higher values are better.)
    Changes in Exercise Time
    Exercise behavior was assessed using the 6-item exercise subscale that is part of the Yale Physical Activity Survey. (Higher value is better.)

    Secondary Outcome Measures

    Full Information

    First Posted
    April 24, 2013
    Last Updated
    May 4, 2022
    Sponsor
    University of Maryland, Baltimore
    Collaborators
    National Institute of Nursing Research (NINR)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01963169
    Brief Title
    Dissemination of a Theory-Based Bone Health Program in Online
    Official Title
    Dissemination of a Theory-Based Bone Health Program in Online Communities
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2010 (Actual)
    Primary Completion Date
    February 2013 (Actual)
    Study Completion Date
    February 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Maryland, Baltimore
    Collaborators
    National Institute of Nursing Research (NINR)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Bone health is a significant public health issue in the United States. An estimated 10 million Americans age 50 and older are living with osteoporosis, and approximately 50% of women and 25% of men over age 50 will experience an osteoporosis-related fracture in their remaining lifetime. Recent research advancements have produced effective measures to improve and maintain bone health, including exercise, diet, screening tests, pharmacotherapies, and fall prevention strategies. These findings, however, have not been fully incorporated into the daily lives of adults, and many are unaware of the magnitude of bone-health problems. Thus, greater efforts must be made to effectively disseminate evidence-based research findings to improve bone health behaviors of the public. The Internet, with its increasing popularity, can be an effective tool in this endeavor. Despite a great deal of available online health resources, there has been a lack of research investigating effective methods to package and deliver these resources to yield positive public health outcomes. Expanding upon our prior findings and using an innovative approach combining two models of the social cognitive theory (SCT) and the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance), in this proposal, we propose a large scale online study (N = 866) that will compare the long-term impact of two SCT-based online bone health interventions in adults age 50 and older targeting two large online communities. The two interventions are (1) an 8-week SCT-based Online Bone Health (TO-BoneHealth) program and (2) a 12-month TO-BoneHealth Plus program, including the TO-BoneHealth program followed by biweekly theory-based eNewsletters with follow-up of each individual's bone health behaviors ("booster" intervention) for 10 months. The interventions' impact will be assessed on the following the modified RE-AIM framework: (a) Effectiveness (knowledge, selected bone health behaviors, fall incidence, initiation of a discussion about bone health with a primary care provider, eHealth literacy); (b) Reach (number of participants the program reached); (c) Implementation (program usage); and (d) Maintenance (participants' bone health behavior maintenance). With the rapid growth of online communities, findings from this study will significantly contribute to current eHealth practice and research and serve as a dissemination model for other health promotion projects targeting online communities.
    Detailed Description
    Not necessary as the content is covered in other areas of this application.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis, Health Behaviors
    Keywords
    Bone Health, Online intervention, Dissemination, Theory-based intervention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    866 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TO-BoneHealth Group
    Arm Type
    Experimental
    Arm Description
    The group will use the 8-week TO-BoneHealth program, which includes: (1) web learning modules, (2) moderated discussion boards, (3) an Ask-the-Experts section, and (4) a virtual library. In addition, a tool kit and video lecture library are also available to participants. The program will be closed after 8 weeks, and there will be no eNewsletter or bi-weekly follow-ups of bone health behavior goal attainment. After 8 weeks, participants will receive a monthly e-mail informing them of the upcoming surveys.
    Arm Title
    TO-BoneHealth Plus Group
    Arm Type
    Experimental
    Arm Description
    The group will use the TO-BoneHealth Plus program intervention, which includes the 8-week TO-BoneHealth program followed by bi-weekly theory-based eNewsletters with follow-up of each individual's maintenance of bone health behaviors for 10 months.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    No specific intervention will be provided to the control group participants. To keep in contact with participants, a monthly e-mail will be sent to inform them of upcoming follow-up surveys. At the end of the study (upon completion of all five surveys), the control group participants will receive a CD version of the TO-BoneHealth program via mail.
    Intervention Type
    Behavioral
    Intervention Name(s)
    TO-BoneHealth Program (Bone Power Program)
    Intervention Description
    The 8-week TO-BoneHealth program include: (1) web learning modules, (2) moderated discussion boards, (3) an Ask-the-Experts section, and (4) a virtual library. In addition, a tool kit and video lecture library are also available to participants. The program will be closed after 8 weeks, and there will be no eNewsletter or bi-weekly follow-ups of bone health behavior goal attainment. After 8 weeks, participants will receive a monthly e-mail informing them of the upcoming surveys.
    Intervention Type
    Behavioral
    Intervention Name(s)
    TO-BoneHealth Plus Program (Bone Power Plus Program)
    Intervention Description
    This intervention includes the 8-week TO-BoneHealth program followed by bi-weekly theory-based eNewsletters with follow-up of each individual's maintenance of bone health behaviors for 10 months.
    Primary Outcome Measure Information:
    Title
    Changes in Osteoporosis Knowledge, Self-efficacy/Outcome Expectations for Calcium Intake and Exercise, Health Behaviors (Calcium Intake, Exercise)
    Description
    The 16-item knowledge on osteoporosis was measured using the revised Osteoporosis Knowledge Test (Range: 0 - 23 [higher better]) The 11-item self-efficacy for calcium intake subscale of the Osteoporosis Health Belief Scale. (Range: 11 - 110 [higher better]) The 9-item self-efficacy for Exercise scale. (Range: 0 - 90 [higher better]) The 6-item calcium intake outcome expectation subscale of the Osteoporosis Health Belief Scale (Range: 6 -30[higher better]) The 9-item outcome expectations for Exercise Scale. (scoring: range: 9 - 45 [higher better])
    Time Frame
    8 weeks
    Title
    Changes in Calcium Intake
    Description
    Dietary calcium intake was estimated using a short screening tool developed by Blalock et al. 4. It includes 22 items that assess both frequency and portions various foods that contain calcium and vitamin D. (Higher values are better.)
    Time Frame
    8 weeks
    Title
    Changes in Exercise Time
    Description
    Exercise behavior was assessed using the 6-item exercise subscale that is part of the Yale Physical Activity Survey. (Higher value is better.)
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: being age 50 or older having access to the Internet and e-mail (at home or other places such as public libraries, computer lab, etc) being able to use the Internet/e-mail independently having an e-mail account (or being willing to obtain an e-mail account for this study) currently residing in a community setting in the United States being able to read and write English Exclusion Criteria: are currently participating in any study(s) on: falls, osteoporosis, and /or nutrition had participated in our web-based hip fracture prevention conducted in 2006 - 2007
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eun-Shim Nahm, PhD
    Organizational Affiliation
    University of Maryland, Baltimore
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26675352
    Citation
    Nahm ES, Resnick B, Brown C, Zhu S, Magaziner J, Bellantoni M, Brennan PF, Charters K, Brown J, Rietschel M, An M, Park BK. The Effects of an Online Theory-Based Bone Health Program for Older Adults. J Appl Gerontol. 2017 Sep;36(9):1117-1144. doi: 10.1177/0733464815617284. Epub 2015 Dec 16.
    Results Reference
    derived

    Learn more about this trial

    Dissemination of a Theory-Based Bone Health Program in Online

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