Trial Outcomes & Findings for Dissemination of a Theory-Based Bone Health Program in Online (NCT NCT01963169)
NCT ID: NCT01963169
Last Updated: 2022-05-06
Results Overview
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 \[higher better\])
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
866 participants
Primary outcome timeframe
8 weeks
Results posted on
2022-05-06
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
301
|
302
|
263
|
|
Overall Study
COMPLETED
|
242
|
220
|
237
|
|
Overall Study
NOT COMPLETED
|
59
|
82
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dissemination of a Theory-Based Bone Health Program in Online
Baseline characteristics by cohort
| Measure |
TO-BoneHealth Group
n=301 Participants
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 Plus Group
n=302 Participants
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.
|
Control Group
n=263 Participants
No specific intervention will be provided to the control group participants.
|
Total
n=866 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
213 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
578 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
88 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
288 Participants
n=4 Participants
|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
63 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
63.5 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
317 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
183 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
549 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
301 Participants
n=5 Participants
|
302 Participants
n=7 Participants
|
263 Participants
n=5 Participants
|
866 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who completed the 8-week survey.
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 \[higher better\])
Outcome measures
| Measure |
TO-BoneHealth Group
n=234 Participants
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.
|
TO-BoneHealth Plus Group
n=226 Participants
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.
|
Control Group
n=245 Participants
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.
|
|---|---|---|---|
|
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
|
19.3 units on a scale
Standard Deviation 4.1
|
16.7 units on a scale
Standard Deviation 4.4
|
|
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
|
90.8 units on a scale
Standard Deviation 16.1
|
82.7 units on a scale
Standard Deviation 21.2
|
|
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
|
22.9 units on a scale
Standard Deviation 4.0
|
22.5 units on a scale
Standard Deviation 3.7
|
|
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
|
50.8 units on a scale
Standard Deviation 25.0
|
47.5 units on a scale
Standard Deviation 26.4
|
|
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
|
37.2 units on a scale
Standard Deviation 7.0
|
36.6 units on a scale
Standard Deviation 7.6
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who completed the 8-week survey.
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.)
Outcome measures
| Measure |
TO-BoneHealth Group
n=234 Participants
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.
|
TO-BoneHealth Plus Group
n=226 Participants
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.
|
Control Group
n=245 Participants
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.
|
|---|---|---|---|
|
Changes in Calcium Intake
|
1538.4 mg
Standard Deviation 1289.2
|
1513.3 mg
Standard Deviation 1367.6
|
1278.1 mg
Standard Deviation 1059.6
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who completed the 8-week survey.
Exercise behavior was assessed using the 6-item exercise subscale that is part of the Yale Physical Activity Survey. (Higher value is better.)
Outcome measures
| Measure |
TO-BoneHealth Group
n=234 Participants
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.
|
TO-BoneHealth Plus Group
n=226 Participants
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.
|
Control Group
n=245 Participants
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.
|
|---|---|---|---|
|
Changes in Exercise Time
|
160.6 minutes
Standard Deviation 196.0
|
137.1 minutes
Standard Deviation 203.8
|
125.6 minutes
Standard Deviation 177.9
|
Adverse Events
TO-BoneHealth Group
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
TO-BoneHealth Plus Group
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TO-BoneHealth Group
n=301 participants at risk
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.
|
TO-BoneHealth Plus Group
n=302 participants at risk
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.
|
Control Group
n=263 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Not associated/unlikely to be associated to the investigational product/procedure, Unexpected
|
4.7%
14/301 • Number of events 14 • 12 months (throughout the data collection period)
Other Adverse Events: Specific adverse event terms are not collected (Reported as "Not associated/unlikely to be associated to the investigational product/procedure, Unexpected")
|
8.3%
25/302 • Number of events 25 • 12 months (throughout the data collection period)
Other Adverse Events: Specific adverse event terms are not collected (Reported as "Not associated/unlikely to be associated to the investigational product/procedure, Unexpected")
|
2.7%
7/263 • Number of events 7 • 12 months (throughout the data collection period)
Other Adverse Events: Specific adverse event terms are not collected (Reported as "Not associated/unlikely to be associated to the investigational product/procedure, Unexpected")
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place