Informed Consent Related to Treatment of Weight Loss Conditions

Purpose

The purpose of this informed consent form is to make sure you are aware of the potential benefits and risks of starting a weight loss program.

It is vitally important for you to advise your health care provider(s) of ANY concerns, problems, complaints, symptoms, or questions even if you may think it is not terribly important or even related. This is so the provider team can determine the best course of treatment. Keeping your care team informed of any questions or symptoms you have affords the best chance of providing you with necessary information, targeted and effective treatment, and developing a sustainable path forward.

Potential Benefits

Medically significant weight loss (usually about 10 percent of initial weight, or as an example, losing 20 pounds from a 200 pound starting weight) can:

Lower blood pressure, reducing the risks of hypertension;
Lower cholesterol, reducing the risks of heart and vascular disease;
Lower blood sugar, reducing the risks of diabetes.

If you are taking medications for one or more of these conditions, dosages may need to be adjusted as your overall health improves. You agree to advise your primary care provider and any other provider who may be treating you for any acute or chronic health condition, not just the ones listed above, that you are enrolled in Rejuva Meds’ program. Those providers need to have that information to adequately monitor and treat you, to assess/reassess your need for these medications, and take whatever other actions they deem necessary or prudent.

Other benefits may also be obtained but cannot be guaranteed. Increasing activity level can favorably affect the above conditions (and many others) and may have the additional benefit of helping you sustain weight loss. Weight loss and increased activity may provide important psychological and social benefits, as well.

Possible Side Effects and Risks

General

The possibility always exists in medicine that the combination of any significant disease with methods employed for its treatment may lead to previously unobserved or unexpected ill effects, including death. Should one or more of these ill effects occur, additional medical or surgical treatment may be necessary, and it may be necessary to cease the treatment you are receiving from Rejuva Meds. In addition, it is conceivable that other side effects could occur, including those which have not yet been diagnosed or observed.

Reduced Weight

When you reduce the number of calories you eat to a level lower than the number of calories your body uses in a day, you lose weight. As a result of this weight loss, your body makes some other adjustments in body processes. Some of these adjustments are responsible, in some participants, for improvements in blood pressure and blood sugar. However, you also may experience other temporary side effects or discomforts, including an initial loss of body fluid through increased urination, momentary dizziness, a reduced metabolic rate or metabolism (the rate at which you convert food to energy), sensitivity to cold, a slower heart rate, dry skin, fatigue, diarrhea or constipation, bad breath, muscle cramps, a change in menstrual pattern, dry and brittle hair or hair loss. Generally, these responses are temporary and resolve when calories are increased after the period of weight loss. You agree to advise Rejuva Meds and your other treating providers if you experience any of these issues.

Reduced Potassium Levels

Low potassium levels can cause serious heart irregularities. When someone has been on a reduced calorie diet, a rapid increase in calorie intake, especially overeating or binge-eating, can be associated with bloating, fluid retention, disturbances in salt and mineral balance, or gallbladder attacks and abdominal pain. Rejuva Meds providers may choose to order laboratory testing to confirm your levels are within acceptable limits. Failure to obtain these tests may result in a temporary cessation of treatment.

Gallstones

Overweight people develop gallstones at a rate higher than normal weight individuals. The occurrence of symptomatic gallstones (pain, diagnosed stones and/or surgery) in individuals 30 percent or more over desirable body weight (50 pounds or more overweight) not undergoing current treatment for obesity is estimated to be 1 in 100 annually, and for individuals who are 20-30 percent overweight, about one-half that rate, or 1 in 200 annually. It is possible to have gallstones and not know it. One study of individuals entering a weight loss program showed that as many as 1 in 10 had “silent” gallstones at the onset. As body weight and age increase, so do the chances of developing gallstones. These chances double for women, women using estrogen, and smokers. Losing weight, especially rapidly, may increase the chances of developing stones or sludge and/or increasing the size of existing stones within the gallbladder. The most common symptoms of gallstones are fever, nausea, and a cramping pain in the right upper abdomen. If you develop any of these symptoms or if you know or suspect that you may already have gallstones, let your provider team and primary care provider know immediately. Gallbladder problems may require medication or surgery to remove the gallbladder, and, less commonly, may be associated with more serious complications of inflammation of the pancreas or even death.

