Rationale and design of the Clinic and Community Approaches to Healthy Weight Randomized Trial

Lauren Fiechtner1, Meghan Perkins2, Vincent Biggs3

  • 1Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA 02114, USA; Department of Gastroenterology and Nutrition, MassGeneral Hospital for Children, 175 Cambridge St., 5th floor, Boston, MA 02114, USA.

Insights

This study compared two pediatric weight management programs for low-income children. It aims to find the most effective approach for reducing childhood obesity in clinical or community settings.

Area of Science:

  • Pediatric Health
  • Obesity Research
  • Public Health Interventions

Background:

  • Childhood obesity is a growing concern, particularly among low-income populations.
  • Family-centered pediatric weight management programs show promise but require optimization for underserved communities.
  • There is a need for scalable interventions to address obesity in low-income children.

Purpose of the Study:

  • To compare the effectiveness of two distinct pediatric weight management programs.
  • To evaluate interventions delivered in clinical versus community settings.
  • To inform care strategies for millions of children with obesity covered by public insurance.

Main Methods:

  • A randomized trial comparing a clinic-based program (Federally Qualified Health Centers) with a community-based program (YMCAs).
  • Inclusion of children aged 6-12 years with a body mass index (BMI) at or above the 85th percentile.
  • One-year program duration with at least 30 contact hours, with outcomes measured at baseline, 6 months, and 1 year.

Main Results:

  • The primary outcome is the change in BMI (kg/m²) and percent change of the 95th percentile (%BMIp95) at 1 year.
  • Data collection includes baseline, 6-month, and 1-year follow-ups.
  • Comparative effectiveness of clinic-based versus community-based interventions will be analyzed.

Conclusions:

  • The study will determine the comparative effects of clinical and community-based interventions for childhood obesity.
  • Findings will guide the care of over 7 million children with obesity insured by Medicaid or the Children's Health Insurance Program.
  • This research contributes to developing effective and scalable solutions for pediatric weight management in vulnerable populations.
Abstract

Related Concept Videos

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...
10.9K
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...
5.1K
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

Body:Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to...
271
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,...
164
Statistical Software for Data Analysis and Clinical Trials01:12

Statistical Software for Data Analysis and Clinical Trials

Statistical software is pivotal in data analysis and clinical trials by providing tools to analyze data, draw conclusions, and make predictions. These software packages range from simple data management applications to complex analytical platforms, supporting various statistical tests, models, and simulation techniques. Their significance lies in their ability to handle vast amounts of data with precision and efficiency, enabling researchers to validate hypotheses, identify trends, and make...
1.6K
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...
10.8K