OsteoporosisS2BSNCT03405103
Striving to be Strong: Self-management
A study testing Striving, Boning-Up and Personal Choice in people with Osteoporosis and Health Behavior, run by University of Wisconsin, Milwaukee.
Trial summary
The vast majority of people want to be healthy and often make a change to be healthier. Change that is begun is seldom maintained. Osteoporosis is an example of one condition where people are encouraged to regularly engage in preventative health behaviors. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Health Behavior
- What is being tested?
- Striving, Boning-Up and Personal Choice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2012to 30 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy (able to participate in physical activity, not receiving medical care for chronic condition, not taking medications that would affect bone, greater than 5 years post treatment for cancer) not pregnant or lactating speaks and reads English consumes at least 200 mg less recommended amount of dietary calcium
Who cannot join
- diagnosis of osteoporosis, history of fragile fracture, does not engage in vigorous activity more than 2 times a week
About this study
Official title: Efficacy of m-Health Self-Management Intervention
The vast majority of people want to be healthy and often make a change to be healthier. Change that is begun is seldom maintained. Osteoporosis is an example of one condition where people are encouraged to regularly engage in preventative health behaviors. This is a study testing a new approach to helping women engage in osteoporosis health behaviors. This new approach includes beliefs, self-regulating skills and abilities, and social facilitation delivered via a cell phone app. If effective, this approach could be tested with other health behaviors.
Read the detailed description
The goal of this project is to test the efficacy a theory based, patient-centered, dynamically tailored intervention delivered via a cell phone app. The four aims of this project are to: 1) Test the efficacy of the intervention to improve long term maintenance of osteoporosis prevention health behaviors in midlife women, 2) evaluate moderators and mediators of long-term engagement in health behaviors, 3) describe processes of health behavior change and evaluate differences within and between subjects using Ecological Momentary Assessments (EMA) as a complement to traditional measures and 4) evaluate the utility of The Individual and Family Self-Management Theory to explain health behavior change. In the U.S., over 35 million women either have or are at high risk for osteoporosis at an anticipated cost of greater than $25 billion by 2025. Osteoporosis affects 1 out of 2 White women, is rapidly growing among populations of color and causes high chronic disease burden worldwide. Less than 6% of women regularly engage in the basic health promotion behaviors. The vast disparity between the high prevalence of osteoporosis and the low number of people who engage in preventative care highlights this condition as one of many striking examples of the crucial role behavior change could play in improving health and decreasing health care costs. New knowledge suggests enhancing knowledge and beliefs, self-regulation skill and abilities, and social facilitation leads to self-management and improved health outcomes. It is hypothesized that the more an intervention integrates health behavior change processes into daily activities the more likely it is to increases one's capacity to self-manage. The work proposed is significant because it focuses on the serious and prevalent condition of osteoporosis; tests the application of a theory based, patient-centered, dynamic intervention designed to improve outcomes; and, decisively bundles new knowledge about methodologies, intervention processes, and delivery media to provide a cohesive foundation for intervention development and testing. Innovative aspects include use of EMAs as a complementary approach to providing feedback and measuring behavior change processes; testing a newly identified health behavior change theory; and development and evaluation of a cell phone app, one type of m-Health. Through technological advances we now have the capacity to integrate health behavior change processes into every day activities via a cell phone app but the effectiveness of the app to change health behaviors has not been demonstrated empirically. A three-group randomized controlled longitudinal design with data collected at baseline, 3, 6, 9, and 12 months will be used. A convenience sample of 288 (96 per group) community dwelling women will be enrolled. Outcomes will be evaluated with self-report, behavioral performance, and bio-behavioral measures, including DXA and vitamin D. The expected outcomes are achievement of an increase in women's initiation and long term maintenance of osteoporosis self-management behaviors and stabilization of bone mineral density.
- Conditions
- Osteoporosis, Health Behavior
- Being tested
- Striving, Boning-Up, Personal Choice
- Keywords
- self-management, m-Health
- Medical subject headings
- Osteoporosis, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrivingBehavioural
Also called S2BS
Boning-UpBehavioural
Personal ChoiceBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Striving | Experimental | Striving vs Boning-up \& Personal Choice Receives: Behavioral: Striving |
| Boning-up Standard Education | Active comparator | Boning-up vs Striving and Personal Choice Receives: Behavioral: Boning-Up |
| Personal Choice | Sham comparator | Personal Choice vs Striving \& Boning-up Receives: Behavioral: Personal Choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bone Mineral Density
Bone Mineral Density obtained via Dual Energy x-ray absorptiometry
Measured: Baseline and 12 months
Secondary outcomes (8)
Calcium Focused Food Diary
mg of calcium obtained via food as measured by Calcium Focused Food Diary. Calculated daily for 3-days. Total mg of calcium across 3 measurement days used .
