Clinical trial NCT03405103: Striving to be Strong: Self-management
Official title: Efficacy of m-Health Self-Management Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Health Behavior
Keywords: self-management
m-Health
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
Collaborators: name: Marquette University
name: Medical College of Wisconsin
First posted: 2018-01-19
Enrollment: 290
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Repeated measures randomized clinical trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Bone Mineral Density
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Calcium Focused Food Diary
timeFrame: Baseline, 3, 6, 9, and 12 months
measure: Physical Activity Questionnaire (IPAQ)- Short Form: Measure of time and intensity of persons engagement in physical activity.
timeFrame: Baseline, 3, 6, 9, and 12 months
measure: Balance
timeFrame: Baseline and 12 months
measure: Stand Test
timeFrame: Baseline and 12 months
measure: 6-minute walk test
timeFrame: Baseline and 12 months
measure: Functional Movement Screen (adaptation)
timeFrame: Baseline and 12 months
measure: Engagement in Self-regulation processes: "What are you doing today"/ DOTs
timeFrame: 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.
measure: vitamin D
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Milwaukee
name: Polly A Ryan, PhD
role: PRINCIPAL_INVESTIGATOR
References: