MNT: Disorders of Lipid Metabolism (2015)
A rally was held to inform employees about Health FirstSM. Flyers and posters were used to recruit participants.
Prospective intervention pilot study that used pre-post design to evaluate results.Intervention
- For each participant:
- Baseline questionnaire was used to gather information including self-reported smoking, exercise habits and use of medication (cardiovascular and diabetic)
- Questionnaires were used to discover where individuals were at in the transtheoretical model
- The cognitive behavior theory was used to make individuals aware of habits, with ideas to change behavior to healthier habits provided in educational sessions and RD counseling
- Anthropometric data and blood work was done at baseline and post-program
- Three individual coaching sessions were given based on the participant's needs and included use of appropriate health behavior theories. Each session was led by a RD after the RD reviewed the participant's blood work (at baseline and post-program), and weight and blood pressure measurements were taken after the midpoint
- Goals were set and the participant was encouraged to work on health issues important to him or her
- Was encouraged to join a team-based competition where the team logged in points for weight loss, attendance at the weekly sessions, for meeting exercise goals, achieving health goals and for completion of baseline and post-evaluations.
- Was able to view their anthropometric measurements and blood work on the Health FirstSM website
- Had access to the Health FirstSM website, where they could view all teams total points, download educational materials and watch PowerPoint presentations from the live sessions
- Program details:
- Over the first four weeks, group informational sessions were held for all employees during the lunch hour. Sessions included proper nutrition and healthy eating, portion control, snacking, exercise, metabolic syndrome and optional food plans such as the DASH diet and Mediterranean food plan
- Then four more weekly lunch sessions were held. At week 12, biometric measurements were repeated; blood was drawn for another hematological analysis and participants received a final coaching session from an RD
- An awards ceremony was held to recognize winning teams and provide incentives to those who completed the program.
- Statistical Analysis Software (SAS) version 9.1 was used for data entry
- Paired samples T-test was used to evaluate the significance of changes in the dependent variables from baseline to completion of the program
- The Bonnferroni correction equation was used to protect against Type 1 error rate; the level of significance was set at P<0.005
- Frequency procedures were performed in BMI and BP categories to demonstrate improvements in each classification
- Blood pressure classifications had to be coded for completion of the Friedman's test (normal=1; pre-hypertension=2; Stage 1 hypertension=3; Stage 2 hypertension=4). Three time periods for blood pressure classification (baseline, mid-point, post) were compared with Friedman's test. The test statistic for this test is the Cochran-Mantel-Haenszel (CMH) statistic.
- A post hoc test was performed on the three time periods to determine which time periods were significantly different.
Timing of Measurements
- At baseline and week 12, blood pressure, anthropometric measures and blood work were done, including:
- Weight changes
- Blood pressure
- Fasting blood glucose
- Waist circumference
- Total cholesterol
- LDL cholesterol
- HDL cholesterol
- Smoking habits.
- At the program's midpoint, an RD measured weight and an RN measured blood pressure.
- Anthropometric variables (weight, BMI, waist circumference, hip circumference and height measurements using a stadiometer) were measured by two graduate dietetic students
- Blood pressure (BP) was measured by registered nurses
- Blood work (total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride levels and FBG, non-fasting blood glucose and HgA1C if FBG was elevated) was measured by a vendor, Impact Health, via finger-stick blood draws
- The Health FirstSM software automatically calculated BMI and BP categories
- Participants' self-reported data on smoking habits, cardiovascular and diabetic prescription medication use, and exercise participation.
The program itself.
No designated control group. Participants served as their own control.
Initial N=10098 current employees and two retirees enrolled.
Attrition (final N)
- A total of 95 completed the program
- Reasons for not completing the program included:
- Disability leave
- Being transferred.
- A total of 87 met criteria to be eligible for data analysis:
- Completed all initial, midpoint and final anthropometric and blood work measurements
- Completed pre-evaluation and post-evaluation assessments
- Attended at least six of eight weekly sessions
- Exercised at least six weeks
- Received three individual coaching sessions.
- Older than age 60 years: 13 (14.9%)
- Ages 51 years to 60 years: 15 (17.2%)
- Ages 41 years to 50 years: 30 (34.5%)
- Ages 31 years to 40 years: 20 (23%)
- Under age 30 years: Nine (10.3%).
Other Relevant Demographics
- Completed the program: 95 (44 males and 51 females)
- Met criteria for data analysis: 87 (39 makes and 48 females).
- Family history of hypertension: 43 (49.4%)
- Heart disease: 35 (40.2%)
- Diabetes: 31 (35.6%)
- Cancer: 30 (34.5%)
- No family history for any of the conditions asked: 16 (23.9%).
