Outline
The unprecedented rise of obesity in recent years has presented one of the greatest challenges to society and the health sectors in specific (Picot, Jones, Colquitt, Gospodarevskaya, Lovemen & Baxter, 2009). It has been associated with the consumption of carbonated drinks sweetened with sugar, which have a high glycaemic index and are energy-dense, coupled with the sedentary lifestyle among many families in recent years to be the major cause of the pandemic (Picot et al.2009).
Even though numerous evidence shows that controlled and managed effectively, similar studies show that non-surgical interventions using single strategies are not effective. But hope is seen in some other studies that have on the other round shown that a combination of these intervention procedures such as exercise, dietary and behavioral therapy can lead to improved results. However, the combined multifaceted approach does not have any data to back it in terms of cost-benefit analysis. This proposed study is intended to produce such data.
Introductions
The recent rise in obesity among young adults and children to epidemic level in recent years has posed the greatest threat to the public hence concern to the healthcare providers, public health professionals, and society as a whole (Picot, Jones, Colquitt, Gospodarevskaya, Lovemen & Baxter, 2009). In the United States, 17% of adolescents and children are defined as overweight, a condition that is directly associated with obesity prevalence (Jiang et al., 2005).
A United States data show that the number of adolescents with the body mass index of 95th percentile for ages 12 and above has risen from 15.5% to 23.4% in particular ethnic minorities. Why is there an unprecedented rise in obesity pandemic among young adults? Many experts attribute this fact to the increased consumption of carbonated drinks sweetened with sugar, which have a high glycaemic index and are energy-dense, coupled with the sedentary lifestyle among many families in recent years (Picot et al., 2009; Jiang et al., 2005). However, several pieces of evidence have shown that it can be controlled and managed effectively.
This proposal is meant to investigate the cost-benefit analysis of the multifaceted approach that involves behavioral therapy and good dietary habit as non-surgical means of managing the obesity pandemic among young adults. The investigation is expected to fill the knowledge gap on the cost of combining these non-surgical processes concerning the success of the process, to give the rationale whether implementing such a program would be viable or not.
Problem Statement and Background of Problem
Controlling obesity through single non-surgical approaches such as frequent physical activities promotion, dietary modification as well reduction of sedentary lifestyle behaviors have proved futile as an insignificant result has been realized against what was expected by earlier researchers. Young adults (14-21-year-olds) are prone to consumption of junk food and leading a sedentary lifestyle, dictated by the modern environment of little space for exercise.
Again, even though surgery poses positive results, especially for severe cases of overweight and obesity, the adverse complications (e.g. pulmonary embolism), side-effects (e.g. heartburn) and some death-related cases have raised concerns among stakeholders (Colquitt, Picot, Loveman & Clegg, 2009). The shortcomings of surgery as an option have led to the reviews (including the above) that have revealed that the combined non-surgical approaches of exercise plus diet change or behavioral therapy can offer the best alternative for the overall treatment of obesity and weight loss effectively and safely. But the discrepancy for this multifaceted approach is aggravated by the fact that there is insufficient information on the cost of such a program in the relation to the outcome.
Statement of the Purpose of the Study
The purpose of this study would be to examine if obese young adults can lose their weight without the adverse complications and side effects by exercise combined with diet change or behavior therapy instead of surgical interventions at a feasible cost. Obesity in adolescents will be defined as the proportion of adolescents with a body mass index at or above the 95th percentile for age (Chanoine, Hampl, Jensen, Boldrin, Hauptman, 2005).
Research Questions
The research question would be “what’s the cost of combined non-surgical intervention for obesity management among obese young adults concerning the outcome (14 to 21-year-olds)?” Outcomes will be measured change in BMI included changes in the waist and hip circumferences, weight loss, and lipid measurements. Weight loss is seen as the ultimate solution for reducing obesity not only in young adults but also among the entire population at risk of obesity. The resultant cost will be analyzed concerning the outcome, compared, and contrasted to the cost of single or separate intervention process costs.
