RCT

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Contents 1 Title 2 Abstract 2.1 How participants were allocated to interventions 3 Introduction 3.1 Topic Significance 3.2 Literature review emphasizing literature lag 3.3 Review of literature pertaining to topic. 3.4 Specific aims of the study 4 Methods 4.1 Participants 4.2 Interventions 4.3 Outcomes 4.4 Sample Size 4.5 Randomization 4.6 Sequence Generation 4.7 Allocation Concealment 4.8 Implementation 4.9 Blinding 4.10 Statistical Methods 5 Results 5.1 Participant Flow 5.2 Recruitment 5.3 Baseline Data 5.4 Outcomes and Estimations 5.5 Ancillary Analyses 5.6 Adverse Events 6 Discussion

Title

Should have the word "randomized" to facilitate subsequent identification of the article in searches for systematic reviews or meta-analyses

• • Is routine preoperative ultrasonographic mapping for arteriovenous fistula creation necessary in patients with favorable physical examination findings? Results of a randomized controlled trial.
  • A randomized study of four cards designed to prevent problems during college students' 21st birthday celebrations.

Abstract

How participants were allocated to interventions

Use terms such as "random allocation", "randomized", or "randomly assigned

Introduction

Topic Significance

Should state the significance of the topic in a compeling manner to convince the reader that the article is worth reading in detail

• Obesity in children has reached epidemic proportions.
• In women undergoing assisted reproductive technology (ART), poor response to ovarian stimulation is a therapeutic challenge (7).
• Cutaneous Leishmaniasis (CL) is a worldwide disease that is endemic in 88 countries [1] . It is estimated that 1.5 million people suffer from CL annually and that more than 350 million are at risk of contracting the infection[2-4]. In America, 60,000 new cases of CL are reported annually [5], being endemic in 20 of its 22 countries and in 2 islands of the Caribbean [2]. Currently, CL has affected more than 500 U.S. Army soldiers serving in Iraq [6]. In the Andean region, the incidence of Leishmaniasis has been increasing dramatically over the last two decades; reaching more than 14,000 cases per year from 1996-98 [7].

Literature review emphasizing literature lag

Review of literature pertaining to topic.

Make broad statements backed up by literature rather than discussing specific papers. Show the lag or "hole" in current research on the topic, and how your research will attempt to fill this "hole"

• Ultimately energy imbalance is the reason for excessive weight gain, whether the main cause is genetic, endocrinal, or idiopathic.2 A contributory factor seems to be the consumption of carbonated drinks sweetened with sugar.3 These have a high glycaemic index and are energy dense. Children who drink one regular carbonated drink a day have an average 10% more total energy intake than non-consumers.4 In the United Kingdom more than 70% of adolescents consume carbonated drinks on a regular basis.
• Although school or family based programmes that promote physical activity, modification of dietary intake, and reduction of sedentary behaviours may help reduce obesity in children, few have been effective.6 Recently the United Kingdom based active programme prompting lifestyle in schools (APPLES) reported the effects of multiple interventions on obesity in children.7 The programme included teacher training, modification of school meals, action plans within the curriculum, changes to the tuck shop, physical education, and playground activities. Despite these initiatives there was only a modest increase in consumption of healthy foods such as vegetables without any change in obesity rates. In contrast, there is a paucity of studies on single factors considered to be important in obesity in children.
• In contrast, there is a paucity of studies on single factors considered to be important in obesity in children.

Specific aims of the study

Clearly specify the objectives of the study, which should be in line with the information lag outlined in the previous section

• We aimed to determine if a school based educational programme for reducing consumption of carbonated drinks could prevent excessive weight gain in children.
• The main objective was to discourage the consumption of "fizzy" drinks (sweetened and unsweetened) with positive affirmation of a balanced healthy diet. We thought the children would respond best to a simple, uncomplicated message so they were told that by decreasing sugar consumption they would improve overall wellbeing and that by reducing the consumption of diet carbonated drinks they would benefit dental health.

Methods

Participants

Eligibility criteria for participants and the settings and locations where the data were collected. This section can also include statement on IRB approval and informed consent.

• The Christchurch obesity prevention project in schools (CHOPPS) took place between August 2001 and October 2002 over one school year. The project was based in six junior schools in children aged 7 to 11 years.

Interventions

Precise details of the interventions intended for each group and how and when they were actually administered.

• A one hour session was assigned for each class each term. Teachers assisted in the sessions and were encouraged to reiterate the message in lessons. The initial session focused on the balance of good health and promotion of drinking water. The children tasted fruit to learn about the sweetness of natural products. In addition, each class was given a tooth immersed in a sweetened carbonated cola to assess its effect on dentition. The second and third sessions comprised a music competition; each class was given a copy of a song (Ditch the Fizz) and challenged to produce a song or a rap with a healthy message. The final session involved presentations of art and a classroom quiz based on a popular television game show. The children were also encouraged to access further information through the project´s website (www.b-dec.com).

