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SCI: Preventing Overweight (2007)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
  1. To determine if total body electrical conductivity (TOBEC) is a reliable and valid technique for estimating body composition in SCI patients.
  2. To test if there is a significant difference in fat-free mass and body fat percentage between sedentary and physically active SCI subjects.
Inclusion Criteria:
  • SCI patients with chronic C6-L2 spinal cord transections whose injuries occurred a minimum of three years prior to data collection.
Exclusion Criteria:
  • Not stated.
Description of Study Protocol:

Recruitment

Not described

Design

Comparison, by level of activity (physically active or sedentary by questionnaire), of TOBEC and anthropometric measures in males with SCI at a single point in time

Blinding used (if applicable)

Not applicable 

Intervention (if applicable)

None

Statistical Analysis

  • Intraclass (alpha) reliability by repeated measure of ANOVA.
  • Construct validity by univariate analysis of variance.
  • Validity also by Pearson product-moment correlation (between TOBEC % body fat and sum of seven skinfolds)
Data Collection Summary:

Timing of Measurements

Once

Dependent Variables

  • Body weight (electronic scale)
  • Circumferences (plastic tape measure, 3/8" wide) - abdominal, calf, chest, hip, midparm, thigh, waist
  • Skinfold thicknesses (Lange skinfold calipers) - abdominal, anterior thigh, biceps, chest, subscapular, suprailiac, triceps
  • Supine length (top of head to end of heel, with pillow under knees)
  • TOBEC (2nd generation adult instrument chamber)

Independent Variables

  • physical activity level
  • SCI

Control Variables

none

Description of Actual Data Sample:

Initial N: 17 male SCI patients (12 active, 5 sedentary)

Attrition (final N): 17

Age: 23-43 years (mean 32.4)

Ethnicity: not mentioned.

Other relevant demographics: none mentioned

Anthropometrics:  (see results)

Location: Baylor College of Medicine GCRC, Houston, TX 

Summary of Results:
  1. The correlation between fat percentage measured by TOBEC and the sum of seven skinfolds was positive and significant (R=0.73, P<0.01). (e.g.: as skinfold thickness increased, so did % fat measured by TOBEC)
  2. There was no significant difference between active and sedentary groups in supine length, weight, supine weight-to-height ratios., circumferences, or skinfolds 
  3. Significant differences were found between groups when comparing body fat percentage and total fat mass measures.

Variables Active Sedentary     Significance
fat (%) 15.6±4.8 23.3±4.7 p<0.05
fat mass (kg) 11.2±4.8 16.8±4.0 p<0.05
fat free mass (%) 84.4±4.8 76.7±4.7 p<0.05

fat free mass (kg)

 

59.3±8.5

 

55.4± 4.4

 

NS

 

Author Conclusion:
  • The TOBEC was found to be an extremely reliable instrument for estimating fat percentage in SCI men.
  • High reliability estimates for single and multiple trials indicate the use of a single trial will provide reliable body fat estimates.
  • Average fat percentage and fat mass were significantly higher in sedentary compared to active subjects.
Funding Source:
Reviewer Comments:
  • Small sample size. However, the high reliability coefficients and construct validity supports the use of TOBEC in SCI subjects.
  • Small number of sedentary group. May not detect significances in certain measurements between active and sedentary groups.
  • Statistic analysis was appropriate, meeting the purpose of the study design.
Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? ???
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? ???
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? No
  2.4. Were the subjects/patients a representative sample of the relevant population? ???
3. Were study groups comparable? ???
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? ???
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) ???
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? Yes
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) ???
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? No
4. Was method of handling withdrawals described? N/A
  4.1. Were follow-up methods described and the same for all groups? N/A
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) N/A
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? N/A
  4.4. Were reasons for withdrawals similar across groups? N/A
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
5. Was blinding used to prevent introduction of bias? N/A
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? N/A
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) N/A
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? N/A
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? N/A
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? N/A
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? N/A
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? N/A
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? N/A
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? N/A
  6.6. Were extra or unplanned treatments described? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? N/A
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
7. Were outcomes clearly defined and the measurements valid and reliable? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? N/A
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? ???
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? N/A
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? Yes
  8.6. Was clinical significance as well as statistical significance reported? Yes
  8.7. If negative findings, was a power calculation reported to address type 2 error? No
9. Are conclusions supported by results with biases and limitations taken into consideration? ???
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? No
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? N/A
  10.2. Was the study free from apparent conflict of interest? N/A