Introduction
The purpose of this assignment is to review and evaluate an academic journal article, as well as discuss how it might be applied to real-life scenarios. The article selected for review is titled “Effectiveness of Lifestyle Intervention for Individuals with Severe Obesity and Type 2 Diabetes” (Unick et al., 2011). This article uses results from the Look AHEAD trial which completed in 2012 and is currently in its follow up stage. The primary objective of the Look AHEAD trial was to “examine, in overweight [participants] with type 2 diabetes, the long-term effects of an intensive lifestyle intervention program designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity” (Look AHEAD, 2016).
The specific article I have selected used a specific subset of data from the trial for the purpose of determining the effectiveness of the intensive lifestyle intervention on people who are severely obese (BMI ≥ 40%) and have been diagnosed with type 2 diabetes. The Look AHEAD trial also tested for “reductions in the incidence of three secondary composite outcomes and examine the effect of the intervention on cardiovascular disease risk factors, diabetes control and complications, general health, and quality of life, and psychological outcomes. The cost and cost-effectiveness of the Lifestyle Intervention relative to Diabetes Support and Education will be assessed” (Look AHEAD, 2016). Some of which was not include in the data used by this study.
Article Summary
This section will summarize the article using the following subsections; purpose, participants, methods, and results.
Purpose
We all know that the obesity epidemic is getting worse and as such we need further treatments to combat this epidemic. The purpose of this study was to examine the effectiveness of an intense lifestyle intervention on weight loss, reduced risk of cardiovascular disease and program adherence of individuals with type 2 diabetes who were severely obese (BMI ≥ 40%). The study notes a few key pieces of information as to the purpose. It is noted that the rate of sever obesity is increasing faster than any other classification of obesity, the National Institute of Heath (of the US) suggests that people who are severely obese (BMI ≥ 40%) cannot be effectively treated with intense lifestyle changes and recommend surgical treatments such as bariatric surgery. However surgical treatment such as bariatric surgery is not an option for many people due to a number of factors. Only about 1% of people who are severely obese (BMI ≥ 40%) undergo surgical treatments in the US annually. It is also noted that most studies relating to lifestyle interventions to reduce BMI or increase heath in persons with a BMI ≥ 25% include participant inclusion criteria, or better described as exclusion criteria, that are too strict and not inclusive of persons with a BMI ≥ 40%.
Participants
This study used a specific subset of data from participants in the Look AHEAD trial. Specific data exclusion reasons are given below. The intensive lifestyle intervention included 5145 participants from 16 centers across the US. The inclusion criteria of the Look AHEAD trial required participants to have type 2 diabetes, aged 45 through 76 years, having a BMI ≥ 25%, or ≥ 27% if taking insulin, having a body weight < 400lbs, having a glycated hemoglobin (HbA1c) level of ≤ 11%, having a triglyceride level ≤ 600 mg/dL, and finally systolic and diastolic blood pressure ≤ 160 and ≤ 100 mmHg. The inclusion criteria also required that participants completed blood work, a maximum graded exercise test and a 2-week behavioural run in period. All participants also completed written informed consent.
The Look AHEAD trial did include a control group that did not have type 2 diabetes. Data including the participants from the control group were not included in this study. Participants not in the control group who had type 2 diabetes were also randomly separated into 2 groups. The first was a diabetes support and education group. The participants of this group attended 4 meetings throughout the year and received general recommendation to healthy eating and physical activity. This group of participants, generally referred to as the DSE group, were also excluded from the data used in this study. The second group of participants was those who were randomly selected to be in the intensive lifestyle intervention group, were generally referred to as the ILI group. The data associated to these specific participants were included and analyzed in this study. The participant’s data was grouped based on BMI category for comparative purposes. These BMI groupings included Overweight (BMI ≥ 25% and < 30%), Class I Obese (BMI ≥ 30% and < 35%), Class II Obese (BMI ≥ 35 and < 40%) and Severely Obese (BMI ≥ 40%). The resulting number of participants in the ILI group was 2,503.
Method
The lifestyle intervention was modeled after the Diabetes Prevention Program published by the American Diabetes Association. The participants in the ILI group were each given an individual goal to reduce overall body weight by 10% or more. However, the intervention was actually designed to reduce overall body weight by 7%. This program sets the prevention targets for individuals regarding body weight, cholesterol levels, including both high density lipoproteins (HDL) and low density lipoproteins (LDL), blood pressure, including systolic and diastolic levels, and HbA1c. The program may set other prevention targets however they are not included in this study. Participants were educated with various behavioural strategies to modify their eating and exercising behaviours. These were specifically targeted with the goal of weight loss. During the first 6 months, participants attended 3 group sessions per week. Participants also attended 1 individualized counseling session monthly with either a registered dietitian, a behavioural psychologist or exercise physiologist. During the months 7 through 12, participants attended 2 group sessions and 1 individual session per month.
