The Effect of Diet and Exercise - Research Proposal Example

1.2 PROJECT DESCRIPTION: Provide a brief outline of the project, including what participants will be required to do. This description must be in everyday language which is free from jargon. Please explain any technical terms or discipline-specific phrases. (No more than 350 words) The main objective of the study is to compare the effect of diet and exercise between a self help and structurally intervened group. The participants of the study would be over weight obese woman in the age group of 25 to 60 years. A total of 60 participants would be selected and would be divided as control – the self help group and study- the intervened group. Both the groups’ participants would be provided with weight reductio0n tips on diet and exercise, and to the study group it would be reinforced once in every two weeks. The result would be studied at the end of 8 weeks in control and once in two weeks for study group. My tutor said: As we discussed before a proposal is in the future tense. Participants Over weight and obese women (n = 60) (body mass index, 25-40) aged 19to 64 years. The candidates found suitable (after have undergone BMI check) would then be requested to sign the informed consent form and would be provided with a information sheet about the research. Written informed consent and medical history would also be obtained from all participants. The eligibility criteria for women is to be fixed as, body mass index ranging from 25 to 40 kg/m2 and age ranging from 19 to 64 years. Women with various afflictions whose treatment involves weight loss would also be considered. The patients for the study would be selected by two methods, either the volunteers who join up following a introduction by the researcher in the first 10 minutes before of each class in the community center or through advertisements that would call for volunteers for a weight-loss program that involves no medication for moderately overweight and obese patients. People with a record of alcohol dependence within the last one year would be disqualified.. Patients with psychiatric disorders which in the investigator’s judgment would interfere with the study were also barred. Patients who commenced a new drug therapy within 30 days of the randomization of the subjects of the study would also be disqualified. The study protocol was reviewed by the local institutional review board of the medical and ethical committee. My tutor said: Which institution My tutor said: Power calculative needed here gcan provide the words if you give me the expected or useful difference you are require eg/S.I Intervention 60 subjects divided into two random groups of 30 persons, control group (n = 30) manage obesity by self-help and study group manage obesity by weight management intervention meetings by every 2 weeks. As per the Social learning theory, study group is reinforced with positive feedback (from the subject’s peer group) to promote weight loss- given as a cognitive restructuring behavior modification plan in the meetings. Both groups would be provided with the same exercise and diet program followed by BHF and others in first week of research. Main Outcome Measures Weight change was the primary outcome measure. Secondary outcomes included waist and hip circumference, body mass index, blood pressure, body fat, height.       AIMS OF AND JUSTIFICATION FOR THE RESEARCH: Provide a brief description of the proposed research, a justification as to why this research should proceed and an explanation of any expected benefits to the community. State the aims and significance of the project. If appropriate state the specific hypothesis to be tested. Please provide full references for any work referred to. (No more than 700 words) The proposed study tries to compare the effect of diet and exercise for weight loss between self help group and structurally intervened group. With a number of commercial weight loss seen in the society, not much studies have been formulated to study its efficacy. This study aims to also analyse the role of positive reinforcement and psychological feeling on weight loss. This study would benefit the society by helping to scientifically find out the effective way of weight loss, thus tends to make the society healthy. Objective: There have been few randomised trails of commercial weight loss programs .The aim of this study is to compare the weight loss and the attendant advantages achieved and consistently maintained in a structured commercial weight loss program with the weight loss achieved and maintained through self-help and counselling. The main aim of this study is to find out the is there any difference in weight loss effect between two groups , self help and the weight loss program following group. My tutor said: (This is not an objective it is reported eqults)One group would check the weight periodically during the process (every 2 weeks) , with the instructions being refreshed often , with the participants being encouraged on achievements and peer acknowledgement would be provided and the control group at the end of the total time My tutor said: (correct English) :( the end of 8 week). My tutor said: (new future tense – inconsistent): This study would use six parameters to quantify obesity and measure would eventually its drop. The six parameters to be measured would be waist and hip circumference, blood pressure, BMI or Body Mass Index, weight and the levels of body fat. The study is planned to answer the following questions along with psychological assessment that would be graded in scales points of 1 to 10 (appendix 4). This study thus poises to answer two questions as My tutor said: This in consistency suggests you have not carefully checked all detentes. Which is more effective way to manage obesity – self help or to a structured and intervened group? My tutor said: correct English Is there a correlation between positive reinforcement provided by the overweight subject’s peer group and weight loss that could be seen from psychological analysis? Obesity is a worldwide problem and is a part of the symptom constellation of a variety of lifestyle afflictions like diabetes and cardiovascular disease. in addition obesity has been linked to mental health conditions ,such as depression or feelings of shame and low self steem , many people with obesity problem are discriminated against and targets of insults and other verbal abuse.