Overview

This trial is active, not recruiting.

Conditions osteoporosis, health behaviors
Treatments to-bonehealth program (bone power program), to-bonehealth plus program (bone power plus program)
Sponsor University of Maryland
Collaborator National Institute of Nursing Research (NINR)
Start date June 2011
End date February 2013
Trial size 866 participants
Trial identifier NCT01963169, HP-00041186, R01NR011296

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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.
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)
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.
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)
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.

Primary Outcomes

Measure
Changes in Osteoporosis Knowledge, Self-efficacy/Outcome expectations for calcium intake and exercise, Health behaviors (calcium intake, exercise), eHealth literacy
time frame: Baseline, 8 weeks, 6, 12, and 18 months

Secondary Outcomes

Measure
RE-AIM Dimensions: Reach (No. and proportion of persons), Implementation (Extent to which the intervention is implemented as intended), and Maintenance outcomes (wgt loss)
time frame: Baseline, 8 weeks, 6, 12, and 18 months

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

Official title Dissemination of a Theory-Based Bone Health Program in Online Communities
Principal investigator Eun-Shim Nahm, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by University of Maryland.