Expected Result
This proposed research is expected to influence the nursing practice to improve the overall health status of future adults and society as a whole, by reducing obesity prevalence. The medical cost for treating obesity and overweight is expected to be known once the results are adopted and practiced logically so as to ensure the feasibility of such an intervention approach is known.
Methodology
Participants
Participants will be recruited at institutions with well-established young adults and pediatric obesity treatment programs and clinical research expertise mostly schools and pediatric health centers because these places offer a reliable environment for the young adult, thus influencing their behaviors and attitudes towards the activities as found out in the review. The recruitment of patients will be through advertisements to be posted in clinics and through spontaneous replies to newspaper advertising all over the United States. This is to ensure there is proper randomization with the team selected.
The target group is adolescents between the ages of 14 and 21 since this group is prone to consumption of junk food and leading a sedentary lifestyle, dictated by the modern environment of little space for exercise as shown by the review. The criteria for selecting the study group will be as follows: if they
- have a body mass index of two units or higher than the US weighted mean for the 95th percentile based on age and sex,
- those who will have one of their parents or guardians prepared to attend study visits with them, and
- those who will be willing to actively participate in behavior modification program.
According to the review, it is apparent that this will be the first long-term study investigating the impact of the combined non-surgical interventions that is comprised of exercise with diet change or behavioral therapy. 2 units will be added to the 95th percentile of BMI to ensure that only patients with the greatest potential for benefiting from study participation are included.
Exclusion criteria will be body mass index of 44 or higher (to increase the homogeneity of the group); body weight of 130 kg or higher or less than 55 kg; weight loss of 3 kg or higher within 3 months prior to screening; diabetes requiring anti-diabetic medication; obesity associated with genetic disorders; history or presence of psychiatric disease; use of dexamphetamine or methylphenidate; active gastrointestinal tract disorders; ongoing bulimia or laxative abuse; and use of anorexiants or weight-reduction treatments during the 3 months before randomization Savoye (et al., 2007).
Research Design
The study is a quantitative survey on the impact of the multifaceted non-surgical approach to weight reduction on young adults. It will be a 54-week, multicenter, placebo-controlled study from January 2010 to March 2012 at 16 centers located in the United States. The participants from these 16 centers will be randomized during this intervention period to ensure balanced selection. General guidelines for diet, exercise, and behavioral modification will be supplied to all centers involved in the study, but each center remains free to use its own strategy during this study period. Again, the study does not have specific guideline criteria for monitoring compliance (Savoye et al., 2007).
The process of screening will involve physical examination that consists of Tanner stage assessment; vital signs and physical measurements (weight, height, waist, and hip circumference); and clinical laboratory tests (i.e. hematology, blood chemistry, vitamin levels, glucose, and insulin responses to a 2-hour oral glucose challenge) (Savoye et al., 2007). “Vital signs” will be taken and the measurements of weight and height will take place after every 2 weeks for the first 4 months, and then every month until the end of the study (9 visits in total) (Savoye et al., 2007). The waist and hip circumference will be measured after every month in the first 4 months and then the successive measurements after every 2 months are expected to follow until the end of the study (Savoye et al., 2007).
Tanner stage will be graded based on breast development in girls and genital development in boys. Each center will report the cost of the program from its inception to implementation. The daily drawn blood samples after an overnight fast will be analyzed at the central laboratory (Savoye et al., 2007). The radiology technicians will be required to follow specific guidelines to ensure that standard operating procedures are adhered to in all 16 centers. Each center will report the total cost for each intervention to ensure proper data is revealed.
Diet
Nutritionally maintained participants will be balanced with the proper design of the hypocaloric, launched to produce an initial measured weight loss every week (Savoye et al., 2007). The distribution of the calories in diet will be 30%of fat (10% saturated, 10% monounsaturated, and 10% polyunsaturated; 70 g/d maximum), 50% as carbohydrate, and 20% as protein to represent the recommended diet according to the nutritional guidelines that require an estimated standard of 40% caloric intake (Savoye, Shaw, Dziura, Tamborlane, Rose, et al., 2007).
