Patient Suitability

 

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INDICATIONS	CONTRAINDICATIONS	PRECAUTIONS	MEDICATIONS	PATIENT READINESS

 

Indications

The Intensive Level of the OPTIFAST VLCD Program (which is the VLED component) can be considered in individuals with a BMI ≥ 30kg/m², or a BMI ≥ 27kg/m² plus risk factors, reduced mobility, or a need for weight reduction before surgery.

Risk factors include:

• smoking
• hypertension
• dyslipidaemia
• hyperglycaemia
• family history of heart disease
• sleep apnoea

 

Medical supervision is advised when following a VLED program.

Many patients who require weight loss will not present to you asking for assistance. A proactive approach may be necessary.

A good way to identify patients who are suitable for a very low-calorie diet is to classify them by BMI or waist circumference, distribution of body fat, morbidity of complications, age, and readiness to commit.

In addition to the appropriate BMI, suitable patients may include those with:

1.  Waist circumference measurement:

•      >102cm in men and
•      >88cm in women

2.  A need for fast weight loss, e.g.:

•   prior to elective surgery,
•   to allow for increased mobility, or
•   an improvement of an obesity-related medical condition

3.  A history of unsuccessful weight loss attempts with diet and exercise, with or without pharmacotherapy

4.  Motivation and high readiness to undergo the strict supervision and discipline of the OPTIFAST VLCD Program.

 

If your patient's BMI is less than 30kg/m², and they have no risk factors, the Active 2 or Active 1 Level of the OPTIFAST VLCD Program may be more appropriate.

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Contraindications

 

Healthy Weight (BMI < 25kg/m² )
VLEDs should never be used by individuals that fall within the healthy weight range, i.e. BMI <25kg/m² because it may lead to excessive loss of lean body mass. If your patient's BMI is under 25kg/m² you may consider starting them on either the Active 2 or Active 1 levels of the OPTIFAST VLCD Program.

Pregnancy
Very low energy diets are contraindicated during pregnancy, as there is no evidence to indicate that a VLED is either beneficial or safe during this time. Following a VLED leads to elevated levels of ketones in the blood. Although the levels of ketones are relatively low, the effect on the foetus is unknown. In addition, the OPTIFAST VLCD Program is not designed to meet the increased nutrient requirements of pregnancy (e.g. protein, iron and some B group vitamins). Premenopausal women should be advised to take suitable contraception if on the Intensive Level of the OPTIFAST VLCD Program.  Please see the OPTIFAST VLCD Fertility Protocol for more information regarding the suitability and use of VLEDs and meal replacements in fertility, pregnancy, post-partum and gynaecological conditions.

Lactation
The Intensive Level of the OPTIFAST VLCD Program (replacing all three meals with OPTIFAST VLCD products) is not recommended for women who are fully breastfeeding as it is not designed to meet the increased nutritional demands of lactation. Patients may start on the Active 1 level (i.e. replacing one meal per day with an OPTIFAST VLCD product) or follow the Maintenance Level. They can gradually increase the amount of meals replaced once the baby has weaned off breast milk and is also consuming a reasonable quantity of solids.

Children <18 years
VLEDs are contraindicated in children who are still growing; however, there may be children in whom severe obesity is resistant to other treatments. In such individuals, the risks associated with obesity should be weighed against the risks of using a VLED and should only be prescribed and monitored by a qualified healthcare professional.

Presence of porphyria
Porphyria is the umbrella term for a group of rare disorders that involve a particular molecule called 'haem'. Haem contains iron and is used in metabolic processes throughout the body. Porphyria occurs when the body cannot convert naturally occurring compounds (called 'porphyrins') into haem. While all tissues have haem, those that use it the most are the red blood cells, liver and bone marrow. Porphyria can affect the skin, nervous system and gastrointestinal system, depending on the specific type. Porphyria is contraindicated with OPTIFAST VLCD as extreme calorie restriction can provoke an acute attack.

Recent myocardial infarction or unstable angina
Patients should be referred to a cardiologist to determine suitability for a VLED or severe calorie restriction. 