Participants were prescribed a daily caloric goal ranging from 1,200 to 1,800 kcal per day. The prescribed amount was dependant on their body weight at the initial assessment. It was also recommended to restrict their consumption of fats to be less than 30% of their daily caloric intake. In some cases, participants received meal replacements to assist in meeting their daily caloric intake goals.
Participants were also given a home-based exercise plan. This plan, if adhered to, would increase the amount of moderate physical activity to be ≥ 175 minutes per week. An example of moderate physical activity provided included a brisk walk per a period of more than 10 minutes in duration. Participants were also given a pedometer to assist in tracking physical activity.
Behavioural techniques were also incorporated into the program to help participants achieve their goals of weight loss and physical activity. This included a toolbox strategy, consistent with the Diabetes Prevention Program. This toolbox consisted of behavioural strategies, including motivational interviewing and problem solving techniques. The toolbox also included the use of pharmacotherapy.
Pharmacotherapy was also used for participants who failed to reach their weight loss goal at 6 months. Orlistat was the drug that was prescribed. In the US this goes by the trade name Alli, and in Canada goes by the trade name of Xenical. Essentially, the primary purposes of this medication is “preventing the absorption of fats from the human diet by acting as a lipase inhibitor, thereby reducing caloric intake. It is intended for use in conjunction with a healthcare provider-supervised reduced-calorie diet” (HealthExpress.co.uk, 2016).
Participants also recorded information into weekly diaries which were turned in to be analyzed and later included in the trial data. The diaries included information in regards to the food consumed and physical activity performed during each week.
Assessments were conducted on the participants at the onset of the study. This ensured they met the inclusion criteria and so that baseline data could be captured. Weight, height, BMI, waist circumference and blood pressure were all assessed using standard procedures. Blood samples were collected from each participant and were tested by certified testing facilities. This included samples collected to measure HbA1c, fasting blood glucose, total triglycerides, HDL, and LDL. The use of pharmatherapy was also captured using standardized interviewer-administered questionnaires. Specifically, the use of insulin, lipid-lowering and blood pressure medications were tracked.
Physical activity was only assessed on a subsample of participants reporting the number of city blocks walked, flights of stairs climbed, and the duration and frequency of physical activity performed. This was completed using the Paffenbarger Physical Activity Questionnaire.
Cardiorespiratory fitness was assessed using a maximal graded exercise treadmill at baseline and submaximal at 1 year. The maximal graded test was terminated at the point of volitional fatigue or when the criteria from the American College of Sport Medicine were observed. At 1 year, a submaximal exercise test was performed and terminated when the participant reached a heart rate of 80% of maximum. If the participant was on B-blockers the test was terminated when a score of 16 was observe on the rating of perceived exertion scale. Cardiorespiratory fitness was defined as the estimated metabolic equivalent level (MEL). This was determined by a calculation of the speed and grade of the treadmill as well as when the termination criteria were met.
Results
All data analyses included in the results were repeated, excluding the very small number of participants who underwent bariatric surgery or used orlistat for consistency purposes.
Participants with a BMI ≥ 40% had a younger mean age and had a lower level of mean physical activity when compared to the other participants. A larger proportion of the participants were also female. Baseline values for cardiovascular factors were similar between all participants with the exception of systolic blood pressure which was higher for the participants with sever obesity.
Participants who were severely obese had the largest, yet similar, total body weight loss in comparison to the participants in the other BMI categories. It was noted that the participants who were severely obese and achieved at least a 5% weight loss at year 1 was 67%. This result was comparable to the participants in the other included BMI categories. The participants who were severely obese and achieved at least a 10% weight loss at year 1 was 39.2%. This result was comparable to the participants in the other included BMI categories except those participants who were in the overweight category. The number of these participants who achieved a weight loss goal of at least 10% was only 30.1%.
All participants in each BMI categories had similar improvements in absolute fitness and physical activity at year 1, however participants who were severely obese had lower levels of overall fitness and physical activity at the baseline. Their physical activity levels were also significantly lower at year 1 when compared to the participants in the other BMI categories. Similarly, participants who were severely obese had lower levels of absolute fitness at the baselines and lower than others at 1 year.