Maximum cholesterol and calcium intakes will be 300 mg/d and 1300 mg/d, respectively and the level of caloric requirements will be determined by sex and baseline body weight, using estimates of total energy requirements based on the World Health Organization’s equations for basal metabolic rate20 and corrected for activity (Savoye, et al., 2007; Wake, 2009). Assigned caloric intake will range from 1400 kcal/d (bodyweight _70 kg) to 1800 kcal/d (bodyweight_100kg) in boys and from 1200 to 1600 kcal/d in girls (Savoye, et al., 2007).
Some adjustments will be needed daily for caloric intake will also be during the double-blind treatment period if the participant reached a BMI of 22 or if the participant loses weight too rapidly (1 kg per week) (Savoye et al., 2007). At each study visit, the dietician will confirm with the patient whether they are in compliant compliance with diet or the whether situation (Savoye et al., 2007). Participants in both treatment groups will receive a commercially available daily multivitamin supplement throughout the active period of the study (Savoye, et al., 2007). The cost of each item and process will be recorded over the entire period. Collecting dietary data in this way has been shown to provide comprehensive results and thus is expected to provide appropriate information on the cost of intervention.
Behavioral Modification
All study centers will have behavioral modification programs in place. However, a study-specific manual as a guideline will be used. Generally, it will involve the recording of the observed food intake and activity; “limiting high-calorie and high-fat foods in the household”; restricting food intake to the dining area at meal times; slow eating process; complete avoidance of snack; encouraging participants to understand their cues for overeating; substituting new behaviors for overeating; and reducing television watching and instead encourage alternative activities that are more physical (Dennison et al., 2004; Savoye et al., 2007). Staff at the study centers will be expected to support and reinforce behavioral modification techniques regularly to ensure the process is run according to plans (Dennison et al., 2004).
After randomization, young adults and their parents/guardians who attend only 3 days per week will be dropped except for the day of the week when the intervention will be provided (Shaw, Gennat, O’Rourke, & Del Mar 2006). The same will apply to the centers that do not show any commitment to the programs. Thus, the final sample expected to be available for analysis is expected to represent a true picture of the findings at the baseline level. The attention of the participants will be kept alive through musical activities; with healthy eating sessions designed to reduce children’s television viewing (provided during the second year of study) (McMillan-Price, Petocz, Atkinson, O’Neill, Samir, Steinbeck, et al., 2006). Here again, the cost of the whole process will be recorded simultaneously.
Exercise Counseling
There are specific guidelines to be provided so as to encourage regular physical activity and reduce sedentary behavior so as the work relations maybe he/she sitting (McMillan-Price et al., 2006). Strength, flexibility, and aerobic activities will be involved as part of the exercise plan wherever possible and according to McMillan-Price, et al. (2006) behavioral psychologists will speak with patients about compliance with the exercise program at each study visit.
Efficacy Parameters
The parameters to be used are the change in BMI from baseline to study end for the primary efficacy while a change in body weight, levels of total, high-density lipoprotein, and low-density lipoprotein cholesterol, a ratio of low-density lipoprotein to high-density lipoprotein cholesterol, triglyceride levels, systolic and diastolic blood pressure, waist and hip circumference, glucose and insulin responses to an oral glucose challenge, and changes in body composition entailed secondary efficacy (Savoye et al., 2007).
Safety and Cost Parameters
The participants will be systematically questioned on the presence of gastrointestinal tract adverse effects at each level, using a specially designed dictionary of standard terms for defecation patterns for reproducibility and consistency of reporting (Savoye, et al., 2007). Any adverse event will be discussed at each subsequent visit until resolution is reached. For adverse events extending beyond the end of the study, the participants will be contacted 4 weeks after the last visit to assess the outcome; all adverse events will be considered resolved at the time of the last contact with the participant (Savoye et al., 2007).
