Health Behaviors, Osteoporosis
Conditions
Keywords
Bone Health, Online intervention, Dissemination, Theory-based intervention
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.
Interventions
BEHAVIORALTO-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.
BEHAVIORALTO-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.
Sponsors
National Institute of Nursing Research (NINR)
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Osteoporosis Knowledge, Self-efficacy/Outcome Expectations for Calcium Intake and Exercise, Health Behaviors (Calcium Intake, Exercise) | 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 \[higher better\]) |
| Changes in Calcium Intake | 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.) |
| Changes in Exercise Time | 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.) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 301 |
| TO-BoneHealth Plus Group 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. | 302 |
| Control Group No specific intervention will be provided to the control group participants. | 263 |
| Total | 866 |
Baseline characteristics
| Characteristic | TO-BoneHealth Plus Group | Control Group | TO-BoneHealth Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 105 Participants | 95 Participants | 88 Participants | 288 Participants |
| Age, Categorical Between 18 and 65 years | 197 Participants | 168 Participants | 213 Participants | 578 Participants |
| Age, Continuous | 63 years STANDARD_DEVIATION 8.5 | 63.5 years STANDARD_DEVIATION 8.5 | 62.1 years STANDARD_DEVIATION 8.5 | 62.8 years STANDARD_DEVIATION 8.5 |
| Region of Enrollment United States | 302 Participants | 263 Participants | 301 Participants | 866 Participants |
| Sex: Female, Male Female | 108 Participants | 91 Participants | 118 Participants | 317 Participants |
| Sex: Female, Male Male | 194 Participants | 172 Participants | 183 Participants | 549 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 301 | 0 / 302 | 0 / 263 |
| other Total, other adverse events | 14 / 301 | 25 / 302 | 7 / 263 |
| serious Total, serious adverse events | 0 / 301 | 0 / 302 | 0 / 263 |
Outcome results
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.)
Time frame: 8 weeks
Population: Participants who completed the 8-week survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TO-BoneHealth Group | Changes in Calcium Intake | 1538.4 mg | Standard Deviation 1289.2 |
| TO-BoneHealth Plus Group | Changes in Calcium Intake | 1513.3 mg | Standard Deviation 1367.6 |
| Control Group | Changes in Calcium Intake | 1278.1 mg | Standard Deviation 1059.6 |
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.)
Time frame: 8 weeks
Population: Participants who completed the 8-week survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TO-BoneHealth Group | Changes in Exercise Time | 160.6 minutes | Standard Deviation 196 |
| TO-BoneHealth Plus Group | Changes in Exercise Time | 137.1 minutes | Standard Deviation 203.8 |
| Control Group | Changes in Exercise Time | 125.6 minutes | Standard Deviation 177.9 |
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 \[higher better\])
Time frame: 8 weeks
Population: Participants who completed the 8-week survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TO-BoneHealth Group | Changes in Osteoporosis Knowledge, Self-efficacy/Outcome Expectations for Calcium Intake and Exercise, Health Behaviors (Calcium Intake, Exercise) | Exercise Self-Efficacy | 51.3 units on a scale | Standard Deviation 26.4 |
| TO-BoneHealth Group | Changes in Osteoporosis Knowledge, Self-efficacy/Outcome Expectations for Calcium Intake and Exercise, Health Behaviors (Calcium Intake, Exercise) | CA Intake Outcome Expectations | 23.3 units on a scale | Standard Deviation 3.6 |