(Hitz,2005)unfortunately, the result of some research showed that a male job applicant was rated more negatively when seen with an overweight female than with a normal weight female.(Hebl,2003)The NHS spend at least £500m a year on treating obesity (),which could also be costing the economy over £2bn a year.(DrReilly,1998). Thus reducing the prevalence of obesity has become an important public health priority worldwide.(AnnaTimperio,2004) The prevalence of obesity in England had tripled over the last 20 years and continues to rise more adult in England are now overweight and one in five in obese. Treatment of obesity is possible using a variety of approaches, including the Self help approach to lose weight. My tutor said: Repetitive It is important to understand the efficacy of these programs with respect to each other.It is important to quantify obesity and define the parameters, which will be examined during the study. Weight, Body Mass Index (BMI), Waist measure, and finally the levels of body fat are the parameters, which we shall use to quantify obesity. The mental aspect of wanting to lose weight to achieve a higher quality of life will also form a part of the study. Quality of life is an idea, which encompasses the physical, psychological and societal aspects of a person’s life. Obesity has wide ranging implications on all of them and its treatment will result in an improvement on the quality of life of the individual (Testa and Simonson 1996). FOR below PARAGERAF My tutor said: you do not report whethe there was signific different or just trends? Although commercial weight loss programs provide treatment to million of clients My tutor said:English??, their efficacy has not been evaluated in rigorous long term trial. The result of research in 2003 which compared self help weight loss with structured commercial between overweight and obese men(n=65) and women(n=358)body mass index 27-40 and aged 18 to 65 years showed the structured commercial weight loss program(My tutor said: depend above highlighted(structured commercial) : NOUN) provided modest weight loss but more than self help over a 2 years period.(Stanley,Heshka.2003).The program also makes efforts to change the total life style, including changes in diet, more exercise, and reduced consumption of alcohol.(Anders G,1981)The group support environment certain weight loss program may be more effective for women because they tend to like the idea of sharing success and failure stories more than man shares. (Michael smith, 2003) Other studies have also examined that, of 423 subjects( body mass -index of 27 to 40) in a multicenter , the result showed the commercial weight loss programs more likely to be effective for managing moderately overweight patients than brief counseling and self help.(Stanley H,2000)people who lose weight with the help of a commercial program are more likely to a keep more pounds off than if they lose weight without help, according to a multi center study conducted in part by the University of Kentucky to be published in the April 9 issue of the(My tutor said: the what???)(Lexington,Ky.2003) 1.3 RESEARCH APPROACH, METHODS FOR DATA COLLECTION AND ANALYSIS: Provide an outline of the proposed method, including details of data collection techniques, tasks participants will be asked to do, the estimated time commitment involved, and how data will be analysed. If the project includes any procedure which is beyond already established and accepted techniques please include a description of it. (No more than 500 words.) The study would divide the participants into two group as control – self help group and study – the intervened weight loss group . both the group would be given instruction about diet and exercise , with the study group would be met once in two week and weight loss would be analysed by measuring, waist circumference, BMI, etc. the control group would be met at the 8t week and the results would be compared statistically. After ascertaining the confirmation of a candidate’s eligibility after the initial screening test, they were allotted to one of the two groups. (Weight management program with positive reinforcement and self help without positive reinforcement) Randomization Procedure The participants are then randomly assigned for study and control group with 30 in each group. Methodology of the Study (My tutor said: back to past tense)This section will deal with the methods to be followed in the study for obesity management. (My tutor said: Yes, so the title says –don't waste words.)The patients assigned to the self-help method had 20 minute consultations with a researcher at week 0 (randomization week) and the week 8. During these consultations They would be given printed material available in the open domain sensitizing them to the diet and exercise program followed by BHF and others. Details of various open domain resources like weight loss web sites on the Internet, the telephone numbers of organizations offering free weight loss program. The study groups the plan, instruction and diet are given by the researcher and during the meetings the concept is refreshed and as a positive reinforcement, the weight losers are encouraged by the researcher and the peer group members. Collection of Data At the initial screening visit, all patients (My tutor said: back to past tense ) would be subjected to a medical history evaluation (form). Height was measured at baseline to the nearest centimeter without shoes. Weight was measured at all visits on a calibrated scale to the nearest 0.2 kg in street clothing without shoes. Tanita Analyser was used to quantify the body fat levels of the patients. The Tanita analyzer uses impedance analysis to quantify body fat. It is important to ensure the availability of all specialized monitoring equipment at all clinical sites to ensure uniform availability of data for subsequent statistical analysis. Waist and hip circumference was measured at week 0 and week 28. BMI was calculated from the recorded height and weight. BP was measured by digital pressure gauge and it is to be taken on 2,4,6, 8th week., Body fat, waist and hip measurement would be taken on 4th and 8th week as these parameters would not change on significantly in a weeks difference.???