1. Explain proposed data collection methods
2. Explain proposed analytical approach
3. Describe the rationale For the study
Ready-to-eat cereals refer to breakfast cereals that are made from processed cereal grains and are often consumed in the form of breakfast in Western countries. These RTEC most often comprise of yogurt, fruits and milk, as well. In other words, RTEC are defined as major cereal foods that have been processed to an extent that they can be easily consumed without any preparation (1). These food products usually contain corn flakes and extruded cereals, in addition to cereal bars, oatmeal and muesli. Furthermore, RETC have often been categorized into food groups that manifest a longer shelf life and are inherently stable. Previous evidences have established the fact that companionship and convenience play an important role in reducing meal skips and also enhance the consumption of cereals (2).
Rationale- There is mounting evidence for the fact that eating breakfast helps in improving the micro- and macro-nutrient intake among people, when compared to skipping breakfasts. RETC also reduce the risks of gain in weight. However, there is inadequate evidence for their role in enhancing cognitive performance. Breakfast cereals are considered as the primary component of a perfectly balanced breakfast. These breakfast cereals include cooked cereals, porridge type of foods, RETC and/or cold breakfast (3). Requirement of healthy food and an awareness among the consumers has subsequently resulted in an increase in the overall demand for grains like rice, oats, and corn. The global demand for RETC is governed by the custom, habit, or faith of the buyers. The markets for RETC have huge growth potential (4).
Research question- Does RETC consumption improve the cognition, body weight and intestinal health among participants?
Research hypothesis- RETC will produce a positive impact on the body weight, cognitive skill and intestinal health.
- Evaluating the effects of RETC consumption on cognition
- Evaluating the impacts of RETC consumption on body weight
- Assessing the effects of RETC consumption on intestinal health
Reflection- The feedback for Part A of the assignment was taken into consideration by formulating an appropriate research question. This was facilitated by a thorough and extensive study of the systematic review that established a correlation between ready-to-eat cereals with the major health and nutritional outcomes among the consumers. Owing to the fact that the feedback stated that accurate gaps in the literature were not identified, I tried to investigate the benefits of RETC. Conducting an RCT, in place of a secondary research will help me find answers to the research question.
Adults belonging to the age group of 25-60 years will be recruited for the study. Participant enrolment process will begin by distributing templates and pamphlets at university, hospitals, healthcare clinics and community centres across the district. The inclusion criteria for the study would be those adults who are at a borderline for overweight and have been diagnosed with cholesterol levels, higher than the normal range. The subjects will also be excluded based on history of diabetes, cancer or renal disease. Furthermore, participants who will report loss of more than 5 kg weight in the past two months will be excluded. Use of any cholesterol medications will also be considered as an exclusion criteria. Following obtaining informed consent from all participants, after they are contacted over telephone to explain the purpose and adverse effects of the study, they will be randomised into two different groups. At least 50 participants will be selected by purposive sampling for the same (5).
The intervention group will be made to consume RETC daily during breakfast for a time period of eight weeks, and the control group will continue their normal dietary habits for the same time period. Following a wash out period of four weeks, there will occur a cross-over, and the trial will continue for the following eight weeks. Both the groups will be asked to adhere to normal diet during the time of wash out. The RETC meals that will be given to the intervention group will comprise of cornflakes and museli (60 gm), sprouted gain cereal (30 gm), along with skimmed milk (6). Fat-free yoghurt would also be added to the diet on alternate days. All the participants will be asked to maintain a food journal during the entire study. Adequate training will be provided to the participants for maintaining this record, and the process shall be facilitated by nursing professionals.
The high-density, low-density and serum cholesterol levels will be measured and recorded every weekend. Blood pressure shall be measured every day, with an automated sphygmomanometer, and will be noted down. Standardised methods will be used for assessing the weight and height of the patients every fortnight. pH electrodes will be used to measure faecal pH (7). Self-administered questionnaires on intestinal habits, defecations patterns and faecal consistency will be disseminated to all the participants. A sequence of computerized tasks based on standard psychometric measures will be used to determine the cognition levels. JAVA language will be used to program the tasks and the Bond–Lader mood scale will also be administered to the participants for assessing impact of RETC on cognition (8).
