Prevention Plus for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Healthy Eating and Activity Laboratory, Knoxville, TN
Obesity+2 More
Prevention Plus - Behavioral
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a program that teaches families about healthy eating and activity can improve fruit and vegetable intake.

See full description

Eligible Conditions

  • Obesity
  • Obesity, Childhood

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Prevention Plus will improve 5 primary outcomes and 7 secondary outcomes in patients with Obesity. Measurement will happen over the course of Baseline only.

Baseline only
Demographics
Month 6
Anthropometrics
Beverage Intake
Dietary Intake of Fruits and Vegetables
Food Purchasing and Household Food Availability
Food Security
Household Information
Month 6
Intervention Session Completion
Project Reach, participants who are eligible to participate in this study, but decline to participate in the study
Project Reach, the number of participants who participate in the study
Project Reach, total number of participants/patients who meet eligibility criteria
Voucher Redemption

Trial Safety

Trial Design

1 Treatment Group

Prevention Plus
1 of 1
Experimental Treatment

This trial requires 30 total participants across 1 different treatment group

This trial involves a single treatment. Prevention Plus is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Prevention Plus
Behavioral
Child's energy balance behavioral goals will be to consume < 3 sugar-sweetened beverages (e.g., regular carbonated soft drinks, sports drinks, lemonades, ice teas, flavored milk, juice drinks < 100% juice, and punches) servings /wk, ≥1 1 2 cups/day of whole vegetables and ≥ 1 cup/day of whole fruit, engage in ≥ 60 minutes/day of moderate- to vigorous-intensity physical activity, and reduce TV viewing to < 2 hours/day. The caregiver's energy balance behavioral goals will be to consume < 3 sugar-sweetened beverage servings/wk, ≥ 2 1 2 cups/day of whole vegetables and ≥ 1 1 2 cups/day of whole fruit, engage in ≥ 150 minutes of moderate- to vigorous-intensity physical activity per week and reduce TV viewing to < 10 hours/wk.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, an average of 6 months for reporting.

Who is running the study

Principal Investigator
H. R.
Hollie Raynor, Associate Dean of Research for the College of Education, Health, and Human Sciences
The University of Tennessee, Knoxville

Closest Location

Healthy Eating and Activity Laboratory - Knoxville, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients at the CHS Knox County Pediatric Clinic
Child age between 4 to 10 years old
Child BMI > 85 percentile
Child must have an adult caregiver (> 18 years) living in the household and be willing to participate in the program
Adult caregivers need to be able to read and speak English
Adult caregivers must be willing to shop for fresh fruits and vegetables at the Western Ave Food City Store (1950 Western Ave., Knoxville, TN, 37921)

Patient Q&A Section

What is obesity, childhood?

"Obesity is a common health problem with adverse consequences and has the potential to undermine the health and well-being of an individual. Childhood obesity is a major public health challenge because it is associated with many health problems including obesity associated cardiovascular diseases and cancers later in life." - Anonymous Online Contributor

Unverified Answer

What are the signs of obesity, childhood?

"Factors that contribute to the onset of obesity in children include the amount of fat being consumed, the number eating at the moment and the way they eat this food. Eating habits are not static and can be changed during childhood by engaging in exercise and eating healthy meals.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for obesity, childhood?

"The main treatments for obesity and childhood obesity include diet and exercise advice and surgery. There is no effective treatment for obesity except for obesity in the elderly. The obesity treatment should be focused on the specific patient to prevent the side effect of overweight and obesity and to avoid future medical problems and risk for diabetes or heart disease in the future." - Anonymous Online Contributor

Unverified Answer

How many people get obesity, childhood a year in the United States?

"Approximately 70 million children in the US are currently obese or overweight. Obesity is often associated with many chronic health problems. Preventing obesity in children and young adults is a major public health priority in the United States." - Anonymous Online Contributor

Unverified Answer

Can obesity, childhood be cured?

"An integrated obesity treatment can be designed by a multidisciplinary team including paediatricians in an environment where the primary goal is to assist weight loss, rather than to promote weight regain. In this environment, individuals will see a continuous improvement in their health, psychological and social well-being." - Anonymous Online Contributor

Unverified Answer

What causes obesity, childhood?

"Different factors affect the development of obesity. Childhood obesity is strongly linked to the consumption of unhealthy food. As well as genetics, diet has a role in the development of obesity." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for obesity, childhood?

"Although many research studies have already been conducted in pediatric samples, this paper is the first study regarding generalization of the child and adolescent samples, by examining age groups 5 years older than or younger than 10 years old. Data suggest that only obese adolescents (> or =95th percentile body mass index) should be considered for participation in research. Clinicians, researchers, healthcare professionals, and policy makers are urged to consider incorporating research in the pediatric obesity clinical setting to make healthier choices for the pediatric patients." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in prevention plus for therapeutic use?

"Obesity is one of the main risks of morbidity and mortality in the world. It is related not only to the development of non-communicable diseases, but also to cardiovascular diseases, diabetes, and cancers. Obesogenic diet, which is also known as the Western diet, is a key factor in promoting obesity. In order to combat obesity, a multifaceted policy should have a good strategy in which different types of interventions are made in which the objectives of the whole policy should be well known. In addition to the use of interventions on the individual level, strategies should also focus on the workplace and on our everyday life." - Anonymous Online Contributor

Unverified Answer

Is prevention plus safe for people?

"Results from a recent clinical trial of our study show the importance of screening for and educating the public around the problem of obesity and diet. As our study highlights the need to empower dieting practices to address obesity, this may be of important relevance of people presenting with NOD." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of prevention plus?

"The addition of vitamins to some of the prevention fad diets has been popularly proposed as a way to reduce some of the side effects of dieting. The current study is the largest prospective observational study to date investigating safety and efficacy of this supplement. In a recent study, findings indicate that this treatment may not provide an additional benefit over lifestyle modification alone in terms of weight loss, reduction in waist circumference or serum lipids." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets obesity, childhood?

"[The mean age of obesity development is 10.9 years in the United States.]<br>[There is evidence that obesity in childhood is increasing at an alarming rate in both the United States and Europe.]<br>[With increasing obesity, the effects of unhealthy weight gain continue to increase in health and mortality due to obesity. <br><br>[Obesity can influence many health issues that are associated with health and quality of life in children.<br>[The impact that obesity has on the healthcare system and health outcomes is a matter of contention in the healthcare system. Over 1.75 million Americans were newly diagnosed with obesity in 2004!]<br><br> (http://www.healthcarenation." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving prevention plus?

"There has been a large body of clinical research relating to obesity in childhood. There is a need for trials to assess whether lifestyle interventions could be used as part of a multi-component programme to reduce obesity rates in infants, toddlers and children. Clinicians may find clinical trials available by searching the NHS Research Connect website at http://researchconnect.nhs." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Obesity by sharing your contact details with the study coordinator.