Liver Disease
Fast weight loss using a VLED is not recommended for patients with advanced liver disease. Fast weight loss induced by a VLED can induce a transient and reversible (2-6 weeks) rise in liver enzymes⁷.  In those with known hepatic disease or dysfunction, the OPTIFAST VLCD Program may be commenced at one of the lower levels, i.e. Active 2 or Active 1 and be stepped up toward the Intensive Level progressively over weeks while monitoring liver enzymes levels. 

For further information regarding the management of patients with Liver Disease and the use of OPTIFAST VLCD, please refer to the OPTIFAST VLCD Management of Complex Cases.

Renal Disease
While there is limited clinical data on the use of VLEDs in people with renal disease, they have shown to be effective in reducing weight and improving renal function without any reported adverse effects in these patients. However, such patients should be closely monitored to ensure that there is no disruption to electrolyte or fluid balance. Particular care needs to be taken in patients on a fluid restriction, and such patients should be monitored by a physician while on a VLED.

For further information regarding the management of patients with Renal Disease and the use of OPTIFAST VLCD, please refer to the OPTIFAST VLCD Management of Complex Cases.

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Precautions

 

Age >65 years
The Intensive Level of the OPTIFAST VLCD Program is generally not advised for use in persons over the age of 65 years.  Older people (aged > 70 years) have increased protein requirements due to an elevated anabolic resistance to ingested protein⁸. Recent research, however, indicates that VLEDs, in conjunction with exercise, has potential in the treatment of obesity in older persons under medical supervision⁹. Care must be taken to ensure nutritional requirements are met, in particular, protein. Research indicates that high protein (1.2g/kg/day) hypocaloric diets are required to maintain serum albumin in senior people with metabolic syndrome¹⁰. 

History of severe psychological disturbance, alcoholism or drug abuse
Individuals diagnosed with psychosis should only proceed with a VLED diet under the guidance of their medical practitioner. The medical practitioner must weigh up the benefits versus the risks. The psychotic state may lead to inappropriate and, or, unreliable use of the VLED, placing the patient at nutritional risk.

Cholelithiasis
Fast weight loss may induce the formation of gallstones. Where fat intake can sometimes be low with a VLED, the addition of fat (i.e. one teaspoon vegetable oil per day) to the Program has historically been prescribed to stimulate the emptying of the gall bladder and to prevent the formation of gallstones. OPTIFAST VLCD products now contain enough fat to stimulate contraction of the gall bladder and prevention of this problem. The addition of one teaspoon of vegetable oil to the Intensive Level can still be recommended to increase compliance and add variety and taste to the vegetables and salad. It is not absolutely necessary for the prevention of cholelithiasis. The OPTIFAST VLCD Bars, however, do not contain added omega-3 fatty acids, and therefore if consuming the OPTIFAST VLCD Bars only, the addition of the teaspoon of vegetable oil will be necessary.  Formation of gallstones can also be prevented with ursodeoxycholic acid in individuals predisposed to cholelithiasis.

Pancreatitis
Gallbladder problems may be associated with pancreatitis and, or cholangitis.  In patients with a suspected history of cholecystitis or gallstones, the potential for the development of pancreatitis must be considered and reviewed with the patient. Isolated acute pancreatitis has been reported only rarely during weight reduction, however, with a patient complaint of severe abdominal pain and, or elevated amylase or alkaline phosphatase, pancreatitis and, or cholangitis should be considered. If confirmed, the patient should postpone weight reduction until the condition is treated and resolved.

Electrolytes
Although the OPTIFAST VLCD Program contains adequate electrolytes for most individuals, some individuals may become hyponatremic or hypokalaemic, especially if they are receiving diuretic therapy. In such circumstances, electrolyte supplements may be required, or diuretic therapy reduced or stopped. In addition, when following a carbohydrate-restricted diet for more than two weeks, the body switches from retaining salt to rapidly excreting salt. If your patients experience side-effects such as weakness, fatigue, light-headedness, headache or constipation, consider adding 1-2 cups of stock, broth or bouillon to the daily meal plan¹¹.