BMW of North America, LLC located in Philadelphia.
|Variable||N||Mean Difference||SD||T-Score||95% CI|
|BP Diastolic||74||3.16**||8.39||3.24||(1.22, 5.11)|
|BP Systolic||74||3.84**||9.82||3.36||(1.56, 6.11)|
|HDL Cholesterol||74||-2.01||8.44||-2.05||(-3.97, -0.06)|
|LDL Cholesterol||72||-0.25||24.73||-0.09||(-6.06, 24.73)|
|Total Cholesterol||74||-2.54||24.1||-0.91||(-8.12, 24.73)|
|BMI Category||Frequency and Percent|
|Initial (N=95)||Final (N=87)|
|Normal||23 (24.2%)||24 (27.59%)|
|Pre-obese||37 (38.95%)||37 (42.53%)|
|Class I||24 (25.26%)||19 (21.84%)|
|Class II||7 (7.37%)||5 (5.75%)|
|Class III||4 (4.21%)||2 (2.30%)|
|BP category||Frequency and Percent|
|Initial (N=91)||Final (N=76)|
|Normal||22 (24.2%)||38 (50.0%)|
|Pre-hypertension||50 (54.9%)||28 (36.8%)|
|Stage 1||17 (18.7%)||9 (11.8%)|
|Stage 2||2 (2.2%)||1 (1.3%)|
- Paired T-tests demonstrated significant reductions in weight (P<0.0001), body mass index (P=0.0047), waist circumference (P< 0.001), diastolic blood pressure (P=0.0018) and systolic blood pressure (P=0.0012)
- Paired T-tests for total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides and fasting blood glucose did not indicate any significant improvements
- There was an improvement in body mass index and blood pressure classifications after completion of the program
- A Friedman's test of blood pressure classification demonstrated significant improvements in participants' blood pressure classification from pre-program to mid-point, mid-point to end, and pre-program to end
- Based on the post hoc test, all three-time periods differences were significant, with the order of the mean rankings getting increasing smaller from the pre-time period to post-time periods.
|Metabolic syndrome criteria||14 met criteria.||Six (43%) were no longer at risk.|
|Smoking habits||Seven reported smoking.||Four quit smoking, two reduced how much they smoked and only one had no change.|
|Blood pressure medication usage||15 report being on BP medications.||Four participants stated they reduced their BP medication use, three reported they stopped taking BP medication.|
|Cholesterol medication usage||10 report being on cholesterol medications.||One individual reported decreasing cholesterol medication after the end of the program.|
|Diabetes medication usage||Five report taking medication to control diabetes.||Two reported decreased use, while one reported discontinued use of diabetic medication.|
|Self-improved eating habits*||61 (91%) participants self-reported improved eating habits.
Five (7.5%) were unsure if eating habits changed.
One (1.5%) indicated no change in eating habits.
|Self-improved exercise* habits||56 (83.6%) participants states they improved exercise habits.
Seven (10.4%) were unsure if physical activity level changed.
Four (6%) indicated no change in exercise.
* Only 67 participants responded to post-evaluation questions about improved eating and exercise habits compared to before the program.
- No participant ethnicity or funding source were described
- There was mention of those participants who decreased meds but no mention of any patients who increased medication dosages (by their primary care physician) that would have improved lab values at the end of the 12 weeks
- Changes in eating habits were reported via questionnaire: There was no use of food diaries or recalls to have a better measurement of intake changes
- No description of smoking cessation methods and no indication if those particular participants had worsening eating habits to impact study results.
Quality Criteria Checklist: Primary Research
|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|
|1.||Was the research question clearly stated?||Yes|
|1.1.||Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?||???|
|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?||Yes|
|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?||No|
|2.2.||Were criteria applied equally to all study groups?||Yes|
|2.3.||Were health, demographics, and other characteristics of subjects described?||Yes|
|2.4.||Were the subjects/patients a representative sample of the relevant population?||???|
|3.||Were study groups comparable?||Yes|
|3.1.||Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)||N/A|
|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.)||Yes|
|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.)||N/A|
|3.6.||If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?||N/A|
|4.||Was method of handling withdrawals described?||Yes|
|4.1.||Were follow-up methods described and the same for all groups?||Yes|
|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%.)||Yes|
|4.3.||Were all enrolled subjects/patients (in the original sample) accounted for?||Yes|
|4.4.||Were reasons for withdrawals similar across groups?||Yes|
|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?||No|
|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.)||No|
|5.3.||In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?||???|
|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?||Yes|
|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?||Yes|
|6.4.||Was the amount of exposure and, if relevant, subject/patient compliance measured?||Yes|
|6.5.||Were co-interventions (e.g., ancillary treatments, other therapies) described?||No|
|6.6.||Were extra or unplanned treatments described?||No|
|6.7.||Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?||Yes|
|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?||Yes|
|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?||No|
|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?||???|
|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)?||No|
|8.5.||Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?||No|
|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?||Yes|
|9.1.||Is there a discussion of findings?||Yes|
|9.2.||Are biases and study limitations identified and discussed?||Yes|
|10.||Is bias due to study's funding or sponsorship unlikely?||???|
|10.1.||Were sources of funding and investigators' affiliations described?||No|
|10.2.||Was the study free from apparent conflict of interest?||???|