Dissemination of a Theory-Based Bone Health Program in Online

May 4, 2022 updated by: Eun-Shim Nahm, University of Maryland, Baltimore

Dissemination of a Theory-Based Bone Health Program in Online Communities

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Not necessary as the content is covered in other areas of this application.

Study Type

Interventional

Enrollment (Actual)

866

Phase

  • Not Applicable

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TO-BoneHealth Group
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.
Behavioral: TO-BoneHealth Program (Bone Power Program)
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.
Experimental: TO-BoneHealth Plus Group
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.
Behavioral: TO-BoneHealth Plus Program (Bone Power Plus Program)
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.
No Intervention: Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Osteoporosis Knowledge, Self-efficacy/Outcome Expectations for Calcium Intake and Exercise, Health Behaviors (Calcium Intake, Exercise)
Time Frame: 8 weeks

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])
8 weeks
Changes in Calcium Intake
Time Frame: 8 weeks
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.)
8 weeks
Changes in Exercise Time
Time Frame: 8 weeks
Exercise behavior was assessed using the 6-item exercise subscale that is part of the Yale Physical Activity Survey. (Higher value is better.)
8 weeks

Collaborators and Investigators

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

Sponsor

University of Maryland, Baltimore

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Eun-Shim Nahm, PhD, University of Maryland, Baltimore

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)

December 1, 2010

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

April 24, 2013

First Submitted That Met QC Criteria

October 12, 2013

First Posted (Estimate)

October 16, 2013

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00041186
  • R01NR011296 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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