CLINICAL TRIAL

Survey for Weight Gain

Waitlist Available · 18+ · All Sexes · Winston-Salem, NC

This study is evaluating whether an app for smartphones can help decrease interdialytic weight gains in hemodialysis patients.

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About the trial for Weight Gain

Treatment Groups

This trial involves 2 different treatments. Survey 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Fluid intake app
OTHER
Survey
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective and having given written (dated and signed) informed consent form to take part in the study.
Adult chronic hemodialysis patients who are at least 18 years of age
Average interdialytic fluid gains of less than 4% of body weight for both weekdays and weekends for a 30 day period
Access to a smartphone for use of the app and comfort with using apps on a regular basis
Access to a smartphone running under either iOS or Android operating systems
Sufficient knowledge and understanding of the English language to use the application available only in English (US) language
Mental capacity to use and understand the fluid management app
Willingness to share intake data collected with the research team
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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: 1 month
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 month.
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 Survey will improve 2 primary outcomes and 5 secondary outcomes in patients with Weight Gain. Measurement will happen over the course of 1 month.

Amount of fluid consumed
1 MONTH
The fluid consumed as recorded by use of the app for each interdialytic period. The association between the interdialytic weight gain and the fluid consumed will be assessed by a repeated measures analysis of variance with an unstructured covariance matrix.
Number of days that the app was used by dialysis or non-dialysis days
1 MONTH
Differences in app use by specific days of the week, including dialysis and non-dialysis days. This is a sub analysis using dialysis versus non-dialysis days.
Number of patients who experienced a 50% increase in fluid intake during app use
1 MONTH
This will be a safety evaluation to ensure that no participants had more than a 50% increase in fluid intake while using the app. It will be described using descriptive statistics.
Amount of interdialytic weight gain
1 MONTH
The amount of weight gain as recorded by use of the app for each interdialytic period. The association between the interdialytic weight gain and the fluid consumed will be assessed by a repeated measures analysis of variance with an unstructured covariance matrix.
Ratio of weight of liquid intake
1 MONTH
Agreement between fluid intake and weight gain will be described using descriptive statistics by the ratio of weight of liquid intake between two visits over the interdialytic weight gain
Number of days that the app was used
1 MONTH
This will be the determination of the number of days that the app was used.
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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 weight gain?

Among adults aged 18-34 years, the highest rate of excessive weight gains was observed among those who were dissatisfied with their physical appearance, had low physical activity and, respectively, overweight and obesity. We thus suggest that the issue of excessive weight gain deserves to be assessed seriously in overweight adolescents.

Anonymous Patient Answer

Can weight gain be cured?

There is no such thing as a 'cure' for weight gain or related obesity. Even if patients did not experience weight gain before the course of treatment, they are very likely to experience some post-treatment weight gain.

Anonymous Patient Answer

What causes weight gain?

A few key factors, such as excessive intake of high-calorie or high-protein foods, increased physical inactivity and increased environmental stress are among the causes of weight gain.

Anonymous Patient Answer

What are common treatments for weight gain?

There are a variety of non-pharmacological treatments that can be employed on patients with weight gain. There are many options, so it is common for therapists to take a thorough medical history to determine the correct treatment regimen in order to manage the symptom of weight gain.

Anonymous Patient Answer

What are the signs of weight gain?

It is important to remember that signs of weight gain can be very subtle and have no obvious cause. The following are some of the signs and symptoms of weight gain:\n- Difficulty walking\n- Excess weight in limbs\n- Decrease appetite\n- Difficulty with coordination: balance, gait, etc.\n\nPhysical\nPain, stiffness, redness or increased temperature, swelling in or around joints (in particular, joint pain), weakness of legs and decreased range of motion. The diagnosis of gout or rheumatoid disease is ruled out when these signs are present.

Anonymous Patient Answer

How many people get weight gain a year in the United States?

around 6% of U.S. households report that they did not have adequate food in their household once, every week during the past year. More than 40% of women reported that they stopped eating all or most of their food once, every week during the past year. Around 33% of U.S. women reported that they gained a total of 5% or more of body weight during the last 6 months. Fewer than 10% of U.S. households reported more than 20% of body weight gain during the previous year.

Anonymous Patient Answer

Who should consider clinical trials for weight gain?

Subjects with an existing BMI >25 kg/m(2) have no greater probability of experiencing unwanted weight gain than <25 subjects. Subjects without a BMI >25 kg/m(2) are more likely to have unwanted weight gain than <25 but are still able to gain a desired weight. Clinicians who wish to treat an individual with hyperphagia should begin by assessing the weight status of their patient using BMI. If the patient's BMI is <25 kg/m(2) then their ideal weight is >25 kg/m(2). If their weight is <25 kg/m(2) they may have unwanted weight gain.

Anonymous Patient Answer

Is survey typically used in combination with any other treatments?

Results demonstrate the benefits regarding the use of the survey as an integral part of treatment with other treatments (surgery). It may be recommended for such an application.

Anonymous Patient Answer

What is the latest research for weight gain?

In summary, our findings support the findings of previous studies: high-fat diet is highly linked with weight gain and associated with risk factors. However, the underlying mechanism for the link between high-fat diet and obesity is unclear. More research is needed to explore the exact pathways involved in the link between high-fat diet and weight gain and the role of vitamins, polyphenols and fatty acids in promoting weight gain.

Anonymous Patient Answer

What is the primary cause of weight gain?

The primary cause of weight gain is an increase in energy requirements. Secondary causes are an increase in energy intake, a change in energy balance, and other factors.

Anonymous Patient Answer

What is survey?

The patient’s current symptoms, their baseline symptoms if they experience any, and the degree of change the patient has experienced since their first symptoms do affect that person’s perception of the symptoms.

Anonymous Patient Answer

Is survey safe for people?

In general the survey proved to be safe for research participants. However, some methodological considerations remain to be examined further with respect to the conduct of the survey and the survey methodology for future surveys.

Anonymous Patient Answer
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