Evaluation of a Standardized Wellness Protocol to Improve Anthropometric and Physiologic Function and to Reduce Health Risk Factors: A Retrospective Analysis of Outcome

Abstract

Objectives:

The objective of this study was to determine whether a standardized, commercial wellness protocol (Creating Wellness) that focuses on diet, exercise, vitamin supplementation, and one-on-one coaching improves anthropometric and physiologic function and reduces health risk factors.

Methods:

Using a retrospective analysis of subject data collected through a central data repository, several measures of anthropometric and physiologic function were analyzed for changes in outcome.

Results:

There were 197 private chiropractic clinics in the United States utilizing the Creating Wellness protocol in 2007. A total of 178 subjects completed an 18-week protocol and had initial and final assessments. All anthropometric and physiologic measures showed improvement following the intervention; therefore, this standardized wellness protocol was shown to improve weight, heart rate, blood pressure, strength, body–mass index, and forced vital capacity. Paired sample t tests and significance testing for the entire sample, and for both genders separately, determined that these changes were statistically significant.

Conclusions:

The Creating Wellness protocol leads to improved health risk factor outcomes based on improvement in anthropometric and physiologic measures in this study population. The results of these tests are generally accepted measures of risk for cardiovascular events, diabetes, metabolic syndrome, and cancer. There are little evaluative data on health outcomes related to programs designed to reduce risk of lifestyle-related diseases. For those clients utilizing the program evaluated in this study, there appears to be evidence suggesting improved health risk factor outcomes from participation in this specific protocol. The results of this study have implications related to a broad number of public health issues related to management of chronic lifestyle diseases.

Introduction

C hronic, lifestyle-based disease has been steadily replacing infectious disease as a significant cause of morbidity and mortality through the 20th century. At the same time, life expectancy is also on the rise and, cumulatively, these events have led to a rise in chronic degenerative conditions such as coronary heart disease, stroke, diabetes, arthritis, and other related diseases such as cancer. While there are genetic predispositions that are being explored, for the most part these conditions are primarily attributed to behaviors related to poor diet, nutrition, and lack of physical activity.¹

Health care stakeholders are attempting to adapt to these changes while at the same time grappling with the economic issues associated with ever-increasing health care expenditures.^1,2

Because the nature of these chronic diseases tends to be attributed to behaviors, a holistic approach has been advocated that involves regimens such as dietary, nutritional, physical, and psychologic practices that have been practiced for centuries.²

Health care providers have developed and aggressively market lifestyle interventions targeted at chronic lifestyle-based diseases and moving forward, it is increasingly important that consumers, providers, payers, and public health experts know which of these interventions produce beneficial outcomes.

In a wellness paradigm, illness—especially chronic illness—is viewed as the culmination of persistent and insidious behaviors that lead to poor health outcomes.³ The Creating Wellness commercial protocol that is the subject of this study incorporates a model of wellness care that integrates the physical, biochemical, and psychologic dimensions of health to address these behaviors (Table 1).

Table 1.

The Creating Wellness Intervention

The intervention encompasses physical, biochemical, and psychologic dimensions and each is customized based on the client's wellness goals, the completion of a health survey, and results of a physiologic evaluation. This process attempts to uncover areas in each aspect of the client's life needing attention.

Physical Dimension—Goals involve the development of a regular stretching, aerobic, and strength program. This is accomplished through:

• Six aerobic and strength-training instructional videos

• Workout ball

• Workout bands

Biochemical Dimension—Goals involve the development and eating of well-balanced meals, vitamin and mineral supplementation, and staying well hydrated. This is accomplished through:

• Customized meal planning

• Customized nutritional support (vitamin and mineral supplements)

Psychologic Dimension—Focus is on goal setting, taking action toward goals, problem solving, and taking care of oneself. This is accomplished through:

• One-on-one coaching

• Customized weekly CD audio program

• Personal wellness journal

• Weekly goal checklist

According to several expert panels, a lifestyle modification approach that includes a reduced-calorie diet along with increased physical activity is the treatment cornerstone for obese and overweight individuals.⁴ Such lifestyle modifications appear to be beneficial across the spectrum of what is considered to be lifestyle diseases.