Other safety parameters to be measured directly are both physical and sexual maturation, levels of the vitamin, levels of sex hormone, gallbladder and renal structure, cardiac function, and bone mineral content (Savoye et al., 2007). Each process will be followed by the recording of the total cost per intervention measured in relation to the impact created. The recording is to be tabulated accordingly for ease of reference and a more comprehensive analysis.
Statistical Analysis
There is a plan to enroll about 450 individuals who would provide more than 80% power to detect a difference of 1 BMI unit, with an assumption that 30% dropout will occur. Central randomization of patients will be done according to a computer-generated randomization schedule. The process established will be “triple-blind and the allotted treatment group will be obtained through an automated telephone system” (p.6). The safety population will involve all randomized participants who will receive “at least 1 dose of study drug and have at least 1 follow-up assessment” (O’Brien, Dixon, Laurie, et al., 2006).
Efficacy will be assessed in a modified intent to treat population, comprising all randomized participants with a baseline assessment and at least 1 post-baseline efficacy measurement (O’Brien, Dixon, Laurie, et al., 2006). The analysis of the “efficacy level will be performed by the use of the last observation carried forward method for those who dropped out. Primary and secondary efficacy analyses on the other hand will be performed using mixed-model analysis of variance (O’Brien, Dixon, Laurie, et al., 2006).
It is important that the test in “Between-group treatment differences with 95% confidence intervals and P values” be calculated based on least-squares means (O’Brien, Dixon, Laurie, et al., 2006, p.28, p.3). “Weight and BMI to be corrected for age and sex by Z score based on Centers for Disease Control and Prevention charts (O’Brien, P.E., Dixon J.B., Laurie, et al. 2006).
Secondary quantitative will be analyzed by applying repeated-measures analysis of variance (O’Brien, Dixon, Laurie, et al., 2006). “Change from baseline will be analyzed using center, treatment, and treatment by center as covariates” (p.19) All analyses will be performed using SPSS statistical software that will be appropriate and available. Finally, the average of the total costs for all the interventions will be tabulated and calculated.
The study will be conducted following good clinical practice, the laws and regulations of the United States in which the research will be conducted. The institutional review board approval will be needed at each participating center. Parents and guardians will be required to give written informed consent and assent.
Limitations
There is a likelihood of misreporting of the costs for particular interventions since the study relies on the information given by the respective institutions. This may be attributed to the fact that some institutions may inflate the figures with the expectation that they will get funding for future similar projects. Again, it may be difficult to measure the cost of television viewing control as reported by the parents in terms of monetary value (Dennison, Russo, Burdick, & Jenkins, 2004; O’Brien, Dixon, Laurie, et., 2006). This is because it is the parents who will be reporting to schools and the research team, an assignment that is not expected to be paid.
The busy schedules for the parents or the guardians are likely to jeopardize some of the most important potential participants hence locking out some good data sources. This may be as a result of the parents changing jobs or losing their jobs. The other technicality may arise from other areas as parents divorcing or separating thus destabilizing the particular student’s participation by each parent likely to move from one location to another (James, Thomas, Cavan & Kerr, 2004).
The other limitation could be as a result of the relatively small sample size as compared to the United States population size. It is therefore expected that larger and a more intensive study that would involve the analysis of the cost of all the interventions in a broader perspective with all the stakeholders in place are to be analyzed and more representative data revealed to ensure homogeneity rather than diversity since as studies have shown, some ethnic groups are more vulnerable than others hence there must be different levels of interventions in terms of both costs and resultant impacts.
Reference List
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Shaw, K. A., Gennat H.C., O’Rourke P., & Del Mar C. (2006). Exercise for overweight or obesity. The Cochrane Database of Systematic Review, Issue 4. Art. No. CD003817. Web.
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