Pre-registration in social psychology



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A project study on the difference between males and females in the response of dietary stress to depression

A. Introduction

Rationale (200) 

            The importance of diet in patients with depression affects the overall mood of patients with depression. Stress is a physiologic response to physical or emotional threats [6], but responses to stress are highly variable. Stress affects eating behavior, and diet can influence one’s physiologic responses to stress [7]. Diet is such a crucial component of mental well-being which has inspired the whole field of medicine known as nutritional psychiatry.  What people matter for each aspect of their health, particularly their mental health. Research studies support the relationship between the risk of depression and what one consumes based on gender.

            Consumption of carbohydrates has been found to relieve stress, and this has been regarded as part of the relationship for developing obesity for both genders.

Nonetheless, the relationship has also been observed in the opposite direction, with depressive and stress symptoms that result in unhealthy choices, with females being more depressed than males. Research studies on the impacts of depressive moods on food choice indicate that people who experience periods of depressive moods reported consuming food they usually avoid and that they consume these foods to reduce depressive moods. However, the link in kids, stress is related to being overweight, eating food to cope up, and bad eating habits. Poor eating habits are related to stress and depression among adolescents, both male and female. Depression increases the consumption of food in both genders and changes their food choices, especially from low fat- to high fat- foods. 

Hypothesis/Hypotheses (50):

            With an unhealthy diet, males will rise more depressed mood than females, females are more likely than men to have depression and a co-existing eating disorder. In the low-carbon water group, the level of depression in boys is not very different from that in females. In the high-carbon water group, the level of depression in females is higher than that in male

B. Method

• Design (100) Ideally, Design: CT. 1week- follow-up self-reporting

            Feasibility, multicenter, pragmatic RCT with blinded results assessment with a follow-up self-reporting. Participants will be randomized either to a 1-week dietary program plus normal care (intervention group) or normal- care alone (i.e. normal care group). The protocol for the trial design has already been published. 

            The target population will be men and women above 15 years of age who had a confirmed depressed moods diagnosis and reported having unhealthy eating habits. The trial will be designed explicitly to have increased applicability to people with depression, and it will use both exclusion criteria and inclusion criteria.

• Planned sample (100): G, porer,Muttule linear, posser-0.8, 40.05

            Processes will be tested to ensure that the trial feasibility provides actual practicalities indication for carrying out the intended trial. This will increase information on the full procedures testing that will be included in the trial process. Thus, more sample size computation, based on power considerations for detection of a between-group difference in the outcome, will not be suitable. A sample size of 50 participants would enable measurements of the retention rate with an accuracy of about ± 13%; for instance, if the 1-week rate of follow-up will be about eighty percent. Assuming the rate of follow-up at one week of eighty percent, and selecting 50 participants would give outcome data on at least twenty participants in each of the 2 selected groups, leading to reasonable approximates to be done of the variability in all the proposed results or outcomes. 

• Exclusion Criteria (50):

These participants will be excluded from the study

  • Had taken part in a management program (i.e. for depressed individuals) within the past month. 
  • Had comorbidities or illnesses that can influence their capacity to take part in the program safely or that the comorbidities can affect the trial (e.g. diabetes or epilepsy).
  • Had been selected to an interventional trial.

• Procedure 

            All the outcome assessments will be taken independently, at distinct research visits at health care. Before selection start, the researcher will meet with the research team members to achieve a consistent approach. An effort will be made to achieve blinded assessments, and participants will be requested not to discuss whether they are undertaking a dietary exercise program or going for a group session. We will choose a battery of measures carefully based on psychometric properties to ensure relevance and acceptability. The procedure will be done in one week and will entail leeds, 200, 10-pound voucher, RCT, two-blind, high-400g, and low-S02. One group will be given two carbon water groups, high-400g, low-S02 for one week and observations will be made. Another group will be a control group

C Analysis plan

Confirmatory analysis(100)

            All analyses will be carried out according to suitable reporting and analytical guidelines. For instance, primary analysis ( in summary statistics, not inferential/ formal analysis) will be carried out based on the intention-to-treat, in which participants will be analyzed in accordance to their allocated group, despite adherence to the guidelines or lack of completion or participation is assigned to the intervention group.

Since this will be a feasibility trial, comparisons of between-group will not be conducted. That is hypothesis testing of between-group will not be undertaken. C.I. will be at 0.95 when presented unless stated otherwise.

Expected pattern of results(50)

            The study confirms that men experience more stress than females in an unhealthy diet. Again, based on the analysis female are more likely to have co-existing eating disorders and depression than men. The level of stress in men is the same as that of females in the low-carbon water group. In addition, the level of depressed mood is higher in women than that in males, in a high-carbon group in a high-carbon water group.























Van’t Veer, A. E., & Giner-Sorolla, R. (2016). Pre-registration in social psychology—A discussion and suggested template. Journal of experimental social psychology67, 2-12.






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