(My tutor said:?????????) Psychological Related Questions This is done to ascertain the part of the psychology in the study. To assess these open questions would be asked to the participants and rated from scale 0 to 10. Psychological questions would be taken on 4th and 8th week.(Appendix 4) Statistical Analysis . (My tutor said: NO, this is not a clinical setting) (Sheiner LB, Rubin DB 1995)]. ((My tutor said: the all above part should deleted, this is a report of another study) The results from the study could be statistically tested using the Independent((My tutor said: reported measures)t-test that would indicate the significant difference between the weight watcher and self learner group. (My tutor said: should deleted) Based on the ‘p’ value for the rate of wound healing at the 95% significance level of a one-tailed t-test .An independent t-test is selected as helps us to look at the difference between the two sets of means of both groups. SSPS version 9.0 statistics programme can also be used for the analysis of the results .The analysis of the data’s by this statistical method requires the calculation of mean, standard deviation and standard error mean. Then Levine’s test of equality variance may be employed for calculating the variance and significance respectively.( (Losh, S.C 2002). Thus the research project success is to complete and test the outlined hypothesis in regard to the significant difference between the weight watcher and self help group. 1.6 PLEASE EXPLAIN WHEN, HOW, WHERE, AND TO WHOM RESULTS WILL BE DISSEMINATED, INCLUDING WHETHER participants WILL be provided with any information ON the FINDINGS OR OUTCOMES of the project(My tutor said: where this the published eg,which jurnals plus your msc thesis) the results of the study would be published in the thsesis and in scientific journals. all the participants would be informed about the result of study individually through mail after the thesis is accepted. (My tutor said: Aims or objectives)The aim of the study is to evaluate the effectiveness of weight loss programs in different circumstances and also to analyse the various psychological thoughts that affect the weight loss. The study will require 8 weeks (2 months) as per its design. It is imperative to coordinate amongst the two community sites the various parameters outlined in the methodology of the study. As the list of parameters requiring coordination is large it is expected that a minimum of Two months will be required for coordination. After the study is completed the statistical analysis of data and compilation of results would be done using various statistical analysis techniques outlined above. It is expected that the analysis of the compiled data will take two months. The timeframes outlined above are guidelines and are subject to change as per the ground realities. (April to August) (My tutor said: methods, cant chart) Gantt chart Description 0week 1st wk 2nd wk 3rd wk 4th wk 5th wk 6th wk 7th wk 8th wk 9th wk Providing material and instruction Collecting data from study group Collecting data from study group Collecting data from study group Collecting data from study group and control group Statistical analysis The results will be submitted to University and can be useful for advanced research regarding obesity and vulnerability of diseases. (My tutor said: back 1 page for comment – you must specify) NUMBER, AGE RANGE AND SOURCE OF PARTICIPANTS Provide number, age range and source of participants. Please provide an explanation for your proposed sample size (including details of statistical power of the sample, where appropriate) and state any exclusion or inclusion criteria. A total of sixty obese or over weight women in the age group of 25 to 60 years would be the participants . they would be gathered from a weight loss program or through advertisement. Women with other physical ailment and alcoholics would be excluded. Participants: 60 participants overweight and obese women age 19 to 64, body mass index 25 -41 kg/m2. The eligibility criteria for women was fixed at a body mass index ranging from 25 to 41 kg/m2 and age ranging from 19 to 64 years. Women with various afflictions whose treatment involves weight loss were also considered. The patients were selected by two methods. The participants would be selected either the volunteers who join up following a introduction by the researcher in the first 10 minutes before of each class in the community center and secondly by advertisements that would call for volunteers for a weight-loss program with no medication for moderately overweight and obese patients. Initial screening involved would be an interview after which if found suitable, the candidates signed an informed consent form and have an information sheet about research and underwent preliminary medical checkups to determine suitability for the study. Written informed consent and medical history would be obtained from all participants. (My tutor said: future past same sentence!!!) 3.4 PLEASE EXPLAIN HOW THE POTENTIAL BENEFITS OF THE RESEARCH OUTWEIGH ANY RISKS TO PARTICIPANTS. Briefly describe the main benefits and contribution of the study. Include any immediate benefits to participants as well as the overall contribution to knowledge or practice 3.5 This study would definitely benefit the society by acting as a instrument for the conversion of society into a healthy one. It would provide the weight reducers about which would be effective way for the weight loss. The knowledge would further motivate them to get stuck to reducing their weight. As a immediate result the participant would understand and get motivated that they follow the correct path. (My tutor said: Introduction)Obesity is a worldwide problem and is a part of the symptom constellation of a variety of lifestyle afflictions like diabetes and cardiovascular disease. in addition obesity has been linked to mental health conditions ,such as depression or feelings of shame and low self steem , many people with obesity problem are discriminated against and targets of insults and other verbal abuse.