CLINICAL TRIAL

Message Choice (No) for Obesity

High Risk
Waitlist Available · 18 - 65 · All Sexes · Chapel Hill, NC

NCT04922216

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About the trial for Obesity

Treatment Groups

This trial involves 32 different treatments. Message Choice (No) is the primary treatment being studied. Participants will be divided into 32 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Adaptive Activity Goals (Weekly)
BEHAVIORAL
+
Standard Diet Monitoring
BEHAVIORAL
+
Message Choice (No)
BEHAVIORAL
+
Message Decision Rules (Standard)
BEHAVIORAL
+
Core
BEHAVIORAL
+
Message Decision Points (Adaptive)
BEHAVIORAL
Experimental Group 2
Adaptive Activity Goals (Weekly)
BEHAVIORAL
+
Standard Diet Monitoring
BEHAVIORAL
+
Message Decision Rules (Standard)
BEHAVIORAL
+
Core
BEHAVIORAL
+
Message Decision Points (Adaptive)
BEHAVIORAL
+
Message Choice (Yes)
BEHAVIORAL
Experimental Group 3
Adaptive Activity Goals (Weekly)
BEHAVIORAL
+
Standard Diet Monitoring
BEHAVIORAL
+
Message Choice (No)
BEHAVIORAL
+
Core
BEHAVIORAL
+
Message Decision Points (Adaptive)
BEHAVIORAL
+
Message Decision Rules (Adaptive)
BEHAVIORAL
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Core
2017
Completed Early Phase 1
~1180

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
willing to be randomized to any levels of the factors
Not following the American College of Sports Medicine's recommendation of 150 minutes/week of moderate-to-vigorous intensity activity. show original
The body mass index (BMI) range between 25 and 40 kg/m^2 is considered to be overweight. show original
English-speaking and writing
If you want to be able to use your smartphone to its fullest potential, you'll need to have a data and text messaging plan show original
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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 Message Choice (No) will improve 13 secondary outcomes in patients with Obesity. Measurement will happen over the course of Baseline, 3 months.

Weight
BASELINE, 3 MONTHS
Absolute weight change from baseline to 3 months. Weight will be objectively measured on a digital scale in the participant's home.
BASELINE, 3 MONTHS
Physical activity self-monitoring adherence
BASELINE TO 6 MONTHS (DAILY)
Number of days of physical activity tracking over the 6 month period as measured by Fitbit tracker wear.
BASELINE TO 6 MONTHS (DAILY)
Weighing adherence
BASELINE TO 6 MONTHS (DAILY)
Number of days of self-weighing over the 6 month period.
BASELINE TO 6 MONTHS (DAILY)
Diet self-monitoring adherence
BASELINE TO 6 MONTHS (DAILY)
Number of days of complete dietary tracking summed over the 6-month study period.
BASELINE TO 6 MONTHS (DAILY)
Achievement of 5% weight loss
BASELINE TO 6 MONTHS
Percent change in body weight will be calculated (6 month weight - baseline weight/100) and determined to be at or above 5% indicating a clinically significant change.
BASELINE TO 6 MONTHS
Diet
BASELINE, 6 MONTHS
Change in daily caloric intake from baseline to 3 and 6 months as measured using the self-administered National Cancer Institute's Automated Self- Administered 24-hour Recall (ASA-24), a 24-hour recall that is self-administered on a week day and a weekend day at each timepoint.
BASELINE, 6 MONTHS
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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 is the average age someone gets obesity?

Obesity is associated almost exclusively with age ≥ 50 years. As a result, obesity tends to be less of a public health problem in older adults compared with younger adults.

Anonymous Patient Answer

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

Over 32 million Americans are obese as of 2013, up from 30 million in 2007. Over a third of American adults aged ≥45 are overweight on the 2007-2013 estimates. In the first decade of the 21st century, obesity has risen faster than previously thought.

Anonymous Patient Answer

What is obesity?

Obesity is a serious public-health issue in the United States. The causes of obesity are complex and often unpredictable. Preventing and treating obesity requires the coordinated efforts of many health professionals, health educators, policy makers, and the general public to effectively communicate information about the risks and benefits of lifestyle changes.

Anonymous Patient Answer

What are common treatments for obesity?

There are a variety of treatments for obesity. These include Diet, Behaviour Therapy, and Physical Activity. Weight loss is common among those who had a BMI ≥ 40 kg/m2. These groups may include those obese at an early age. At present there is no evidence that bariatric surgery is safe over the long term. These measures alone do not improve life expectancy.

Anonymous Patient Answer

Can obesity be cured?

There is the belief that obesity can be cured that is not supported by scientific evidence. Although there are many causes of obesity-related health risks, only a subset of those could be amenable to cure as opposed to a prevention strategy. There appears to be a discrepancy between the belief that obesity can be cured and the lack of progress. There is also the reality that patients with obesity-related morbidities will never need to lose weight for their health conditions to improve. Therefore, the belief that the obese can lose weight to improve their health is unrealistic. One of the reasons that is so difficult to change is that obesity is so socially unacceptable.

Anonymous Patient Answer

What causes obesity?

There are many possible causes of obesity. Reduced physical activity, changes in brain function which affect neural systems involved in decision making, altered autonomic and hormonal nervous system functions, and inadequate energy intake are all suspected contributors. The precise cause of obesity is still unclear. Research is underway to investigate a fuller understanding of obesity.\n

Anonymous Patient Answer

What are the signs of obesity?

Obesity increases the risk of developing high blood cholesterol, diabetes mellitus and coronary heart disease. In contrast to BMI as a surrogate marker for obesity, waist circumference appears a more specific screening tool for cardiovascular risk assessment.

Anonymous Patient Answer

What is message choice (no)?

Message choice has an impact on the message content that patients receive, which is important for patients who want to gain the information necessary to make informed decisions about their weight management plan. Patients who receive weight gain information and counseling as well as recommendations about dieting choices may decide that dieting is a more appropriate strategy to reduce their BMI.

Anonymous Patient Answer

Have there been any new discoveries for treating obesity?

A significant number of trials have concluded that a drug or other form of therapy has no significant effect on body weight. However, several medications approved by the Food and Drug Administration are available to treat obesity, such as orlistat (Pantobella), sibutramine (Meridia), phentermine (Adipex), and sibutramine (Meridia).

Anonymous Patient Answer

Have there been other clinical trials involving message choice (no)?

This review supports and builds on previous reviews on MMS. However, the limited sample in this review means it cannot be concluded whether or not a MMS is more effective in a particular population.

Anonymous Patient Answer

What is the primary cause of obesity?

Eating more than usual is a major factor in causing obesity, but factors beyond overeating are probably equally important. One study concluded that ‘obesity is largely determined by the relative contribution of calories obtained from solid foods and from fluids.’ Other studies suggest that ‘fiber’ is an extra ingredient, something found in solid foods that increases feeling full and therefore can be seen as causing obesity.

Anonymous Patient Answer

Is message choice (no) safe for people?

Findings from a recent study of this study suggest that a 'no-smoking' message, as opposed to a positive message that involves health advice such as stopping smoking, may be the more effective anti-smoking message for people.

Anonymous Patient Answer
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