Assignment: Randomized Controlled Trial

Assignment: Randomized Controlled Trial

Statistical Technique in Review

Most research reports describe the subjects or participants who comprise the study sample. This description of the sample is called the sample characteristics, which may be presented in a table and/or the narrative of the article. The sample characteristics are often presented for each of the groups in a study (i.e., intervention and control groups). Descriptive statistics are calculated to generate sample characteristics, and the type of statistic conducted depends on the level of measurement of the demographic variables included in a study (Grove, Burns, & Gray, 2013). For example, data collected on gender is nominal level and can be described using frequencies, percentages, and mode. Measuring educational level usually produces ordinal data that can be described using frequencies, percentages, mode, median, and range. Obtaining each subject’s specific age is an example of ratio data that can be described using mean, range, and standard deviation. Interval and ratio data are analyzed with the same statistical techniques and are sometimes referred to as interval/ratio-level data in this text.

Research Article

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Source

Oh, E. G., Yoo, J. Y., Lee, J. E., Hyun, S. S., Ko, I. S., & Chu, S. H. (2014). Effects of a three-month therapeutic lifestyle modification program to improve bone health in postmenopausal Korean women in a rural community: A randomized controlled trial. Research in Nursing & Health, 37(4), 292–301.

Introduction

Oh and colleagues (2014) conducted a randomized controlled trial (RCT) to examine the effects of a therapeutic lifestyle modification (TLM) intervention on the knowledge, self-efficacy, and behaviors related to bone health in postmenopausal women in a rural community. The study was conducted using a pretest-posttest control group design with a sample of 41 women randomly assigned to either the intervention (n = 21) or control group (n = 20). “The intervention group completed a 12-week, 24-session TLM program of individualized health monitoring, group health education, exercise, and calcium–vitamin D supplementation. Compared with the control group, the intervention group showed significant increases in knowledge and self-efficacy and improvement in diet and exercise after 12 weeks, providing evidence that a comprehensive TLM program can be effective in improving health behaviors to maintain bone health in women at high risk of osteoporosis” (Oh et al., 2014, p. 292).

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Relevant Study Results

“Bone mineral density (BMD; g/cm2) was measured by dual energy x-ray absorptiometry (DXA) with the use of a DEXXUM T machine . . . . A daily calibration inspection was performed. The error rate for these scans is less than 1%. Based on the BMD data, the participants were classified into three groups: osteoporosis (a BMD T-score less than −2.5); osteopenia (a BMD T-score between −2.5 and −1.0); and normal bone density (a BMD T-score higher than −1.0)” (Oh et al. 2014, p. 295).

“Characteristics of Participants

The study participants were 51–83 years old, and the mean age was 66.2 years (SD = 8.2). The mean BMI was 23.8 kg/m2 (SD = 3.2). Most participants did not consume alcoholic drinks, and all were nonsmokers. Antihypertensives and analgesics such as aspirin and acetaminophen were the most common medications taken by the participants. Less than 20% of participants had a regular routine of exercise at least three times per week. Daily calcium- and vitamin D-rich food intake (e.g., dairy products, fish oil, meat, and eggs) was low. Seventy-five percent (n = 31) of the participants had osteoporosis or osteopenia. There were no differences in the baseline characteristics of the groups (Table 2). The adherence rate to the TLM program was 99.6%” (Oh et al., 2014, p. 296).