(Hitz,2005). The aim of the study is to evaluate the effectiveness of weight loss programs in different circumstances and various psychological thoughts that affect the weight loss. (My tutor said: Aims) Weight change was the primary outcome measure. Secondary outcomes included waist and hip circumference, body mass index, blood pressure, body fat, height. The preliminary screening of patients is important so as to avoid subsequent complications. People who are overweight are more likely to have high blood pressure and high blood cholesterol levels and so have a greater risk of coronary heart disease. In general it could be observed that overweight or obese people are more likely to develop health problems. These problems include: Heart disease and hypertension, Diabetes, Cancer, Sleep apnea and. Arthritis. So it could be safely said that weight loss could tend to reduce the occurrence of listed severities. (My tutor said: English / intend) 3.5 ADVERSE / UNEXPECTED OUTCOMES Please describe what measures you have in place in the event of any unexpected outcomes or adverse effects to participants arising from involvement in the project. In case any adverse effects arise to the participant they would be immediately consulted to the prior arranged physician. . (My tutor said: this all below part should be deleted- state any possible lenefits –state any possible risks – evaluate these eg minimal- state any possible adverse outcames and how you would deal with it ) At the initial screening visit, all patients were subjected to a medical history evaluation (form). Height was measured at baseline to the nearest centimeter without shoes. Weight was measured at all visits on a calibrated scale to the nearest 0.2 kg in street clothing without shoes. Tanita Analyser was used to quantify the body fat levels of the patients. The Tanita analyzer uses impedance analysis to quantify body fatIt is important to ensure the availability of all specialized monitoring equipment at all clinical sites to ensure uniform availability of data for subsequent statistical analysis. Waist and hip circumference was measured at week 0 and week 28. BMI was calculated from the recorded height and weight. BP was measured by digital pressure gauge and it is to be taken on 2,4,6, 8th week., Body fat, waist and hip measurement would be taken on 4th and 8th week as these parameters would not change on weekly basis significantly Psychological Related Questions This is done to ascertain the part of the psychology in the study. To assess these open questions would be asked to the participants and rated from scale 0 to 10. Psychological questions would be taken on 4th and 8th week An intention-to-treat investigation was the model followed for data analysis. Wherever the data was missing, the missing data was replaced by the last relevant observation which was carried forward. This model was applied to the various measures of body weight and the Body Mass Index. Data about BP and BMI are to be taken on 2,4,6, 8th week and Psychological questions, Body fat, waist and hip measurement would be taken on 4th and 8th week as these parameters would not change on weekly basis significantly. (Sheiner LB, Rubin DB 1995)]. DEBRIEFING, SUPPORT AND/OR FEEDBACK TO PARTICIPANTS (as appropriate) What, if any, debriefing, support or feedback will participants receive following the study and when? Participants may need to talk about the experience of being involved in the study or about issues it has raised for them. Depending on risks to participants you may need to consider having additional support for participants during/after the study (e.g., external counseling). Further information on the aims of the research, their own performance and/or the results of the study may also be appropriate. The participant in study would be reinforced and counseled once in two weeks. As a additional reinforcement, external counseling for those participants who look doubtful would be provided. 60 subjects. (My tutor said: English) would be divided into two random groups of 30 personseach, with the control group (n = 30) managing obesity by self-help and study group managing obesity by weight management intervention meetings to be attented every 2 weeks. As per the Social learning theory, . (My tutor said: English) study group is reinforced with positive feedback (from the subject’s peer group) to promote weight loss- given as a cognitive restructuring behavior modification plan in the meetings. Both groups would be provided with the same exercise and diet program followed by BHF and others in first week of research. The study groups the plan, instruction and diet are given by the researcher and during the meetings the concept is refreshed and as a positive reinforcement, the weight losers are encouraged by the researcher and the peer group members. . (My tutor said: caps / method) the results of the study would be presented to the participants at the end of the study. (My tutor said: State the results will be presented to the participants at the end of the research) MONITORING Please explain how the researchers propose to monitor the conduct of the project (especially where several people are involved in recruiting or interviewing, administering procedures) to ensure that it conforms with the procedures set out in this application, the University’s Code of Practice and any guidelines published by their professional association. The researcher would personally monitor all the procedures and would follow the ethical guidelines and university published guidelines. (My tutor said: above part should be deleted) Read More