Ethical issues- A major ethical consideration that needs to be taken into consideration for the study is prior approval from the Institution Ethics Committee Board. Written informed consent shall be obtained from all participating adult. The participants will be ensured that their privacy and confidentiality will be safeguarded and no personal information shall be disclosed to any other person. Before conducting the trial, presence of equilibrium must be ensured, to gain a deeper understanding of the fact that one course of intervention is superior over another (9). Participants enrolled in both the groups should be provided the opportunity of obtaining enhanced health outcomes. The trial must be aimed at providing maximum benefits, with reduced or no risks. No kinds of therapeutic misconception must be present among the participants.
The SPSS version 21.0 will be used for determining the body weight, blood pressure, serum lipid levels, before and after the trial among both the groups. A t-test will also be conducted for determining the differences between the two groups, before the trial began. The population ratio method will also be employed for deriving the sum of the impact of the dietary components on each participant.
The primary strength of the research proposal lies in the fact that elevated levels of cholesterol have been found to play a major role in the onset and manifestation of hypertension and cardiovascular complications. The role of cholesterol reduction on the overall health and wellbeing of all people have been proved time and again. This study will develop a correlation between consumption of RETC and the cholesterol levels, thus unravelling its impact on associated comorbid conditions. Some of the major limitations of the study are linked to the purposive sampling procedure and the failure to blind the participants and the healthcare staff to the purpose of the trial. Purposive sampling might contribute to researcher bias. Lack of blinding might also influence the questionnaire responses (10).
Thus, it can be concluded that the proposal discussed above will be conducted with the objective of determining the benefits of eating ready-to-eat cereals and its direct impact on health outcomes and subjective wellbeing of a target population. Consuming RETC foods helps in preparing and eating breakfast within a short time span of 10-15 minutes. Furthermore, they are much easier to prepare and are widely available. Considering the fact that RETC breakfasts are more convenient and nutritious, the trial will help in effectively assessing whether these food products exert any influence on the body weight, cholesterol levels, and blood pressure.
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- Mohd Nasir MT, Nurliyana AR, Norimah AK, Jan Mohamed HJ, Tan SY, Appukutty M, et al. Consumption of ready-to-eat cereals (RTEC) among Malaysian children and association with socio-demographics and nutrient intakes–findings from the MyBreakfast study. Food & nutrition research. 2017 Jan 1;61(1):1304692.
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- Vargas SS, O’neil CE, Keast DR, Cho SS, Nicklas TA. Eating Ready-to-Eat Cereal for Breakfast is Positively Associated With Daily Nutrient Intake, but Not Weight, in Mexican-American Children and Adolescents: National Health and Nutrition Examination Survey 1999–2002. Nutrition Today. 2016 Jul 1;51(4):206-15.
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- Michels N, De Henauw S, Breidenassel C, Censi L, Cuenca-Garcí M, Gonzalez-Gross M, et al. European adolescent ready-to-eat-cereal (RTEC) consumers have a healthier dietary intake and body composition compared with non-RTEC consumers. European journal of nutrition. 2015 Jun 1;54(4):653-64.
- Rebello CJ, Johnson WD, Martin CK, Han H, Chu YF, Bordenave N, et al. Instant oatmeal increases satiety and reduces energy intake compared to a ready-to-eat oat-based breakfast cereal: a randomized crossover trial. Journal of the American College of Nutrition. 2016 Jan 2;35(1):41-9.
- Jones JM, Korczak R, Peña RJ, Braun HJ. CIMMYT Series on Carbohydrates, Wheat, Grains, and Health: Impact of Minerals, Phytochemicals, Specific Grain-Based Foods, and Dietary Patterns on Mild Cognitive Impairment, Alzheimer's Disease, and Parkinson's Disease. Cereal Foods World. 2017 May;62(3):104-14.
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