Pancreatitis

Pancreatitis, or an inflammation or infection in the bile ducts, may be associated with the presence of gallstones and the development of sludge or obstruction in the bile ducts. The symptoms of pancreatitis include pain in the left upper abdominal area, nausea, and fever. Pancreatitis may be precipitated by binge-eating or consuming a large meal after a period of dieting. Also associated with pancreatitis is a long-term abuse of alcohol and the use of certain medications and increased age. Pancreatitis may require surgery and may be associated with more serious complications and death.

Pregnancy

If you become pregnant, you should immediately stop any and all of your weight loss medications, and report this to your care team and primary care provider immediately. Your diet must be changed promptly to avoid further weight loss because a restricted diet could be damaging for a developing fetus. You must take precautions to avoid becoming pregnant during the course of weight loss.

Binge Eating Disorders

Binge eating disorder is defined as the habitual, uncontrolled consumption of a large amount of food in a short period of time. Participation in a calorically restricted diet has been shown in one study to increase binge eating episodes temporarily. Several other studies have demonstrated reduced episodes of binge eating following a calorie deficit and portion-controlled diet. Extended binge eating episodes are associated with weight gain.

The Risk of Weight Regain

Obesity is a chronic condition, and the majority of overweight individuals who lose weight have a tendency to regain all or some of it over time. Factors that help to maintain a reduced body weight include regular physical activity, adherence to a restricted calorie, low fat diet, and planning a strategy for coping with weight regain before it occurs. Successful treatment may take months or even years. Medical studies of calorie deficit/portioned-controlled diets (including modified fasting) have shown varying results for patients who maintain weight loss. Some studies have shown that fewer than 5% of weight loss patients were able to maintain a reduced body weight after five years. Another study showed that after three years, weight loss patients, on average, maintained about one half of their initial weight loss. If you have had fluctuations in your weight in the past, it may be more difficult to maintain the weight you lose during and after this program. A published medical study indicated people whose body weight fluctuates greatly or often have a higher risk of heart disease and death compared with persons of relatively stable body weight, and such weight fluctuations may play a role in the development of other chronic diseases.

Sudden Death

Patients with severe obesity, particularly those with serious hypertension, coronary artery disease, or diabetes mellitus, have a statistically higher chance of suffering sudden death when compared to normal weight people without such medical problems.

Scope of Services, Primary Care, and Emergency Medical Care

Rejuva Meds provides medical evaluation, monitoring, and treatment specifically related to weight management. The weight management program is not intended to replace comprehensive primary care, routine preventive care, specialist care, urgent care, or emergency medical services.

You are encouraged to establish and maintain an ongoing relationship with a primary care provider for preventive services, routine health maintenance, management of acute and chronic medical conditions, and concerns unrelated to your weight management treatment. You agree to inform your primary care provider and other treating healthcare professionals of your participation in the Rejuva Meds weight management program and of any medications prescribed through the program.

Rejuva Meds does not provide emergency medical services. Electronic messages, telephone calls, portal communications, emails, and prescription requests may not be reviewed immediately and should not be used for urgent or emergency concerns.

If you experience severe or persistent abdominal pain, persistent vomiting or inability to keep fluids down, chest pain, difficulty breathing, fainting, severe weakness, signs of dehydration, swelling of the face, lips, tongue, or throat, signs of a severe allergic reaction, or any other potentially life-threatening symptom, call 911 or seek immediate evaluation at the nearest emergency department. Do not delay emergency medical care while waiting for a response from Rejuva Meds.

Florida Weight Loss Consumer Bill of Rights

(A) WARNING: Rapid weight loss may cause serious health problems. Rapid weight loss is weight loss of more than 1 1/2 pounds to 2 pounds per week or weight loss of more than 1 percent of body weight per week after the second week of participation in a weight-loss program.

(B) Consult your personal physician before starting any weight-loss program.

(C) Only permanent lifestyle changes, such as making healthful food choices and increasing physical activity, promote long-term weight loss.

(D) Qualifications of this provider are available upon request.

(E) You have the right to:

Ask questions about the potential health risks of this program and its nutritional content, psychological support, and educational components.
Receive an itemized statement of the actual or estimated price of the weight-loss program, including extra products, services, supplements, examinations, and laboratory tests.
Know the actual or estimated duration of the program.
Know the name, address, and qualifications of the dietitian or nutritionist who has reviewed and approved the weight-loss program according to s. 468.505(1)(j), Florida Statutes.