While there is widespread belief and anecdotal evidence that such lifestyle modifications reap rewards in terms of health outcomes, reviews of several major popular commercial weight-loss programs seem to have exposed a lack of scientific, peer-reviewed evidence from these programs.^5,6

Despite this, in a meta-analysis of the effect of exercise on fitness among adults with diabetes, Nielsen et al. found that larger effect sizes were associated with exercise prescription, fitness testing, supervised exercise, group sessions, and longer duration exercise sessions.⁷ Commercial fitness programs will tend to have all or some of these components, so it appears they have the potential to be exploited and used as a method to address chronic, lifestyle diseases.

In a study of weight loss and its relationship to pulmonary function in older sedentary, obese men, Womack found that weight loss led to changes in static lung volumes.⁸ Also looking at lung function, Yeh et al. studied vital capacity and found low forced vital capacity (FVC) to be independently associated with indicators of the insulin-resistance syndrome and an independent predictor of type 2 diabetes.⁹

In terms of weight reduction, Maffiuletti et al. report on a longitudinal study involving a 3-week body weight reduction program consisting of a high-protein, low-carbohydrate diet, aerobic and strength training, counseling, and nutrition-related education. At follow-up, study participants (including 45 women and 19 men) had higher percentage fat-free mass, muscle strength, high-density lipoprotein cholesterol, and physical activity levels. Additionally, they had lower total cholesterol and glucose levels.¹⁰

Counseling is typically provided in commercial weight-loss programs as part of a multifaceted approach. Raatz et al. evaluated the benefit of diet instruction by registered dietitians and frequency of weigh-in visits on weight-loss success. They found that dietary instruction led by registered dieticians was more beneficial than frequent weigh-in visits alone.¹¹

In the Look AHEAD study, researchers looked at the effects of an intensive lifestyle program on body weight, blood glucose control, treadmill testing, blood pressure, and cholesterol on 5145 adults between 45 and 74 years of age with type 2 diabetes. The lifestyle group was guided by medical professionals and was compared to a control group that received routine care from their own doctors with the addition of three group diabetes education sessions per year.

The lifestyle group increased their physical activity, attended personal diabetes education sessions, group sessions, and did meal replacements. After 1 year, the lifestyle group lost an average of 8.6% of their body weight compared to the control group, which averaged less than 1%. Glycosylated hemoglobin, treadmill tests, blood pressure, and cholesterol improved as well.¹²

In another study evaluating a fitness program (physical activity and educational sessions) in a psychiatric population, Cormac et al. reported reduction in weight, body–mass index (BMI), and waist size coupled with increased hand strength, flexibility, lung function, and aerobic capacity following a 12-week program.¹³

While commercial programs are highly criticized for not providing evidence of effectiveness, Finley evaluated retention rates and weight loss in a commercial program (Jenny Craig) and found that those who remained in the program for 40–52 weeks lost 12%–7.2% of their body weight and concluded that weight loss was greater in those who remained in the program longer.¹⁴

In a military study of a wellness approach to weight loss, researchers reported on a 1-year program they described as an intensive lifestyle change approach.¹⁵ They utilized a cognitive behavioral approach with exercise and nutritional changes. They reported average weight loss of more than 10 pounds for men and 14 pounds for women along with an increase in healthy eating attitudes, well-being, and quality of life.

In an evaluation of a community-based weight control program, Culos-Reed et al. found significant improvement in body weight, measurements, physical activity, and nutritional intake following the introduction of a multidimensional lifestyle behavior change program consisting of group educational sessions, cognitive behavioral strategies, and twice-weekly physical activity sessions.¹⁶

The PREMIERE study consisted of a randomized controlled trial looking at the effects of comprehensive lifestyle modification on diet, weight, fitness, and blood pressure control. Elmer et al. concluded that persons with hypertension can sustain multiple lifestyle modifications that improve the control of blood pressure and that could reduce the risk of chronic disease. They examined weight, heart rate, and physical activity level, comparing outcomes between two multicomponent interventions with an advice-only group. Both behavioral interventions significantly reduced weight, fat, and sodium intake.¹⁷

Burke et al. recruited subjects in Australia with a BMI of greater than 25 kg/m² who were being treated with one or two antihypertensive drugs for at least 3 months. They instituted a multifactorial, cognitive-based program to modify lifestyle and demonstrated an improved diet, increased physical activity, decreased weight, and improvement in blood lipid patterns at 4 months.¹⁸