| TO-BoneHealth Group | Changes in Osteoporosis Knowledge, Self-efficacy/Outcome Expectations for Calcium Intake and Exercise, Health Behaviors (Calcium Intake, Exercise) | Osteoporosis Knowledge | 19.8 units on a scale | Standard Deviation 3.8 |
| TO-BoneHealth Group | Changes in Osteoporosis Knowledge, Self-efficacy/Outcome Expectations for Calcium Intake and Exercise, Health Behaviors (Calcium Intake, Exercise) | CA Intake Self-Efficacy | 89.9 units on a scale | Standard Deviation 17.8 |
| TO-BoneHealth Group | Changes in Osteoporosis Knowledge, Self-efficacy/Outcome Expectations for Calcium Intake and Exercise, Health Behaviors (Calcium Intake, Exercise) | Exercise Outcome Expectations | 37.8 units on a scale | Standard Deviation 7.1 |
| TO-BoneHealth Plus Group | Changes in Osteoporosis Knowledge, Self-efficacy/Outcome Expectations for Calcium Intake and Exercise, Health Behaviors (Calcium Intake, Exercise) | CA Intake Outcome Expectations | 22.9 units on a scale | Standard Deviation 4 |
| TO-BoneHealth Plus Group | Changes in Osteoporosis Knowledge, Self-efficacy/Outcome Expectations for Calcium Intake and Exercise, Health Behaviors (Calcium Intake, Exercise) | Osteoporosis Knowledge | 19.3 units on a scale | Standard Deviation 4.1 |
| TO-BoneHealth Plus Group | Changes in Osteoporosis Knowledge, Self-efficacy/Outcome Expectations for Calcium Intake and Exercise, Health Behaviors (Calcium Intake, Exercise) | CA Intake Self-Efficacy | 90.8 units on a scale | Standard Deviation 16.1 |
| TO-BoneHealth Plus Group | Changes in Osteoporosis Knowledge, Self-efficacy/Outcome Expectations for Calcium Intake and Exercise, Health Behaviors (Calcium Intake, Exercise) | Exercise Self-Efficacy | 50.8 units on a scale | Standard Deviation 25 |
| TO-BoneHealth Plus Group | Changes in Osteoporosis Knowledge, Self-efficacy/Outcome Expectations for Calcium Intake and Exercise, Health Behaviors (Calcium Intake, Exercise) | Exercise Outcome Expectations | 37.2 units on a scale | Standard Deviation 7 |
| Control Group | Changes in Osteoporosis Knowledge, Self-efficacy/Outcome Expectations for Calcium Intake and Exercise, Health Behaviors (Calcium Intake, Exercise) | Exercise Outcome Expectations | 36.6 units on a scale | Standard Deviation 7.6 |
| Control Group | Changes in Osteoporosis Knowledge, Self-efficacy/Outcome Expectations for Calcium Intake and Exercise, Health Behaviors (Calcium Intake, Exercise) | Exercise Self-Efficacy | 47.5 units on a scale | Standard Deviation 26.4 |
| Control Group | Changes in Osteoporosis Knowledge, Self-efficacy/Outcome Expectations for Calcium Intake and Exercise, Health Behaviors (Calcium Intake, Exercise) | Osteoporosis Knowledge | 16.7 units on a scale | Standard Deviation 4.4 |
| Control Group | Changes in Osteoporosis Knowledge, Self-efficacy/Outcome Expectations for Calcium Intake and Exercise, Health Behaviors (Calcium Intake, Exercise) | CA Intake Outcome Expectations | 22.5 units on a scale | Standard Deviation 3.7 |
| Control Group | Changes in Osteoporosis Knowledge, Self-efficacy/Outcome Expectations for Calcium Intake and Exercise, Health Behaviors (Calcium Intake, Exercise) | CA Intake Self-Efficacy | 82.7 units on a scale | Standard Deviation 21.2 |
Comparison: At 8 week, both intervention groups received the same Bone Power Program intervention. Thus, the analysis for the 8-week outcomes was completed as a two-armed RCT.p-value: <0.001Mixed Models Analysis
Comparison: At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.p-value: <0.001Mixed Models Analysis
Comparison: At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.p-value: 0.009Mixed Models Analysis
Comparison: At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.p-value: 0.002Mixed Models Analysis
Comparison: At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.p-value: 0.032Mixed Models Analysis