Gout
Serum uric acid increases during the first weeks on a VLED. Despite this, attacks of gout are rare, although patients with a history of gout may occasionally develop an acute attack. In patients with a history of gout, it is essential to ensure an adequate fluid intake, and the addition of allopurinol 300mg daily may be considered.

Liver enzymes
Transient elevations of hepatocellular enzymes may occur through the Intensive Level of the OPTIFAST VLCD Program, but progressive elevation beyond three times the upper limit is abnormal and unusual. Elevations of liver enzyme values (SGOT, SGPT, ALT, GGT) occur in a significant number of morbidly obese patients. Sometimes such elevations are present at baseline and decrease to normal during weight loss.

Isolated elevations of hepatocellular enzymes and the absence of significant elevations of bilirubin, alkaline phosphatase or findings of acute disease, may not require further investigation or changes in dietary protocol. Significant elevation of bilirubin and, or alkaline phosphatase and gamma-glutamyl transpeptidase (GGT) with a progressive elevation of hepatocellular enzymes suggest intercurrent hepatic disease, such as hepatitis or pancreatitis and must be investigated.

Women menstrual cycle changes
Women may experience a variety of changes in their menstrual cycle during weight loss. Cycles may resume or decrease with weight loss and generally return to normal following re-feeding.

Fertility
Women previously unable to conceive (for example, due to polycystic ovarian syndrome PCOS) may ovulate and become fertile while on a weight loss program. Women should, therefore, be informed and take appropriate birth-control precautions. It is also recommended that women must avoid the 'Intensive Level' of the OPTIFAST VLCD Program while trying to conceive.  Even though the loss of weight may improve fertility in most cases, studies have shown that use of a VLED may compromise reproductive outcomes and may also result in an unsatisfactory IVF outcome, in individuals undertaking Assisted Reproductive Technology (ART)^{12, 13}.

Diaphragm usage
Women who are using a diaphragm for birth control may need to be referred to their Obstetrician/Gynaecologist for periodic checks on the fit, since fit may change as the patient loses weight.

To find out more about the OPTIFAST VLCD Program and medications, click here

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Medications

The use of a VLED may influence the dosage requirements of some medications. This is important for medications that have a narrow effective therapeutic range. The mechanisms that may alter requirements include:

• A significant change in the nature of dietary intake – macronutrient and micronutrient
• Significant negative energy balance and resultant fast weight loss
• Ketosis associated with fat catabolism
• Alterations in body composition with weight loss:

     – Reduced fat/lipid compartment 
     – Altered lean body mass 
     – Altered hydration.

Individuals receiving medication for Type 1 & Type 2 diabetes, hypertension, dyslipidaemia or those on lithium therapy may need a reduction in dose or withdrawal from their medication while undergoing a VLED program. For the recommendations of management for patients on any of the above medications, please refer to the OPTIFAST VLCD Management of Complex Cases. All individuals should be monitored carefully in the first few weeks of using a VLED.

No Interactions
The following list of medications can be used normally in patients on a VLED:

•     Minor tranquilisers
•     Antibiotics
•     Anti-emetics
•     Anti-diarrhoea agents
•     Antacids
•     Oral contraceptives
•     Oestrogen for the prevention of osteoporosis
•     Antihistamines

 

Use of Pharmacotherapy 

Due to the biological basis of obesity, some patients may require additional pharmacotherapy to assist in appetite suppression.

The OPTIFAST VLCD Program may be used in conjunction with prescription medications to facilitate weight loss.

Noradrenergic agonists (phentermine) have been used in conjunction with the OPTIFAST VLCD Program; however, given that there have been no long-term studies conducted with these agents, it is recommended that they are not used for more than three months.

We don't recommend other over the counter weight loss products or appetite suppressants be taken with OPTIFAST VLCD products. There is currently no clinical evidence to support the efficacy and safety of using products such as these in conjunction with the OPTIFAST VLCD Program.

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Patient Readiness

For a patient to succeed with the OPTIFAST VLCD Program, it is crucial to assess their readiness to undertake the necessary behaviour changes required for effective weight management. After physically assessing the patient and presenting the VLED program outline, it may be helpful to address then how important it is for the person to make the changes required as well as assess their level of confidence in making those changes.

