CLINICAL TRIAL

Self-Efficacy for Obesity

Recruiting · 18+ · All Sexes · Providence, RI

Miro-randomized Trial for Optimizing a JITAI to Reduce Dietary Lapses in Obesity Treatment

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About the trial for Obesity

Treatment Groups

This trial involves 6 different treatments. Self-Efficacy is the primary treatment being studied. Participants will be divided into 4 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Online Behavioral Obesity Treatment
BEHAVIORAL
+
Self-Regulation
BEHAVIORAL
Experimental Group 2
Online Behavioral Obesity Treatment
BEHAVIORAL
+
Motivation
BEHAVIORAL
Experimental Group 3
Online Behavioral Obesity Treatment
BEHAVIORAL
+
Self-Efficacy
BEHAVIORAL
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enhanced Education
2011
Completed Phase 3
~320
Self-Efficacy
2009
N/A
~1220
Motivation
2016
N/A
~1070

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age 18-70
Body mass index (BMI) between 25 and 50 kg/m-squared
Diagnosis of one or more cardiovascular disease risk factors (prediabetes, type 2 diabetes, hypercholesterolemia, or hypertension)
Able to walk 2 city blocks without stopping
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline, 3-months, 6-months
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline, 3-months, 6-months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, 3-months, 6-months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Self-Efficacy will improve 1 primary outcome, 4 secondary outcomes, and 22 other outcomes in patients with Obesity. Measurement will happen over the course of Daily for 2 weeks after each assessment period.

Objectively-measured Eating Rate
DAILY FOR 2 WEEKS AFTER EACH ASSESSMENT PERIOD
Wrist-based accelerometers will measure the rate of eating (seconds per bite).
DAILY FOR 2 WEEKS AFTER EACH ASSESSMENT PERIOD
Objectively-measured Estimated Caloric Intake
DAILY FOR 2 WEEKS AFTER EACH ASSESSMENT PERIOD
Wrist-based accelerometers will measure the number of bites taken during an eating episode, which can then be used to estimate caloric intake.
DAILY FOR 2 WEEKS AFTER EACH ASSESSMENT PERIOD
Objectively-measured Eating Duration
DAILY FOR 2 WEEKS AFTER EACH ASSESSMENT PERIOD
Wrist-based accelerometers will measure the length, in minutes, of eating episodes.
DAILY FOR 2 WEEKS AFTER EACH ASSESSMENT PERIOD
Height
ONCE AT BASELINE ASSESSMENT
Height will be measured to the nearest millimeter with a stadiometer at baseline, using standard procedures.
ONCE AT BASELINE ASSESSMENT
Objectively-measured Eating Frequency
DAILY FOR 2 WEEKS AFTER EACH ASSESSMENT PERIOD
Wrist-based accelerometers will measure how frequently a participant eats throughout their daily life
DAILY FOR 2 WEEKS AFTER EACH ASSESSMENT PERIOD
JITAI Tailoring Variable: Cravings
DAILY OVER 6 MONTHS
Cravings will be measured via ecological momentary assessment by asking if the participant is experiencing a craving in the moment (Yes/No).
DAILY OVER 6 MONTHS
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Who is running the study

Principal Investigator
S. G.
Stephanie Goldstein, Research Scientist
The Miriam Hospital

Patient Q & A Section

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

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

Over one quarter of the US population is overweight or obese. The probability of being overweight or obese is increasing. The chances of being overweight or obese, for men and women, are roughly 25% and 9% respectively. People who are overweight or obese are disproportionately black. Among people aged 25 and older in the US, the prevalence of overweight or obesity is 20.6%; among black adults, it is 30.6%.

Anonymous Patient Answer

What is obesity?

Obesity (defined by BMI) is prevalent in this US sample of hospitalized patients and is strongly associated with medical comorbidities such as hypertriglyceridaemia of varying severity.

Anonymous Patient Answer

What causes obesity?

The current consensus is that excess consumption of energy in the form of a large amount of food is the major cause. Many of the changes in the energy balance of an individual are caused by changes in the metabolism which vary between individuals. Some of these metabolic changes may be a result of changes in diet, although others are unrelated to changes in diet. The metabolic changes which could be a cause of obesity are insulin resistance, lipodystrophy, leptin resistance, and sympathetic nervous overactivity. The changes may be a result of the obesity itself, since there is an increase in the secretion of insulin and adipocyte lipolysis, and the changes could cause an increase in the amount of fat stored in adipose tissue.

Anonymous Patient Answer

What are the signs of obesity?

What are the signs of obesity? Obesity can give rise to many of the similar symptoms that other systemic diseases give rise to, such as fatty lumps, pain and swelling. It can also affect how your immune system functions and therefore lead to conditions such as infection and cancer.\n

Anonymous Patient Answer

What are common treatments for obesity?

Despite years of study and the growing number of treatments available, only two of the 21 drugs currently approved in the U.S. for obesity or weight loss are used to treat obesity.

Anonymous Patient Answer

Can obesity be cured?

Obesity can be improved by a restrictive diet and/or intense exercise but it cannot be completely reversed. However, improvements in physical fitness can help to achieve normal body weight and reduce the impact of obesity on health and quality of life.

Anonymous Patient Answer

What is self-efficacy?

Results from a recent paper indicate that individuals having the opportunity to participate in a rigorous fat control program with the goal of losing weight should be less likely to lose weight after 12 months than those in a non-treatment control condition.

Anonymous Patient Answer

What is the average age someone gets obesity?

If there were someone looking for the average age when someone gets obesity it would have to be at 42.4 for females and 47.5 for males. A person that was looking for the minimum average age when someone gets obesity would have to be at 30.7 for females and 33 years old for males. One thing that you can agree on is that the average age someone gets childhood obesity is 4, and the highest age when someone gets obesity is 69 years. The average age when someone gets obesity today is 28.7 for females and 32 for males. So the minimum and maximum ages when someone gets obesity is 18 years and 82 years.

Anonymous Patient Answer

Is self-efficacy typically used in combination with any other treatments?

Results from a recent paper of this review show that self-efficacy is often used as part of treatments for obesity but may be poorly measured. Self-efficacy has also always been treated in isolation but evidence for its benefits in obese people should be explored. Self-concept and self-awareness are likely to have an important influence over self-efficacy but need further investigation. Clinicians need to be aware of these factors to better use self efficacy for obese people in treatment.

Anonymous Patient Answer

Have there been any new discoveries for treating obesity?

In the years we’ve been researching obesity, there seems to be fewer discoveries in the treatment of obesity. But the number of discoveries in the basic science has increased considerably. We’ve learnt so much since the discovery of insulin, by Dr. Frederick Banting in 1922. We’ve learnt so much since that Nobel Prize in 1980 for insulin, by Dr. David Sinclair and other researchers of Dr. Frederick Banting’s lab. We’ve learnt so much since Dr. Robert R. Coleman’s research on leptin by Dr. Coleman and Dr. Svetlana Zabolotnaya.

Anonymous Patient Answer

Does obesity run in families?

It seems to arouse a large number of people that obesity runs in families. A survey that explores if the risk of obesity is increased in families is needed.

Anonymous Patient Answer

Who should consider clinical trials for obesity?

Clinicians should consider clinical trials for obesity. Data from a recent study of such studies have the potential to inform decision-making in regard to the use of weight loss surgery in the management of morbid obesity.

Anonymous Patient Answer
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