Dissemination of a Theory-Based Bone Health Program in Online

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963169
• Other study ID #: HP-00041186
• Secondary ID: R01NR011296
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: February 2013

Study information

• Verified date: November 2019
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 866
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Behaviors
• Osteoporosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Institute of Nursing Research (NINR)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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])	8 weeks
Primary	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.)	8 weeks
Primary	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.)	8 weeks