Regulation of Cues Enhanced for Overweight and Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UCSD Center for Healthy Eating and Activity Research (CHEAR), La Jolla, CA
Overweight and Obesity+1 More
Regulation of Cues Enhanced - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a behavioral weight loss program is more effective than a weight loss program that includes a prescription medication.

See full description

Eligible Conditions

  • Overweight and Obesity

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Regulation of Cues Enhanced will improve 1 primary outcome and 6 secondary outcomes in patients with Overweight and Obesity. Measurement will happen over the course of Change from baseline at an average of 6 months, 12 months, and 18 months.

Month 18
Change in Caloric Intake As Measured by the DHQ III
Change in Eating Cognitions As Measured by the FCQ-T-reduced
Change in Food Responsiveness As Measured by the FR Scale of the AEBQ
Change in Inhibition As Measured by the Stop Signal Task
Change in Restriction As Measured by the TFEQ
Change in Satiety Responsiveness As Measured by the SR Scale of the AEBQ
Month 18
Change in Body Mass Index

Trial Safety

Trial Design

3 Treatment Groups

Nutrition, Stress Management, and Social Support
1 of 3
Behavioral Weight Loss
1 of 3
Regulation of Cues Enhanced Treatment
1 of 3
Active Control
Experimental Treatment

This trial requires 300 total participants across 3 different treatment groups

This trial involves 3 different treatments. Regulation Of Cues Enhanced 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.

Regulation of Cues Enhanced Treatment
Behavioral
The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning, and it will be combined with aspects of BWL to capitalize on the strengths of both treatments.
Nutrition, Stress Management, and Social Support
Behavioral
Nutrition Education, Stress Management and Social Support will be covered. Mindfulness will be practiced in every session.
Behavioral Weight Loss
Behavioral
The BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline at an average of 6 months, 9 months, 12 months, 15 months, and 18 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from baseline at an average of 6 months, 9 months, 12 months, 15 months, and 18 months for reporting.

Who is running the study

Principal Investigator
K. B.
Prof. Kerri Boutelle, Kerri Boutelle, Ph.D., Professor, Herbert Wertheim School of Public Health and Longevity Science and School of Medicine Departments of Pediatrics and Psychiatry
University of California, San Diego

Closest Location

UCSD Center for Healthy Eating and Activity Research (CHEAR) - La Jolla, CA

Eligibility Criteria

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

Mark “yes” if the following statements are true for you:
is classified as overweight; BMI greater than 45kg/m^2 is classified as obese show original
able to take part in assessments and treatment sessions, either in person or through zoom meetings that are password protected. show original
able to provide data through questionnaires
A food responsiveness is a measure of how reactive someone is to the foods they eat show original
(EMA) The person has a smart phone that they can use to complete Ecological Momentary Assessments (EMA). show original
able to read English at a 5th grade reading level

Patient Q&A Section

Can overweight be cured?

"All treatments, including conventional treatment and a very intensively managed intensive intervention, can improve the prognosis of overweight children. However, it is impossible to prevent all cases of overweight but it is possible to prevent its consequences. As overweight has been correlated with a number of physiological and psychological consequences, these can be solved and/or prevented by a structured lifestyle program." - Anonymous Online Contributor

Unverified Answer

What causes overweight?

"The development of overweight, defined as an BMI greater than 25 kg / m 2, can be prevented by a healthy diet, regular exercise and weight control." - Anonymous Online Contributor

Unverified Answer

What is overweight?

"In addition to body Mass Index (BMI) and age, other factors can be considered in a medical assessment: adiposity of the whole body, abdominal obesity, and abdominal circumference." - Anonymous Online Contributor

Unverified Answer

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

"This article addresses the question of how often, in what numbers, Americans are at risk for developing either central or peripheral factors for obesity. The data are based on an extensive search through various medical and scientific databases, including reports by the National Health Study, National Health and Nutrition Examination Survey (NHS-EN)." - Anonymous Online Contributor

Unverified Answer

What are the signs of overweight?

"Obesity is a risk factor for many chronic diseases and the signs of overweight include a small fluctuating weight, lack of exercise, low energy levels and an increased rate of heart disease and diabetes mellitus." - Anonymous Online Contributor

Unverified Answer

What are common treatments for overweight?

"For the management of obesity in a primary care setting, the best practice has been for obesity to be treated through diet alone. However, studies suggest that obesity alone is only partially responsible for the other risks of overweight-related health conditions, as well as of cardiovascular disease. There is no doubt that regular exercise reduces other health risks; however, the evidence is weak on exercise's benefit in the prevention of obesity." - Anonymous Online Contributor

Unverified Answer

Has regulation of cues enhanced proven to be more effective than a placebo?

"Results from a recent paper did not show a significant difference between the cue and placebo groups in the sense of self-reported weight change. This could be due to the fact that the control condition was very low intensity in terms of exercise level; moreover, the study was poorly powered to show such subtle changes. Thus, this effect is at best a probable effect. However, in terms of actual weight change, a positive effect to enhancing cues is found." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving regulation of cues enhanced?

"In a recent study, findings of this preliminary study indicate that when a cue is paired at a specific level of arousal with a desired stimulus, it may be possible to limit the effects of the cue for a short amount of time. Further investigation is also needed. Some possibilities are explored for maximizing effectiveness at the time of cue-dependent cue regulation in order to improve the chances of cue-dependent cue regulation maintaining effectiveness." - Anonymous Online Contributor

Unverified Answer

What is the latest research for overweight?

"The conclusions regarding BMI remain remarkably similar from many scientific studies published in recent years, with small but consistent methodological and substantive effects of socioeconomic factors on the association between overweight and metabolic risk. Increasingly, there is an indication that high socio-economic inequality may contribute to a persistent association between overweight and metabolic risk. Recent findings are in line with the 'health equity hypothesis' and highlight the need for continued scientific efforts to understand the causes and contextualising of these relationships, particularly with respect to low SES groups." - Anonymous Online Contributor

Unverified Answer

How does regulation of cues enhanced work?

"In a recent study, findings from this study do not indicate that eating regulation is better than unrestricted eating. Interestingly, subjects in the regulated eating condition reported more cravings than those who were unrestricted; however, these cravings were not associated with eating behavior, so it is hard to say if cravings are a cause or a result of an eating disorder." - Anonymous Online Contributor

Unverified Answer

Does overweight run in families?

"Family environment was more important than genetic predisposition when assessing risk factors for overweight and obesity. Overweight should be treated as a family problem and preventive strategies should be tailored tailored to individuals' risk-factor profile regardless of underlying genetic predisposition." - 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.
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