The previous study is significant because while hypertensive drug therapy influences the incidence of stroke, it has only modest effects on coronary artery disease.¹⁹ For this reason, lifestyle modification has become an indispensable part of the management of hypertension.²⁰ However, lifestyle modification presents a challenge due to the difficulty in creating behavior change.²¹ As a result, cognitively based programs along with those having a multifactorial emphasis have shown some success.^22
–24

One such study of 975 subjects with hypertension incorporated a process for the withdrawal of drug and demonstrated the successful withdrawal of drugs in 79% of subjects, with long-term control of blood pressure remaining satisfactory in 40% of those patients.²³ A 3-year follow-up revealed no increased risk of cardiovascular events for those not taking medication.²⁵

As in the case of hypertension, pharmacotherapy has been suggested as a last resort in the treatment of metabolic syndrome when lifestyle changes including dietary, weight control, and increased physical activity fail to improve these parameters in those individuals at high risk for coronary heart disease.²⁶

This review of literature shows promise for intense, cognitive behavioral programs that emphasize comprehensive lifestyle modifications to improve fitness, impart wellness, and reduce the risks and effects of chronic lifestyle-based diseases. While the literature did not reveal a single, specific unifying protocol, it did provide a theme that includes intensive, comprehensive lifestyles changes that include exercise, diet, nutrition, and one-on-one support. The lack of studies exploring commercially based programs is troubling, and this study can help fill this void while also communicating the benefits of central data repositories for such studies.

Methodology

This retrospective study utilized data collected from the central data repository of a commercial wellness program called Creating Wellness. A cohort of clients from 197 private chiropractic clinics in the United States that utilize Creating Wellness were involved in this study and data from a sample of subjects who completed an 18-week program of diet, exercise, vitamin supplementation, and coaching during 2007 were analyzed for changes in outcome following completion of the program. Clients who began the program but did not complete it were excluded.

Several measures were analyzed for changes in outcome, including the following:

Weight

Resting heart rate

Systolic and diastolic blood pressure

Strength

BMI

Body fat

Waist circumference

FVC

The intervention in this study is a commercial wellness protocol consisting of the establishment of baseline measures of the above items with three follow-up assessments performed over 18 weeks. Interventions include meal planning, nutritional support through vitamin and mineral supplementation, aerobic and strength training, psychologic support provided through one-on-one coaching, and audio programs (Table 1).

Some subjects also received chiropractic care during the program. All of the participating clinics practice a form of chiropractic that involves management of vertebral subluxation. This application of chiropractic is not solely directed at spinal manipulation for the treatment of neuromusculoskeletal pain syndromes. It is based on the contention that misalignments and/or abnormal motion of vertebral motion units may compromise neural integrity and may influence organ system function and general health and well-being.²⁷ Chiropractic care of this type has been shown to improve self-reported quality of life and to correlate with improved health behaviors such as improving diet, taking up exercise, and quitting smoking.²⁸ The records related to the chiropractic intervention are not part of the central data repository, so it was not possible to control or consider the effects of the chiropractic intervention in this study.

Results

Characteristics of the sample

There were a total of 180 subjects who completed the 18-visit protocol and had initial and final assessments. These subjects represented clients from 54 of the 197 operational clinics.

Two (2) subjects were removed from the data analysis. One (1) subject was removed because there was no heart rate data reported for the final assessment. Another subject was removed because it was determined that the results recorded for waist size were likely not possible and therefore deemed the result of a data-entry error. This left data from 178 subjects, representing 54 clinics available for analysis.

Descriptive statistics for age and gender were generated. In addition, paired sample t tests were completed for the first and last assessments for the entire sample as well as for females and males separately.

Descriptive statistics revealed a mean age of 50.9 with a standard deviation of 12.885. The youngest subject was 19 and the oldest was 83. The mean age of female subjects was 51.2 and the mean age of male subjects was 49.7 (Table 2).

Table 2.

Age and Gender Distributions

Sample	Frequency	Percent	Mean age	SD	Min	Max
Women	152	85.4	51.2	12.7	19	83
Men	26	14.6	49.7	13.9	22	80
Entire sample	178	100	50.98	12.8	19	83

SD, standard deviation.

There were a total of 152 female subjects representing 85.4% of the sample and 26 male subjects representing 14.6% of the sample (Table 2).

Statistical analysis

Mean values for the first and last assessments for the entire sample and for men and women separately (Tables 3 –5) were obtained for each physiologic measure.

Table 3.

