Case Study Of Research And Evidence In Practice

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Running head: RESEARCH AND EVIDENCE IN PARCTICE
RESEARCH AND EVIDENCE IN PRACTICE
Name of the Student
Name of the University
Author note

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1RESEARCH AND EVIDENCE IN PRACTICE
The article used- Gardner, C. D., Trepanowski, J. F., Del Gobbo, L. C., Hauser, M. E.,
Rigdon, J., Ioannidis, J. P., ... & King, A. C. (2018). Effect of low-fat vs low-carbohydrate
diet on 12-month weight loss in overweight adults and the association with genotype
pattern or insulin secretion: the DIETFITS randomized clinical trial. Jama, 319(7), 667-
679.
Summary of the nature, aim and hypothesis of the study
In order to obtain a successful weight loss the most important requirement is the
modification of the diet. A diet plan which is working on a particular person may not work on
others, so in order to lose weight successfully each and every person have to prepare their
respective diet plan by considering the specific requirements of the body. This article has done
researches on how the diet of a person changes according to the requirements of the body. The
aim of this study was to define the result of a well low fat diet and a well low carbohydrate diet
on the changes in weight and also to define whether the pattern of genotype or the insulin
secretion are linked with the on losing in weight or not (Abbasi, 2018). The hypotheses behind
this research study is that the in order to lose weight whether a healthy little fat diet is more
effective or a healthy little carbohydrate diet is more active. The variability of the weight
response of the weight loss suggest that some policies may work better for specific individuals
than the others and that no single diet should be considered as the universal one (Gardner et al.,
2016). The researchers of this paper considered the pattern of genotype and the insulin level
might be associated with the weight loss. The primary hypotheses was that a chief diet change
and genotype pattern interaction is effective in losing weight. The second chief hypothesis of this
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2RESEARCH AND EVIDENCE IN PRACTICE
study was that an important diet change and insulin secretion can reduce weight effectively. The
secondary outcomes of this study is comprised anthropometric measures, levels of the plasma
lipid, levels of insulin and glucose and the level of blood pressure.
Summary of the methods used in the study
The study design of this experiment was randomized control trial, where the participants
were randomly selected into strong low fat diet group and a healthy low carbohydrate diet group.
The researchers aimed to select 600 participants using the media advertisements. The main
criteria for the exclusion of the participants are hypertension or any other metabolic diseases
including diabetes, renal, cancer or liver diseases or being pregnant. Individual were excluded
who were taking hypoglycemic, anti-hypersensitive and psychiatric medications. The
randomization to a strong low fat or healthy low carbohydrate diet was performed by allocating
following computerized random programs. The method of the experiment involved a one month
run in period during which time the participants were given instructions to maintain their normal
diet, level of physical activity and also body weight. During the time of the experiment, 22
instructional sessions were taken which were involved within the part of the interventions.
Dietician health educators used to teach the participants about the healthy low fat food and
healthy low carbohydrates food. The main goal of the study was achieving maximal variation in
the eating of carbohydrates among the two groups while the other goal was to maintain equal
intensity of treatment and emphasizing on the providing foods and beverages of high quality.
The participants of the study were given instructions to decrease the eating of total fat or
carbohydrates which can be digested to 20 gms per day during the first 8 weeks. The foods
which derive the energy from carbohydrates and fats were asked to reduce. The participants of
the intervention of low fat foods were asked to take edible oils, whole fat dairy, nuts and fatty
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3RESEARCH AND EVIDENCE IN PRACTICE
meats and the participants of the intervention of healthy low carbohydrates were instructed to
take cereals, rice, grains, starchy vegetables, legumes and grains. The individuals started adding
fats and carbohydrates slowly into their diets by increasing 5 to 15 g/d per week till they reached
the lowermost level of eating that they thought could be maintained. Both of the diet groups were
given instructions to increase the intake of vegetables, reduce the increase of added sugars,
advanced flours and trans fats and emphasis on the foods that were slightly processed, full of
nutrients and preferably are prepared at home (Barnard, Levin & Yokoyama, 2015). All of the
participants were initiated to follow the exercises recommended by the doctors. The health
educators of the participants also emphasized on the emotional consciousness and the behavior
variation for supporting the dietary adherence and the loss of weight. The strategies to modify
the behavior includes supported principles of the self-regulatory changes which are based on
social cognitive theories.
Findings of the study
The main findings of the experiment was to define that the whether the healthy low fat
diet or the healthy low carbohydrate diet is more effective in reducing weight of obese people.
The researchers also considered insulin secretion and pattern of genotype to responsible for the
change in weight. The whole experiment were conducted by following the hypotheses and the
outcomes that were expected from the experiment. The expenditure of the total energy was
evaluated by using the Standford Seven Day Physical Activity Recall questionnaire. The
genotype pattern and the insulin secretion were assessed for testing the interaction. Out of 27
possible 3 locus genotypes 15 were detected with 1% or more frequency of genotype in the
previous samples of adults. The genotypes which have several locus were gathered into those
projected to be more sensitive to fat, more subtle to carbohydrate or sensitive to none of the