Outcomes

Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors).

Sample Size

How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules.

• Sample size was estimated based on data from a pilot study conducted in the same geographical area.12 In the pilot, 54% (n = 149) of children gave consent, of whom 71% (n = 108) completed drink diaries. From this we predicted that we needed an average of 12 children in each class. The standard deviation of carbonated drink consumption in the pilot was 0.6 glasses (average glass size 250 ml) a day, therefore a study of this sample size (31 clusters with an average of 12 children) would have 90% power to detect average reductions each day of 0.9, 0.7, and 0.6 glasses over three days using intracluster correlations of 0.1, 0.05, 0.01, and 0.001.

Randomization

Sequence Generation

Method used to generate the random allocation sequence, including details of any restriction (e.g., blocking, stratification). Clusters were randomised according to a random number table

• The figure outlines the study design. Each of 29 classes (two of the 31 clusters were excluded because they were mixed age classes) was considered as a cluster. Fifteen were randomised to the intervention group and 14 to the control group. At the time of consent, parents and children were unaware of randomisation group. The average class size was 22 (SD 5) children (table 1). In total, 644 of 914 (70.5%) parents and children (320 girls) gave written consent.

Allocation Concealment

Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned.

Implementation

Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups.

Blinding

Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. If done, how the success of blinding was evaluated.

Statistical Methods

Statistical software Statistical methods used to compare groups for primary outcome(s) Methods for additional analyses, such as subgroup analyses and adjusted analyses. Significance level Data for interval scaled measurements for each cluster were derived by averaging all individual measurements for the children in the cluster, and dichotomous data were derived by calculating the proportion in the cluster. These were our summary measures, with clusters as the unit of analysis.

• All measures were normally distributed. We used the independent sample t test to establish significance between intervention and control clusters and the paired t test to establish the significance of changes within clusters.
• Intracluster correlation coefficients and 95% confidence intervals were calculated by using Searle´s method, with adjustment for variable cluster size.13

Results

Participant Flow

Flow of participants through each stage (a diagram is strongly recommended). For each group report the numbers of participants randomly assigned, receiving intended treatment, completing the study protocol, and analyzed for the primary outcome. Describe protocol deviations from study as planned, together with reasons.

Recruitment

Dates defining the periods of recruitment and follow-up

Baseline Data

Baseline demographic and clinical characteristics of each group.

• Both groups were similar at baseline for distributions of age, sex, consumption of sweetened carbonated drinks, and percentage overweight or obese (table 2).14

Number of participants (denominator) in each group included in each analysis and whether the analysis was by intention-to-treat". State the results in absolute numbers when feasible (e.g., 10/20, not 50%).

Outcomes and Estimations

For each primary and secondary outcome, present a summary of results for each group, the estimated effect size, and its precision (e.g., 95% confidence interval).

• Body mass index was measured in 602 (93.5%) children at six months and 574 (89.1%) at 12 months.
• Table 3 shows the body mass indices, z scores (SDS), and percentage of children above the 91% centile at baseline and 12 months and change in anthropometric measurements over 12 months. The intracluster correlation coefficient for body mass index was 0.01 (95% confidence interval -0.01 to 0.06). After 12 months there was no significant change in the difference in body mass index (mean difference 0.13, -0.08 to 0.34) or z score (0.04, -0.04 to 0.12). At 12 months the mean percentage of overweight and obese children increased in the control clusters by 7.5%, compared with a decrease in the intervention group of 0.2% (mean difference 7.7%, 2.2% to 13.1%; fig 2). Assessing and comparing prevalence between studies is influenced by the methods used to classify overweight children (table 4).
• Overall, 55.0% (338 of 615) of the children returned the first drink diary and 56.0% (321 of 574) returned the second; 36% (235) returned both. Body mass indices between those children who returned the diaries and those who did not were similar (17.3 (2.3) v 17.5 (2.4), respectively, P = 0.3 using the t test) Overall, 19.0% of the children who did or did not return diaries at baseline were overweight. Baseline consumption of carbonated drinks was similar between children who did or did not return diaries at 12 months (1.8 v 1.9 glasses, -0.7 to 0.3 glasses).
• The intracluster correlation for consumption of carbonated drinks was -0.009 (-0.03 to 0.05), suggesting independence between members of each cluster (table 5).13 At 12 months, consumption decreased in the intervention group compared with the control group (mean difference 0.7, 0.1 to 1.3). Water intake increased in both groups, but there was no difference between intervention and control clusters.

Ancillary Analyses

Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating those pre-specified and those exploratory.

Adverse Events

All important adverse events or side effects in each intervention group.

Discussion

Discussion writing template and guidance document