Impact of long-term consumption of supplementary-meal drink on wellbeing of obese Indian females

Background: Formulated supplementary drinks may provide overweight consumers an easier way to consume the recommended dietary intake of macro- and micro-nutrients. There is lack of concluding evidence on long term consumption of such drinks on general wellbeing of obese Indian females. Research Hypothesis/Hypotheses: Null hypothesis: Wellbeing of females who ever consumed the drink is the same as those who consumed it over a month and those who consumed it for more than six months on a daily basis. Study design: A four-month double-blinded randomized controlled trial in India will be conducted from January 2018 where there will be a total of three randomly allocated groups of participants (control group: ever consumed drink in the past year but not in the current study; group 1: consume the drink daily for a month; group 2: consume the drink daily for a period of six months). Sampling technique: Gender-stratified sampling technique of all obese adults (aged 18-35 years old) who live in New Delhi, India. Adults with any allergies will be excluded. Data collection: Dietary intake will be collected using a validated 3-day dietary record. Height, weight and blood samples (5mL) will be collected at clinic visits using standardized stadiometer, weighing scales and qualified clinicians with good rater reliability (>0.85). All data will be collected on the first day of every month. Statistical analyses: Body mass index (BMI) will be calculated and its mean and standard deviation reported as the main descriptive statistics. Wellbeing of the participants will be compared using one-way ANOVA. The significance level will be set at 0.01. Ethics application: New Delhi Central Ethics Committee on Human Research; Curtin University Human Research Ethics Committee Limitations of the study: Not applicable. Significance of the study: Question 1 In Example 2, is the proposed sampling technique appropriate to answer the gap of knowledge and the research hypothesis? Please justify your answer of ‘Yes’ or ‘No'.( Yes/No (choose one and delete the other), I think the proposed sampling technique is/is not (choose one and delete the other) appropriate because ... (short response of 2-3 lines). Question 2 Suggest five things to improve the Example 2 draft synopsis.( I would improve the draft synopsis in Example 2 by: … (Dot points below)      

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