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Striving to be Strong: Self-management (S2BS)

Primary Purpose

Osteoporosis, Health Behavior

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Striving
Boning-Up
Personal Choice
Sponsored by
University of Wisconsin, Milwaukee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring self-management, m-Health

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Sham Comparator

    Arm Label

    Striving

    Boning-up Standard Education

    Personal Choice

    Arm Description

    Striving vs Boning-up & Personal Choice

    Boning-up vs Striving and Personal Choice

    Personal Choice vs Striving & Boning-up

    Outcomes

    Primary Outcome Measures

    Change in Bone Mineral Density
    Bone Mineral Density obtained via Dual Energy x-ray absorptiometry

    Secondary Outcome Measures

    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 .
    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.
    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.
    Stand Test
    Leg strength: time it takes participant to stand and sit ten times, Measured in seconds.
    6-minute walk test
    Functional Status: measure of distance walked in 6 minutes. Measured in feet and inches
    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.
    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
    vitamin D
    serum vitamin D level measured in nmole/L

    Full Information

    First Posted
    January 6, 2018
    Last Updated
    January 24, 2018
    Sponsor
    University of Wisconsin, Milwaukee
    Collaborators
    Marquette University, Medical College of Wisconsin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03405103
    Brief Title
    Striving to be Strong: Self-management
    Acronym
    S2BS
    Official Title
    Efficacy of m-Health Self-Management Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2012 (Actual)
    Primary Completion Date
    May 15, 2016 (Actual)
    Study Completion Date
    June 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Wisconsin, Milwaukee
    Collaborators
    Marquette University, Medical College of Wisconsin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis, Health Behavior
    Keywords
    self-management, m-Health

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Repeated measures randomized clinical trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    290 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Striving
    Arm Type
    Experimental
    Arm Description
    Striving vs Boning-up & Personal Choice
    Arm Title
    Boning-up Standard Education
    Arm Type
    Active Comparator
    Arm Description
    Boning-up vs Striving and Personal Choice
    Arm Title
    Personal Choice
    Arm Type
    Sham Comparator
    Arm Description
    Personal Choice vs Striving & Boning-up
    Intervention Type
    Behavioral
    Intervention Name(s)
    Striving
    Other Intervention Name(s)
    S2BS
    Intervention Type
    Behavioral
    Intervention Name(s)
    Boning-Up
    Intervention Type
    Behavioral
    Intervention Name(s)
    Personal Choice
    Primary Outcome Measure Information:
    Title
    Change in Bone Mineral Density
    Description
    Bone Mineral Density obtained via Dual Energy x-ray absorptiometry
    Time Frame
    Baseline and 12 months
    Secondary Outcome Measure Information:
    Title
    Calcium Focused Food Diary
    Description
    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 .
    Time Frame
    Baseline, 3, 6, 9, and 12 months
    Title
    Physical Activity Questionnaire (IPAQ)- Short Form: Measure of time and intensity of persons engagement in physical activity.
    Description
    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.
    Time Frame
    Baseline, 3, 6, 9, and 12 months
    Title
    Balance
    Description
    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.
    Time Frame
    Baseline and 12 months
    Title
    Stand Test
    Description
    Leg strength: time it takes participant to stand and sit ten times, Measured in seconds.
    Time Frame
    Baseline and 12 months
    Title
    6-minute walk test
    Description
    Functional Status: measure of distance walked in 6 minutes. Measured in feet and inches
    Time Frame
    Baseline and 12 months
    Title
    Functional Movement Screen (adaptation)
    Description
    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.
    Time Frame
    Baseline and 12 months
    Title
    Engagement in Self-regulation processes: "What are you doing today"/ DOTs
    Description
    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
    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.
    Title
    vitamin D
    Description
    serum vitamin D level measured in nmole/L
    Time Frame
    Baseline and 12 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Female
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Polly A Ryan, PhD
    Organizational Affiliation
    University of Wisconsin, Milwaukee
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Undecided

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