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genotypes. The main theory was addressed for a 12 months change in weight by changing the
diet, diet along with the genotype plus diet along with baseline INS-30. All of the hypotheses
were addressed using the linear and generalized effective models. All of the applied principles
were intended for treatment. Scientist generally base hypothesis based on the observations of
previous experiments. The validity of the analysis are dependent on the assumption that the
outcome data that are missing to follow up are not valid or unrelated. The hypothesis about diet,
hypothesis about genotype and were tested before applying in the experiment. Among the
selected participants, 185 of the individuals were eliminated who were not classified under the
low fat genotype design or the low carbohydrate pattern of genotype. The participants were
excluded from analysis of the genotype for the first hypothesis.
Threats to the external as well as internal validity to the randomized control
trial
The randomized control trials should be valid internally (means the conduct and the
design of the experiment should eliminate the chances of bias) and externally (mean the result of
the experiment should be relevant to the definable group of the patients. The clinicians of the
RCT most frequently criticize the external rationality of the randomized control trial. The
potential external threats to the randomized control trials are that, the results obtained from the
experiment are not always relevant but sat the same time the experiment should be planned in
such a way so that it allows the clinician to judge to whom the results were applicable (van
Deudekom et al., 2017). The other issues which hampers the external validity involves the
settings of the experiment which involves the country and the recruitment of the primary,
secondary and the tertiary care. Another issue which effect the external validity is the
recruitment of the patients or the participants. The researchers may face certain bias while
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selecting the patients by following the inclusion and the exclusion criteria. The outcomes which
are expected are also potential threat to the randomized control trials (Zhang et al., 2015)
The two most important threats to the internal validity are random error and biases. The
bias here cam be defined as the systematic error which lead to the deprivation of results to flaws
in the design (Flannelly, Flannelly & Jankowski, 2018). The four main sources of the occurrence
of bias are the detection bias, selection bias, performance bias and the attrition bias. The
systematic bias are controlled by the randomization. The detection bias may occur if the
assessment of the outcome of the experiment is affected by the membership of the individual
who has been assessed. The performance bias is the result of the consequences of the differences
with in the intergroup regarding the intervention or the exposure factors which are not related
with the intervention (Garattini et al., 2016). The attrition bias happens when the differences in
the number of participants who drops out from the study among the groups of the experiment.
The random error may happen because of any error with respect to the testing of hypothesis
(Elmunzer, 2015). The researchers of this experiment have faced threats to both the internal and
external validities while conducting the experiment (George et al., 2016).
Suggestions for resolving the threats
The threats of the randomized control trials is very difficult to resolve however, the
researchers may prevent the occurrence of bias to certain extent (Garattini et al., 2017). The
investigators must expect and examine all the confounders which are important for the outcome
studied (de Bruin, McCambridge & Prins, 2015). The researchers must use an appropriate
manner of randomization and allocation revelation and also report these methods in their trial
(Allcott, 2015).
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Reference
Abbasi, J. (2018). Interest in the ketogenic diet grows for weight loss and type 2
diabetes. Jama, 319(3), 215-217. doi: 10.4103/1008-682X.137687
Allcott, H. (2015). Site selection bias in program evaluation. The Quarterly Journal of
Economics, 130(3), 1117-1165.doi.org/10.1093/qje/qjv015
Barnard, N. D., Levin, S. M., & Yokoyama, Y. (2015). A systematic review and meta-analysis of
changes in body weight in clinical trials of vegetarian diets. Journal of the Academy of
Nutrition and Dietetics, 115(6), 954-969.doi.org/10.1016/j.jand.2014.11.016
de Bruin, M., McCambridge, J., & Prins, J. M. (2015). Reducing the risk of bias in health
behaviour change trials: improving trial design, reporting or bias assessment criteria? A
review and case study. Psychology & health, 30(1), 8-34.
doi.org/10.1080/08870446.2014.953531
Elmunzer, B. J. (2015). Increasing the impact of randomized, controlled trials in gastrointestinal
endoscopy. Gastroenterology, 149(3), 521-525.doi.org/10.1053/j.gastro.2015.07.022
Flannelly, K. J., Flannelly, L. T., & Jankowski, K. R. (2018). Threats to the internal validity of
experimental and quasi-experimental research in healthcare. Journal of health care
chaplaincy, 24(3), 107-130. doi.org/10.1080/08854726.2017.1421019
Garattini, S., Jakobsen, J. C., Wetterslev, J., Bertele, V., Banzi, R., Rath, A., ... & Eikermann, M.
(2017). Evidence-based clinical practice: overview of threats to the validity of evidence
and how to minimise them. Medicina Fluminensis: Medicina Fluminensis, 53(4), 424-
438. doi.org/10.21860/medflum2017_187362
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Garattini, S., Jakobsen, J. C., Wetterslev, J., Bertelé, V., Banzi, R., Rath, A., ... & Eikermann, M.
(2016). Evidence-based clinical practice: overview of threats to the validity of evidence
and how to minimise them. European Journal of Internal Medicine, 32, 13-21.
doi.org/10.1016/j.ejim.2016.03.020
Gardner, C. D., Offringa, L. C., Hartle, J. C., Kapphahn, K., & Cherin, R. (2016). Weight loss on
lowfat vs. lowcarbohydrate diets by insulin resistance status among overweight adults
and adults with obesity: A randomized pilot trial. Obesity, 24(1), 79-86.
doi.org/10.1002/oby.21331
George, B. J., Beasley, T. M., Brown, A. W., Dawson, J., Dimova, R., Divers, J., ... & Kim, M.
Y. (2016). Common scientific and statistical errors in obesity research. Obesity, 24(4),
781-790. doi.org/10.1002/oby.21449
van Deudekom, F. J., Postmus, I., van der Ham, D. J., Pothof, A. B., Broekhuizen, K., Blauw, G.
J., & Mooijaart, S. P. (2017). External validity of randomized controlled trials in older
adults, a systematic review. PloS one, 12(3), e0174053.
doi.org/10.1371/journal.pone.0174053
Zhang, X., Wu, Y., Ren, P., Liu, X., & Kang, D. (2015). The relationship between external and
internal validity of randomized controlled trials: A sample of hypertension trials from
China. Contemporary clinical trials communications, 1, 32-38.
doi.org/10.1016/j.conctc.2015.10.004
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