ADAPT+ for Obesity

1
Effectiveness
1
Safety
Hispanic Services Council, Tampa, FL
Obesity+1 More
ADAPT+ - Behavioral
Eligibility
< 18
All Sexes
Eligible conditions
Obesity

Study Summary

This study is evaluating whether a mindfulness approach may help improve obesity treatment for children and their parents.

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Eligible Conditions

  • Obesity
  • Pediatric Obesity

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether ADAPT+ will improve 4 primary outcomes and 10 secondary outcomes in patients with Obesity. Measurement will happen over the course of 8 weeks after baseline.

8 weeks after baseline
Acceptability
Feasibility - Accrual Rates
Feasibility - Number of Sessions Completed
Feasibility - Physical Activity Goals
Through study completion, at study initiation, two months, three months, and five months
Child BMI z score
Child Food and PA Questionnaire
Child Step count
Child Waist-to-Hip Ratio
Dietary Habits
Mindfulness Attention Awareness Scale (MAAS)
Parent BMI
Parent Step Count
Parent Waist-to-Hip Ratio
Perceived Stress Scale (PSS)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Enhanced Usual Care (EUC)
Feasibility and acceptability of ADAPT+

This trial requires 108 total participants across 2 different treatment groups

This trial involves 2 different treatments. ADAPT+ 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.

Feasibility and acceptability of ADAPT+
Behavioral
ADAPT+ is a family-based obesity intervention for high-risk Latino youth and their parents living in rural communities that incorporates culture-specific components and mindfulness-based approaches to promote adaptive health behaviors in a high-risk and underserved population.
Enhanced Usual Care (EUC)
Behavioral
Enhanced Usual Care (EUC) provides publicly available material in both English and Spanish on the role of diet and exercise in pediatric obesity in a one-time information session.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, at study initiation, two months, three months, and five months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, at study initiation, two months, three months, and five months for reporting.

Closest Location

Hispanic Services Council - Tampa, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Child with a BMI %ile of 85 or higher.
The target parent is at least 18 years old, is the main meal preparer, speaks and reads Spanish at a minimum of a 4th grade reading level (able to follow basic instructions in Spanish), and able to perform simple physical exercises.

Patient Q&A Section

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

What are the signs of obesity?

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Obesity, defined as an excess of body weight relative to body surface area, can be present for a number of reasons, including insulin resistance and genetic susceptibility. However, many individuals who are of normal weight are also insulin resistant, which suggests that there are additional signs of obesity, in addition to the presence of excess fat. The presence of any of these signs, including excess subcutaneous fat, may constitute a clinical diagnosis of obesity. Further investigation, in the form of a large scale randomized trial, would be required to confirm the absence of obesity as a diagnosis. Results from a recent paper, obesity appeared to be associated with an increased incidence of certain cardiovascular diseases, but no conclusive evidence of any other signs of (or diseases of) obesity.

Unverified Answer

Can obesity be cured?

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Results from a recent clinical trial obtained in our study support the existence of a multifactorial etiology of obesity. Effective and targeted lifestyle modification and treatment for obesity can reduce the negative consequences of obesity in health-related fields.

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What causes obesity?

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A variety of influences including biological (e.g. genetic and environmental) predisposition, and behavior (e.g. energy intake and physical activity). Obesity is also influenced by social (e.g. economic environment and peer influence) and environmental factors.

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What is obesity?

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Obesity is a major risk factor for several chronic diseases, including Type 2 diabetes and coronary artery disease. It is estimated that by 2030, 37% of the US population will be obese. Obesity is also considered a modifiable risk indicator for several cancers.

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What are common treatments for obesity?

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Most patients with obesity are diagnosed at weight-loss clinics but continue to lose the weight following the diagnosis and often revert. As the prevalence of obesity continues to increase, there are growing demands on the obesity treatment market that may prompt new practices for the treatment of chronic conditions associated with obesity.

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

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Approximately 85% of men and 65% of women in the U.S. exceed the National Heart, Lung, and Blood Institute definition of overweight as well as the World Health Organization definition of obesity.

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What is the primary cause of obesity?

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Recent findings suggests there are multiple reasons that contribute to obesity and that each reason should be addressed. It also demonstrates the need to address the factors of social pressure, diet, and work stress that can precipitate or worsen the problem of obesity.

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Have there been any new discoveries for treating obesity?

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Currently, there isn’t any new treatment for obesity yet. However, there are some new discoveries of why overweight people are still obese, because obesity is usually due to both genetic factors and environmental factors. There are four main reasons: the metabolism of fat in the body is not as efficient as it needs to be; there's not enough energy to burn fat; there's not sufficient insulin to regulate fat uptake (the fat cells do not respond as well to insulin, which makes energy not available); and the brain and adipose tissue do not regulate weight appropriately.

Unverified Answer

What is the average age someone gets obesity?

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There is an association between prevalence and age. Obesity is a global epidemic and the prevalence of obesity is increasing in all parts of the world.

Unverified Answer

Have there been other clinical trials involving adapt+?

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This observational study provides preliminary evidence for both long-term weight loss and reduction in cardiovascular risk factors in a subgroup of people receiving adjuvant treatments during early-onset type 2 diabetes. As well as a reduction in the proportion of people remaining overweight and obese at 7 or 12-months follow-up, this study also has important clinical and public health implications. These results, obtained using a clinical trial design relying on treatment assignment rather than a naturalistic study, are strongly suggestive of this practice, given that it is not yet established clinically how long the long term effects of treatment to persist.

Unverified Answer

Does adapt+ improve quality of life for those with obesity?

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Findings of this study suggest a positive relationship between adaptive behavior and HRQOL improvement. Future research with larger samples is needed to confirm these results.

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Who should consider clinical trials for obesity?

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Clinicians have the opportunity for research that leads to improved treatments, which in the long run can potentially improve the care of their patients, especially those who are obese and have a great interest in the disease, because they have so much to lose or gain.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Obesity by sharing your contact details with the study coordinator.