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Related Concept Videos

Group Design02:01

Group Design

The most basic experimental design involves two groups: the experimental group and the control group. The two groups are designed to be the same except for one difference— experimental manipulation. The experimental group gets the experimental manipulation—that is, the treatment or variable being tested—and the control group does not. Since experimental manipulation is the only difference between the experimental and control groups, we can be sure that any differences between the two are due to...
Study Designs in Epidemiology01:20

Study Designs in Epidemiology

Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and case-control studies.
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
Randomized Experiments01:13

Randomized Experiments

The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...

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Related Experiment Video

Updated: May 30, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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The Active for Life Year 5 (AFLY5) school based cluster randomised controlled trial: study protocol for a randomized

Debbie A Lawlor1, Russell Jago, Sian M Noble

  • 1MRC Centre for Causal Analyses in Translational Epidemiology, University of Bristol, UK. d.a.lawlor@bristol.ac.uk

Trials
|July 26, 2011
PubMed
Summary

This study evaluates a school-based intervention to boost physical activity, reduce sedentary behavior, and increase fruit and vegetable intake in children. The Active for Life Year 5 trial aims to improve child health outcomes through these lifestyle changes.

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Area of Science:

  • Public Health
  • Pediatric Health
  • Intervention Studies

Background:

  • Childhood physical inactivity, sedentary behavior, and low fruit/vegetable intake are prevalent and linked to poor health.
  • These lifestyle factors contribute to adverse health outcomes in children.
  • A school-based intervention aims to address these critical public health issues.

Purpose of the Study:

  • To describe the protocol for a cluster randomized controlled trial (RCT).
  • To evaluate a school-based intervention targeting physical activity, sedentary behavior, and diet in children.
  • To assess the public health effectiveness of the intervention.

Main Methods:

  • The Active for Life Year 5 (AFLY5) study is a cluster RCT involving Year 5 children (9-10 years old).
  • Schools are randomized to an intervention or control arm.
  • Primary outcomes include accelerometer-assessed physical activity and sedentary behavior, and questionnaire-assessed fruit/vegetable consumption, measured at baseline, immediate, and 12-month follow-ups.

Main Results:

  • Accelerometer and questionnaire data will be analyzed using random effects regression models.
  • Secondary outcomes include body mass index and overweight/obesity status.
  • Qualitative data from focus groups and interviews will explore intervention implementation and impact.

Conclusions:

  • The trial will provide crucial data on the effectiveness of a school-based intervention.
  • Findings will inform public health strategies for improving children's physical activity, sedentary behavior, and diet.
  • Results will contribute to understanding how to integrate health interventions into school settings.