Comparison of First to Last Assessment: Entire Sample

Measurement	Assessment 1	Assessment 4	Percent improvement	Mean diff.	Sig.
Weight	195.67 lb	186.06 lb	4.9%	9.610	<0.05
Systolic BP	127.52 mm Hg	121.62 mm Hg	4.6%	5.899	<0.05
Diastolic BP	83.35 mm Hg	77.70 mm Hg	6.8%	5.657	<0.05
Seated HR	77.05 bpm	72.63 bpm	5.7%	4.414	<0.05
BMI	32.08	30.45	5.1%	1.636	<0.05
Body fat	38.90%	36.67%	5.7%	2.230	<0.05
Waist	38.87 in.	36.92 in.	5%	1.952	<0.05
FVC	2.65 L	2.96 L	11.5%	−0.3060	<0.05
Arm strength	86.69 lb	126.19 lb	45.6%	−39.500	<0.05
Leg strength	144.11 lb	192.43 lb	33.5%	−48.320	<0.05
Torso strength	119.06 lb	161.99 lb	36.1%	−42.933	<0.05

Sig., significance; BP, blood pressure; HR, heart rate; bpm, beats per minute; BMI, body–mass index; FVC, forced vital capacity.

Table 4.

Comparison Between First to Last Assessment: Men Only

Measurement	Assessment 1	Assessment 4	Percent improvement	Mean diff.	Sig.
Weight	232 lb	219.74 lb	5.3%	12.258	<0.05
Systolic BP	135.85 mm Hg	128.38 mm Hg	5.5%	7.462	<0.05
Diastolic BP	86.27 mm Hg	78.35 mm Hg	9.2%	7.923	<0.05
Seated HR	78.45 bpm	70.77 bpm	9.8%	7.681	<0.05
BMI	33.04	31.25	5.4%	1.79431	<0.05
Body fat	30.44%	28.43%	6.6%	2.00539	<0.05
Waist	44.13 in.	41.64 in.	5.6%	2.5000	<0.05
FVC	3.41 L	3.77 L	10.8%	−0.3692	<0.05
Arm strength	130.54 lb	199.23 lb	52.6%	−68.692	<0.05
Leg strength	250.77 lb	305.08 lb	21.7%	−54.308	<0.05
Torso strength	204.12 lb	276.35 lb	35.4%	−72.231	<0.05

Sig., significance; BP, blood pressure; HR, heart rate; bpm, beats per minute; BMI, body–mass index; FVC, forced vital capacity.

Table 5.

Comparison Between First to Last Assessment: Women Only

Measurement	Assessment 1	Assessment 4	Percent improvement	Mean diff.	Sig.
Weight	189.46 lb	180.30 lb	4.8%	9.157	<0.05
Systolic BP	126.10 mm Hg	120.47 mm Hg	4.5%	5.632	<0.05
Diastolic BP	82.86 mm Hg	77.59 mm Hg	6.1%	5.270	<0.05
Seated HR	76.81 bpm	72.95 bpm	5.0%	3.856	<0.05
BMI	31.92	30.31	5.0%	1.60971	<0.05
Body fat	40.35%	38.08%	5.6%	2.26866	<0.05
Waist	37.97 in.	36.12 in.	4.9%	1.8586	<0.05
FVC	2.5 L	2.8 L	11.7%	−.2952	<0.05
Arm strength	79.19 lb	113.70 lb	43.6%	−34.507	<0.05
Leg strength	125.87 lb	173.16 lb	37.6%	−47.296	<0.05
Torso strength	104.51 lb	142.43 lb	36.3%	−37.921	<0.05

Sig., significance; BP, blood pressure; HR, heart rate; bpm, beats per minute; BMI, body–mass index; FVC, forced vital capacity.

All measures showed improvement following the intervention with mean values for the entire sample decreasing for weight, blood pressure, heart rate, BMI, body fat, and waist size. Additional analysis, for men and women separately, yielded similar improvements. Mean values for FVC, arm, leg, and torso strength all increased (Tables 3 –5).

To test the null hypothesis that there is no difference between the average pre- and postintervention values, paired sample t tests for the entire sample and for females and males separately were conducted. In addition, significance testing at the 95% confidence interval (CI) was performed to determine whether any changes were statistically significant (Tables 3 –5).

None of the CIs contain 0 and all p values are less than 0.05, indicating that the changes are statistically significant. Therefore, it is possible to reject the null hypothesis that the difference in the population means is 0 and accept the alternative hypothesis that there is a significant difference in the pre- and postintervention values.

