NCT01963169

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
866

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Typical duration for not_applicable

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

Study Start

First participant enrolled

December 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 16, 2013

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

December 2, 2019

Completed
Last Updated

May 6, 2022

Status Verified

November 1, 2019

Enrollment Period

2.2 years

First QC Date

April 24, 2013

Results QC Date

April 24, 2017

Last Update Submit

May 4, 2022

Conditions

Keywords

Bone HealthOnline interventionDisseminationTheory-based intervention

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (3)

TO-BoneHealth Group

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.

Behavioral: TO-BoneHealth Program (Bone Power Program)

TO-BoneHealth Plus Group

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.

Behavioral: TO-BoneHealth Plus Program (Bone Power Plus Program)

Control Group

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.

Interventions

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 Group

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.

TO-BoneHealth Plus Group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

OsteoporosisHealth Behavior

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Limitations and Caveats

Participants were recruited from two large online communities, and these individuals may have been more familiar with the technology than the general older adult population.

Results Point of Contact

Title
Eun-Shim Nahm
Organization
University of Maryland, Baltimore

Study Officials

  • Eun-Shim Nahm, PhD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

April 24, 2013

First Posted

October 16, 2013

Study Start

December 1, 2010

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

May 6, 2022

Results First Posted

December 2, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share