Measured: Baseline, 3, 6, 9, and 12 months
Physical Activity Questionnaire (IPAQ)- Short Form: Measure of time and intensity of persons engagement in physical activity.
Self-report of frequency and intensity of engagement in common leisure time (non-work related) Physical Activites. Calculated score accounts for time and METs. Data are collected over a 7-day period of time across pre-specified categories of leisure time activities and total score calculated by adding totals obtained for each day. Sub-totals of low, medium, and vigorous activities. Higher the score is associated with higher level of activities.
Measured: Baseline, 3, 6, 9, and 12 months
Balance
4 stage Balance Test: Ability to hold one of four positions for 45 seconds. Positions inclue eyes open, both feet on ground: eyes closed both feet on ground: eyes open, one foot on ground; eyes closed, one foot on ground. Scored by adding total seconds across 4 positions.
Measured: Baseline and 12 months
Stand Test
Leg strength: time it takes participant to stand and sit ten times, Measured in seconds.
Measured: Baseline and 12 months
6-minute walk test
Functional Status: measure of distance walked in 6 minutes. Measured in feet and inches
Measured: Baseline and 12 months
Functional Movement Screen (adaptation)
Strength and Balance. Test includes four movements specifically hurdle step, in-line lunge, straight leg raise, and squat. All movements were video taped from two positions (front and side). Certified professionals evaluated the videoed four movement and scored each movement using a standardized scoring template. Individual scores are obtained for each of the four movement and a total score is obtained by adding the scores from the four movements. Scores for each movement include 0=pain and score of 1-3 with 3 indicating the best performance.
Measured: Baseline and 12 months
Engagement in Self-regulation processes: "What are you doing today"/ DOTs
Ecological Momentary Assessments. Osteoporosis prevention focuses on four behaviors: calcium intake, balance, core and leg strength, and physical activity. For each of the four behaviors the participant indicates (using a yes or no response) if they engaged in any of the self-regulation processes (e.g., setting a goal, making a plan, engaging in the behavior, monitoring) for each of the 4 behaviors (calcium, balance, strength, and physical activity.
For each of these four behaviors participants select all of the component of the Self-regulation process
Measured: Over 12 months a total of 284 text message were sent to each participant via newly designed app. Score included frequency of behavior and self-regulation process for 4 week periods over 12 months.
vitamin D
serum vitamin D level measured in nmole/L
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start1 Oct 2012
- Primary completion15 May 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Repeated measures randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Collaborators
- Marquette University, Medical College of Wisconsin
- Responsible party
- Principal investigator, Polly Ryan, PhD, RN, FAAN, University of Wisconsin, Milwaukee
- Investigators
- Polly A Ryan, PhD, Principal investigator, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405103
- Sponsor's protocol ID
- R01NR013913-01
- Acronym
- S2BS
- Status last verified
- Jan 2018
- First submitted
- 6 Jan 2018
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of m-Health Self-Management Intervention
- ClinicalTrials.gov ID
- NCT03405103
- Acronym / sponsor ID
- S2BS / R01NR013913-01
- Conditions
- Osteoporosis, Health Behavior
- Keywords
- self-management, m-Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Collaborators
- Marquette University, Medical College of Wisconsin
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 15 May 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The vast majority of people want to be healthy and often make a change to be healthier. Change that is begun is seldom maintained. Osteoporosis is an example of one condition where people are encouraged to regularly engage in preventative health behaviors. This is a study testing a new approach to helping women engage in osteoporosis health behaviors. This new approach includes beliefs, self-regulating skills and abilities, and social facilitation delivered via a cell phone app. If effective, this approach could be tested with other health behaviors.