Summary

All anthropometric and physiologic measures showed improvement following the intervention; therefore, this standardized wellness protocol was shown to improve weight, heart rate, blood pressure, strength, BMI, and FVC. Paired sample t tests and significance testing for the entire sample, and for both genders separately, determined that these changes were statistically significant.

Discussion

This study sought to determine whether a wellness protocol involving diet, exercise, vitamin supplementation, and coaching had a beneficial effect on well-accepted measures of health. While there are numerous anecdotal reports regarding various programs directed at weight loss and cardiovascular disease prevention, there is a need for more evidence to substantiate these protocols. Outcomes from this study suggest that dietary modification, aerobic and strength training coupled with vitamin supplementation, and one-on-one coaching led to a significant improvement in health risk factor outcomes.

These results provide additional evidence for such multifaceted interventions in general and for this protocol specifically. It is recommended that further studies and additional analysis of these data be completed in order to more deeply explore these findings as well as address this study's limitations. Such studies could include exploring changes from one risk category to another; differences in outcome among subjects who are concomitantly taking medication and/or receiving chiropractic care; additional demographic evaluation on outcomes exploring age, race, and socioeconomic status; self-reported quality of life; and the relationship to other commonly used measures of risk and outcome.

Limitations of the study include its design as a retrospective analysis with no control group. Given the large number of clinics, individual differences in program administration among clinics could not be accounted for, although each clinic is using the same commercial program and all have been trained in person by company representatives. In addition, individual differences in compliance or noncompliance with individual aspects of the protocol could not be accounted for. One additional factor that could not be accounted for is that these subjects may have received chiropractic care throughout the program and there is no accounting for the specificity of the chiropractic intervention (i.e., frequency, duration, type, etc.). Finally, this study cannot determine whether other behaviors and other elements of life course affected the outcomes in this cohort.

Despite the limitations, there are a large number of subjects undergoing the program through a large number of providers and there are multiple health assessments that provided robust data to work with.

The burden of disease has shifted from infectious to chronic diseases based primarily on lifestyle. With the move toward evidence-based practice, it is becoming increasingly important to know which interventions directed at reducing the risks and effects of these lifestyle choices produce beneficial health risk outcomes.

There is widespread belief that engaging in physical exercise, modifying diet, taking vitamins, and cognitive therapy either singly or taken together lead to reduced risk of lifestyle-based, chronic diseases. These beliefs are accompanied by anecdotal testimonials from the lay public and by marketing reports from commercial enterprises that market products and programs to consumers and patients.

Unfortunately, there is little evaluative data on these programs. For those clients utilizing the program evaluated in this study, there appears to be evidence suggesting improved health risk outcomes from participation. Since these tests are generally accepted measures of risk for cardiovascular events, diabetes, metabolic syndrome, and cancer, the results of this study have implications related to a broad number of public health issues.^{9,10,12,17,22,26,29

–33} For example, in the case of blood pressure, health-related lifestyle modifications are the standard of care and it is important that practitioners have interventions at their disposal that have evidence of effectiveness. Considering the concerns related to adverse drug events and emerging evidence that intensive lifestyle changes may obviate their need, these findings, and others like them, should be given serious attention. The results of this study demonstrate that the noninvasive protocol highlighted here may be an effective method of reducing those factors that contribute to risks related to cardiovascular disease, diabetes, metabolic syndrome, and cancer.

Conclusions

Based on the analysis of data in this study, active engagement in exercise, dietary modification, and nutritional and psychologic support leads to improved health risk factor outcomes. Furthermore, the measures evaluated in this study are generally accepted measures of risk for cardiovascular events, diabetes, metabolic syndrome, and cancer.^{9,10,12,17,22,26,29

–33}

Given the positive findings, it is recommended that further studies and additional analysis of these data be completed, including how many of the subjects who underwent the protocol changed from one risk category to another, whether there are differences in outcome among subjects who are concomitantly taking medication, and whether age, race, or socioeconomic status has any bearing on outcomes.

Self-reported quality of life, other commonly used measures of risk and outcome such as cholesterol levels, C-reactive protein, and glycosylated hemoglobin should be explored. Randomized controlled trials and observational studies are suggested to explore many of these questions.

Footnotes

Disclosure Statement

No competing financial interests exist.

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