If the patient's level of importance is low, then assisting the patient in identifying benefits or intrinsic motivators should be discussed. Also, if the patient's level of confidence is low then reducing the magnitude of the goals may be helpful, for example, aim at losing 5kg rather than 20kg, or starting with four weeks on the program rather than 12 weeks.

Alternatively, you can start a patient on the Active 2 or Active 1 Level if you feel that this would be more suitable for them. Work through and identify any barriers that may inhibit making the necessary lifestyle changes.

Once you can confirm that the patient is ready to move ahead with the program, then it is important to create some specific goals and an action plan. A stepwise approach is outlined below with some sample questions that can be used. 
 
Step 1 – Assess the level of importance

1.  How important do you think it is for you to make changes (i.e. lose weight) at the moment, given all the other priorities currently in your life? 

 

Step 2 – Assess the level of confidence

1.  How confident are you that you can change your diet and increase your physical activity to lose weight and improve your health?
2.  Do you feel you can succeed in losing weight right now? 

 

Step 3 – Help the patient to identify benefits or intrinsic motivators

1.  If you made some changes, what benefits do you think you would gain?
2.  If you made changes, how would your life be different from what it is today?
3.  How would you like things to turn out for you in 2 years?
4.  How would losing weight impact the things or people that are important to you? 

 
Step 4 - Identify obstacles or barriers

1.  Are there any stressful events in your life right now that might get in the way of you making the necessary changes?
2.  Have you tried to lose weight before? What got in the way of you achieving or maintaining your goals?
3.  What do you find most challenging about losing weight?
4.  What would be not so good about making the changes you are thinking about making?
5.  Are there people who can support you to lose weight? Do you think they will help you in your efforts? 
6.  How can I help you get past some of the difficulties you are experiencing?
7.  If you were to decide to change, what would you have to do to make this happen?

Step 5 – Confirm the level of readiness 

1.  On a scale from 1 to 10, where 1 is definitely not ready to change, and 10 is definitely ready to change, what number best reflects how willing you are at present to lose weight?
2.  How do you feel about making the necessary changes?

Step 6 – Set specific goals
Generating some specific goals is an integral part of the process with which the patient may need some assistance. Goals may include one or a combination of the following:

1.  Medical or clinical targets – a certain amount of weight loss, reducing blood pressure, reducing waist circumference, lowering BMI.
2.  Specific health goals – exercising four times per week, drinking 2 litres of water per day.
3.  Motivation goals – fitting into old clothes or a particular dress, not having to take hypoglycaemic medication any longer, being able to run a 5km fun run in 6 months. 

Step 7 – Create an action plan
An action plan should include as much detail as necessary for the client to feel confident that they can achieve the desired task. Some things to consider when creating an action plan are:

1.  All the steps needed to overcome barriers and achieve a personal goal.
2.  When and how to follow the program.
3.  Prompts to aid memory where necessary.
4.  Support mechanisms.
5.  Contingency plans.
6.  Tracking and monitoring strategies.
7.  Review details.

Help your client determine an achievable weight loss goal by calculating their ideal body weight.  Learn more about how to calculate this here.Calculating ideal body weight (IBW).

Ideal body weight is calculated to help determine an appropriate weight for height or to establish a long-term weight loss goal. However, when estimating an Ideal Body Weight or Goal Weight for individuals with a BMI 30kg/m² calculating, the 'Obesity Adjusted Ideal Body Weight' (Adj IBW) is a common approach^{14, 15}.

This equation allows for 25% of excess metabolically active body weight (lean muscle mass), giving you a more appropriate estimate of an Ideal Body Weight for that individual. Aiming for a goal within the healthy weight range may not be relevant or realistic for all patients.

It is important to remember that a 5-10% weight loss can result in significant reductions in co-morbidities and improvements in health outcomes. Therefore small incremental weight losses as short term goals can result in substantial health benefits.

 

Use this table to work out what the Ideal Body Weight (IBW) at a BMI of 25 is for your patient’s height

 

Meeting protein requirements while losing weight is important to protect lean muscle tissue.  Learn more about how to calculate protein requirements here.