Detailed description
The goal of this project is to test the efficacy a theory based, patient-centered, dynamically tailored intervention delivered via a cell phone app. The four aims of this project are to: 1) Test the efficacy of the intervention to improve long term maintenance of osteoporosis prevention health behaviors in midlife women, 2) evaluate moderators and mediators of long-term engagement in health behaviors, 3) describe processes of health behavior change and evaluate differences within and between subjects using Ecological Momentary Assessments (EMA) as a complement to traditional measures and 4) evaluate the utility of The Individual and Family Self-Management Theory to explain health behavior change. In the U.S., over 35 million women either have or are at high risk for osteoporosis at an anticipated cost of greater than $25 billion by 2025. Osteoporosis affects 1 out of 2 White women, is rapidly growing among populations of color and causes high chronic disease burden worldwide. Less than 6% of women regularly engage in the basic health promotion behaviors. The vast disparity between the high prevalence of osteoporosis and the low number of people who engage in preventative care highlights this condition as one of many striking examples of the crucial role behavior change could play in improving health and decreasing health care costs. New knowledge suggests enhancing knowledge and beliefs, self-regulation skill and abilities, and social facilitation leads to self-management and improved health outcomes. It is hypothesized that the more an intervention integrates health behavior change processes into daily activities the more likely it is to increases one's capacity to self-manage. The work proposed is significant because it focuses on the serious and prevalent condition of osteoporosis; tests the application of a theory based, patient-centered, dynamic intervention designed to improve outcomes; and, decisively bundles new knowledge about methodologies, intervention processes, and delivery media to provide a cohesive foundation for intervention development and testing. Innovative aspects include use of EMAs as a complementary approach to providing feedback and measuring behavior change processes; testing a newly identified health behavior change theory; and development and evaluation of a cell phone app, one type of m-Health. Through technological advances we now have the capacity to integrate health behavior change processes into every day activities via a cell phone app but the effectiveness of the app to change health behaviors has not been demonstrated empirically. A three-group randomized controlled longitudinal design with data collected at baseline, 3, 6, 9, and 12 months will be used. A convenience sample of 288 (96 per group) community dwelling women will be enrolled. Outcomes will be evaluated with self-report, behavioral performance, and bio-behavioral measures, including DXA and vitamin D. The expected outcomes are achievement of an increase in women's initiation and long term maintenance of osteoporosis self-management behaviors and stabilization of bone mineral density.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Repeated measures randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Striving | Experimental | Behavioral: StrivingStriving vs Boning-up \& Personal Choice |
| Boning-up Standard Education | Active comparator | Behavioral: Boning-UpBoning-up vs Striving and Personal Choice |
| Personal Choice | Sham comparator | Behavioral: Personal ChoicePersonal Choice vs Striving \& Boning-up |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy (able to participate in physical activity, not receiving medical care for chronic condition, not taking medications that would affect bone, greater than 5 years post treatment for cancer) not pregnant or lactating speaks and reads English consumes at least 200 mg less recommended amount of dietary calcium
Key exclusion criteria (1 listed)
- diagnosis of osteoporosis, history of fragile fracture, does not engage in vigorous activity more than 2 times a week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StrivingAlso: S2BS | Behavioural | Striving |
| Boning-Up | Behavioural | Boning-up Standard Education |
| Personal Choice | Behavioural | Personal Choice |
Primary outcome
Change in Bone Mineral Density
Time frame: Baseline and 12 months
Bone Mineral Density obtained via Dual Energy x-ray absorptiometry
8 secondary outcomes
Calcium Focused Food Diary
Time frame: Baseline, 3, 6, 9, and 12 months
Physical Activity Questionnaire (IPAQ)- Short Form: Measure of time and intensity of persons engagement in physical activity.
Time frame: Baseline, 3, 6, 9, and 12 months
Balance
Time frame: Baseline and 12 months
Stand Test
Time frame: Baseline and 12 months
6-minute walk test
Time frame: Baseline and 12 months
Functional Movement Screen (adaptation)
Time frame: Baseline and 12 months
Engagement in Self-regulation processes: "What are you doing today"/ DOTs
Time frame: Over 12 months a total of 284 text message were sent to each participant via newly designed app. Score included frequency of behavior and self-regulation process for 4 week periods over 12 months.
vitamin D
Time frame: Baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Polly A Ryan, PhD principal investigator
University of Wisconsin, Milwaukee
Questions about this trial
What is this clinical trial studying?
A study testing Striving, Boning-Up and Personal Choice in people with Osteoporosis and Health Behavior, run by University of Wisconsin, Milwaukee.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bone Mineral Density (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.