Favorable improvements for cardiovascular risk factors were identified including improvements in lipids, blood pressure, and glycemic control. This was achieved across all BMI categories. Participants in the severely obese category had reduced improvements of HDL levels compared to the participants in the other BMI categories. The number of participants using insulin, lipid-lowering, and hypertension medication was reduced similarly across all BMI categories. Participants who met the American Diabetes Associate goals for LDL, blood pressure, and HbA1c at year 1 compared to the baseline was significantly greater across all BMI categories. These levels raised from 35-45% at baseline to 70-75% at year 1.
In regards to program adherence, people who were severely obese attended 80% of the treatment sessions over the year which was similar to the other BMI categories. Similarly, meal replacement usage did not differ across BMI categories.
Article Evaluation
This information is relevant to this course as it deals with material already covered as well as material that may be covered later. The study deals with lifestyle interventions associated to people with type 2 diabetes and people that have have a BMI ≥ 25%. It also deals with the health risks associated these participants. This study is important because it gives evidence that persons with a BMI ≥ 40% can be effectively treated using a lifestyle intervention. This evidence contradicts what the National Institute of Heath suggests, which is that “the severely obese individuals with type 2 diabetes can be successfully treated through behavioural weight loss programs” (National Heart, Lung, and Blood Institute, 1998). It is also important because of the current obesity stats that are showing continuous rising of individuals in each BMI category, the greatest being seen for people who have a BMI ≥ 40%.
Because the study was conducted over only 1 year, the participants who were severely obese did not show a significant increase to overall fitness and physical activity. This could be due to limitations including physical and/or environmental and possibly the length of time that the trial was completed. The participants of this trial did not just wake up with a BMI ≥ 25%. It was something that was compounded over time. Similarly, to reduce BMI it also takes time. The study indicates that people who are severely obese perform little to none moderate-to-vigorous physical activity. Strategies should be developed to enhance physical activity for these individuals in a safe, healthy, and realistic way.
The primary cohort of participants in this study were mainly female and with a mean age of 57.86 years. Future studies should try to include similar amounts of males to females as well as to look at the effectiveness of a lifestyle intervention to other age groups, including children, adolescents, young adults, etc. This is especially important as children and youth have BMI percentages that are on the rise and the number of overweight children is now over 30% and rising faster than ever before.
Application of the Information
The information included in the article could be used with a number of real-life scenarios. This could include the creation of a localized support program for persons with a BMI ≥ 25%. More specifically though, programs for persons with a BMI ≥ 40% could have programs designed specifically for them as they have previously been excluded due to their BMI from most other programs. Such programs may already exist locally, provincially, or nationally. If so, modifications could be made based on the results from this article, such as alterations to the inclusion criteria, increasing the efficacy of the program and in the end help increase the overall health of a greater number people. These programs could also be customized to meet specific societal and cultural needs based on the region of execution and target participants. Examples of this could be to include education literature regarding foods available to that area or specific culture, such as Aboriginals who live on traditional lands, or individuals who live in the far north, where food selection could be quite different.
Behavioural therapy could also be considered as viable treatment option before undergoing bariatric surgery. This could possibly help in reducing the recovery time after surgery, or reduce the requirement of surgery altogether for some people. There are many people who either do not want to go for surgery, or simply cannot afford it. This article provides evidence shows that a lifestyle intervention could be used as an effective treatment method for all people with a BMI ≥ 25%.
An additional application would be to use some of these tools from the study within your own home, even if you have a BMI < 25%. All people should be able to find use from the education of individuals regarding healthy lifestyles. Individuals can use self-monitoring tools available within the community such as blood pressure sensors in pharmacies, or self-assessment tools regarding physical fitness to see if improvements could be made. This information could also be relayed to others in the individual’s life, such as family and friends. The more tools we all have to fight the obesity epidemic the more likely we will overcome it.
Conclusion
The study provided data analysis regarding the effectiveness of lifestyle interventions to individuals are severely obese and who have type 2 diabetes. It was shown that it is a viable option in increasing the participant’s health in many different ways. The Look AHEAD trial was a large trial by numbers of participants showing its importance to make changes to fight the obesity epidemic and the effectiveness of a lifestyle intervention. It also helps to identify future areas of study to increase our effectiveness in increasing one’s overall health and the wide range of effectiveness it could have for people with a BMI ≥ 25%.