FBT+Variety for Obesity

Phase-Based Estimates
1
Effectiveness
1
Safety
Healthy Eating and Activity Lab, University of Tennessee, Knoxville, TN
Obesity+2 More
FBT+Variety - Behavioral
Eligibility
< 18
All Sexes
Eligible conditions
Obesity

Study Summary

This study is evaluating whether a limited variety of high energy dense foods may help reduce obesity in children.

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Eligible Conditions

  • Obesity
  • Pediatric Obesity
  • Obesity, Childhood

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether FBT+Variety will improve 2 primary outcomes and 10 secondary outcomes in patients with Obesity. Measurement will happen over the course of Change from 0 to 6, and 6 to 18 months.

Month 18
Compliance and process data
Month 18
Child Routines
Child and Adult Sleep Habits
Child and adult body mass index
Child and adult dietary Intake
Child and adult physical activity via wGT3X-BT
Child and adult salivary habituation
Child and adult waist circumference
Child eating pathology
Child percent overweight
Home Food Inventory
Meal planning, preparation, and grocery shopping

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

FBT (family-based behavioral treatment)
FBT+Variety

This trial requires 156 total participants across 2 different treatment groups

This trial involves 2 different treatments. FBT+Variety 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.

FBT+Variety
Behavioral
The FBT+Variety condition will receive FBT along with a limited variety prescription. In this prescription families will identify two RED foods, a dinner entree and snack food, and develop meal plans that reduce variety of RED foods by regularly consuming these foods and limiting consumption of other RED entrees and snack foods.
FBT (family-based behavioral treatment)
Behavioral
This condition will be prescribed the Traffic Light Diet (1000-1500 kcal/day, < 2 servings/day of RED [non-nutrient-dense, energy-dense] foods) and a > 60 min/day of MVPA prescription for children and > 30 min/day of MVPA for adults at least 5 days/week. FBT will receive a family-based, behavioral intervention to assist the targeted child and a participating adult caregiver with making changes in energy balance behaviors.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6, 12, and 18 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6, 12, and 18 months for reporting.

Who is running the study

Principal Investigator
H. R.
Hollie Raynor, Interim Assistant Dean of Research
The University of Tennessee, Knoxville

Closest Location

Healthy Eating and Activity Lab, University of Tennessee - Knoxville, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
One adult caregiver who is obese and willing to attend meetings is needed for a study on weight loss treatments. show original
for adults The 85th percentile for BMI for adults is around 30. show original
age between 8 and 12 years

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can obesity be cured?

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The answer has to be no. Weight loss achieved in the initial obese phase of life, i. e. childhood or adolescence, has no predictive value for long-term response to a programme of regular exercise and dieting. In obese adults, weight loss achieved at such intervals has no impact on subsequent weight gain. Exercise-induced weight reduction in youth is associated with a favourable pattern of weight change when maintained in adulthood. Obesity is a lifelong problem, and a number of long-term consequences have been associated with the early occurrence of obesity in childhood.

Unverified Answer

What are the signs of obesity?

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The body mass index is a simple and useful measurement that has been shown to be useful in predicting adverse health outcomes and therefore should be part of routine clinical practice.

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What is obesity?

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Obese people typically have five or more body mass indices within the overweight category. To a minority of people there may be body-image dissatisfaction and social effects, but few have the physiological or medical problems related to diabetes, coronary heart disease and a high body-fat percentage.

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What are common treatments for obesity?

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This analysis provides specific examples for overweight and obese people that are commonly used as treatment. Recent findings also suggest that a combination of many treatments is also likely to yield the most optimal lifestyle benefit for overweight or obese people.

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What causes obesity?

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Obesity can develop from childhood through many different causes. Factors such as the availability of fast foods, low-carbohydrate diet, physical inactivity, and insufficient exercise all contribute to an increased obesity rate. The risk of developing obesity can vary on an individual basis, but there are various factors to consider, such as gender and genetic predisposition. Obesity is a serious health issue, as it increases the risk of several other health issues, such as diabetes, stroke, heart disease, and cancer.

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

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About 27 million Americans are obese every year. The obesity rate in 2001 was 35.0%. This rate is consistent with an overall increase in obesity rates over the past decade.

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How serious can obesity be?

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Recent findings obesity was not a major risk factor with reference to peri-operative mortality. The complication rate was low and all complications were easily manageable.

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Does obesity run in families?

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The present study shows that parental obesity is no protective factor for obesity in children, and it also raises questions regarding how much parental obesity influences the children's risk of developing obesity. It appears that, contrary to what has been assumed up to now, there is no inherent relationship between parental obesity and the occurrence or progression of childhood obesity.

Unverified Answer

Is fbt+variety typically used in combination with any other treatments?

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Fbt + variety is frequently used in combination with any other treatments, with the exception of monotherapy for h. pylori. It has to be emphasized that we did not evaluate the safety of any one fibrinogen product. For this reason, it cannot be determined if fibrinogen is the key mediator in the treatment of h. pylori, but a synergistic effect between the fibrinogen system and the antibiotics used to treat the infection can be assumed.

Unverified Answer

Is fbt+variety safe for people?

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The data showed that people who consumed fruit and/or vegetables as a part of a nutrient-dense diet had an array of health benefits, such as reduced risk of obesity and cardiovascular disease and improved quality of life. Eating more vegetables and fruit is the simple, efficient path to weight loss.

Unverified Answer

What does fbt+variety usually treat?

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The patients with elevated levels of cholesterol, hyperglycemia, and obesity had an improvement in their lipid profile. Patients with elevated levels of apolipoprotein B and hyperglycemia presented with an improvement in their glycemic control.

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How does fbt+variety work?

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Results suggest there is no advantage to mixing the 2 products when using them at the same time; however, the effect of one of the products may be inhibited when the other product is used with the product.

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