- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03405103
Striving to be Strong: Self-management (S2BS)
Efficacy of m-Health Self-Management Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- diagnosis of osteoporosis, history of fragile fracture, does not engage in vigorous activity more than 2 times a week
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Striving
Striving vs Boning-up & Personal Choice
|
Other Names:
|
Active Comparator: Boning-up Standard Education
Boning-up vs Striving and Personal Choice
|
|
Sham Comparator: Personal Choice
Personal Choice vs Striving & Boning-up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Bone Mineral Density
Time Frame: Baseline and 12 months
|
Bone Mineral Density obtained via Dual Energy x-ray absorptiometry
|
Baseline and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Calcium Focused Food Diary
Time Frame: Baseline, 3, 6, 9, and 12 months
|
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 .
|
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
|
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.
|
Baseline, 3, 6, 9, and 12 months
|
Balance
Time Frame: Baseline and 12 months
|
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.
|
Baseline and 12 months
|
Stand Test
Time Frame: Baseline and 12 months
|
Leg strength: time it takes participant to stand and sit ten times, Measured in seconds.
|
Baseline and 12 months
|
6-minute walk test
Time Frame: Baseline and 12 months
|
Functional Status: measure of distance walked in 6 minutes.
Measured in feet and inches
|
Baseline and 12 months
|
Functional Movement Screen (adaptation)
Time Frame: Baseline and 12 months
|
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.
|
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.
|
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 |
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
|
serum vitamin D level measured in nmole/L
|
Baseline and 12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Polly A Ryan, PhD, University of Wisconsin, Milwaukee
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01NR013913-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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