AONAA
`
`US 20060064037A
`
`(19) United States
`a2) Patent Application Publication co) Pub. No.: US 2006/0064037 Al
`(43) Pub. Date: Mar. 23, 2006
`
`Shalon et al.
`
`(54)
`
`(75)
`
`SYSTEMS AND METHODS FOR
`MONITORING AND MODIFYING
`BEHAVIOR
`
`Related U.S. Application Data
`
`(60)
`
`Provisional application No. 60/612,292, filed on Sep.
`22, 2004.
`
`Inventors: Tadmor Shalon, Palo Alto, CA (US);
`Tidhar Shalon, Tel-Aviv (IL)
`
`Publication Classification
`
`Correspondence Address:
`Martin Moynihan
`PRTSI, Inc.
`P.O. Box 16446
`
`Arlington, VA 22215 (US)
`
`(73)
`
`Assignee: Shalon Ventures Research, LLC
`
`(21)
`
`Appl. No.:
`
`11/230,645
`
`Filed:
`
`Sep. 21, 2005
`
`(51)
`
`(52)
`
`Int. Cl.
`(2006.01)
`A6IB 7/00
`UWS. Ch.
`cessssssssvesssseveesssee 600/586; 128/903; 128/905
`
`ABSTRACT
`(57)
`Asystemfor detecting non-verbal acoustic energy generated
`by a subject
`is provided. The system includes a sensor
`mountable on or in a body region ofthe subject, the sensor
`being capable ofsensing the non-verbal acoustic energy; and
`a processing unit being capable of processing the non-verbal
`acoustic energy sensedby the sensor andderiving an activity
`related signature therefrom, thereby enabling identification
`of a specific activity associated with the non-verbal acoustic
`energy.
`
`(22
`
`
`
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`Apple Inc.
`APL1056
`U.S. Patent No. 8,652,040
`
`Apple Inc.
`APL1056
`U.S. Patent No. 8,652,040
`
`0001
`
`

`

`Patent Application Publication Mar. 23,2006 Sheet 1 of 12
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`US 2006/0064037 Al
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`Patent Application Publication Mar. 23,2006 Sheet 2 of 12
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`US 2006/0064037 Al
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`Patent Application Publication Mar. 23,2006 Sheet 7 of 12
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`US 2006/0064037 Al
`
`Mar.23, 2006
`
`SYSTEMS AND METHODS FOR MONITORING
`AND MODIFYING BEHAVIOR
`
`RELATED APPLICATIONS
`
`(0001] The present application claims priority from U.S.
`Provisional Patent Application No. 60/612,292,filed on Sep.
`22, 2004. The content of the above Application is incorpo-
`rated herein by reference.
`
`PIELD AND BACKGROUNDOFTHE
`INVENTION
`
`[0002] The present inventionrelates to systems and meth-
`ods for monitoring and modifying behavior of a subject such
`as a human or an animal.
`
`[0003] Successful dieting requires long-term behavior
`modification in terms of eating and physical activity. A diet
`plan is only part of the solution. Sticking to the plan requires
`behavior modification that is generally beyondthe ability of
`most people to implement without external assistance. There
`does not appearto be a diet or process by which people can
`reliably lose weight and keep it off. Numerous studies have
`shown 100% weight regain on most diets, Other meta-
`studies show that people regain approximately 75% of the
`initial weight loss after five years.
`
`the net difference
`i.e.
`{0004] Assessing energy balance,
`between energy intake and expenditure is central to obesity
`research, prevention, and treatment. The importance of
`accurately measuring energy balance is appreciated by con-
`sidering the dynamics of average weight gain in middle aged
`adults which is about 10 Ibs. per decade. This significant
`gain in weight follows from a net intake excess of approxi-
`mately 0.3% of the daily calorie consumption, which is
`below the awareness of most individuals. [National Insti-
`tutes of Health, Bioengineering Approaches To Energy
`Balance And Obesity (SBIR/STTR). http://grants1.nih.gov/
`grants/guide/pa-files/PA-04-156.html].
`
`[0005] Today, energy intake is at best only crudely mea-
`sured by self reporting food consumed, an approach that
`nutritionists know falls well short of its accuracy goals.
`Although standard self-report questionnaire and recall tech-
`niques can provide valuable data on dietary patterns, these
`techniques are time consuming, inconvenient, and infamous
`for considerable underreporting of food consumed, with this
`error more pronounced for over weight
`than non-over
`weight individuals.
`
`to
`[0006] Several devices and methods which attempt
`overcomethe deficiencies of self reporting approaches have
`been describedin the prior art.
`
`{0007] U.S. Pat. No. 6,135,950 describes a pager size
`device to aid in controlling a person’s daily food intake. U.S.
`Pat. No. 5,398,688 describes a timer for calculating and
`alerting a user when their maximum eating time has expired.
`U.S. Pat. Nos. 5,188,104 and 5,263,480 describe the treat-
`ment of eating disorders by nerve stimulation by detecting
`preselected events indicative of imminent need for treatment
`and applying predetermined stimulating signal to patient
`vagus nerve. PCT Publication WO 02/053093 and U.S.
`application Publication No. 2004/0147816, describe a simi-
`lar invasive technique except that the stimulation is driven
`into the stomach muscle of the subject, thereby altering the
`timing of digestion. PCT Publication No. WO 02/026101,
`
`describes a generic arrangement of implantable sensors,
`microprocessors and a negative-feedback stimulator which
`can enforce a corrective regimen on a patient suffering from
`a dietary or other behavioral disorder.
`
`[0008] Unfortunately none of the approaches described
`above have been shown tobe effective. The only non-drug
`interventions for losing weight that display some long-term
`efficacy are the various procedures to reduce the volume of
`the stomach or bypass it altogether so that just a small
`volume of
`food may satiate the patient. While such
`approaches show some promise, they require invasive sur-
`gical procedures with attendant risks and pain, they often
`require permanent prosthetic implants and/or irreversible
`modification of the patient’s digestive tract with potentially
`serious complications and side effects, they are costly, and
`they require long recovery time during which the patient is
`immobile and unproductive. Many of those who are over-
`weight or obese are thus unable or unwilling to undergo such
`interventions.
`
`[0009] There is thus a widely recognized need for, andit
`would be highly advantageous to have, a system and method
`for controlling eating behavior without
`the invasiveness,
`risks, pain, complications, cost, and recovery lime associ-
`ated with stomach volume reduction and bypass procedures.
`
`SUMMARY OF THE INVENTION
`
`[0010] According to one aspect of the present invention
`there is provided a system for detecting activity related to
`non-verbal acoustic energy generated by a subject compris-
`ing: (a) a sensor mountable on or in a body region ofthe
`subject, the sensor being capable of sensing the non-verbal
`acoustic energy; and (b) a processing unit being capable of
`processing the non-verbal acoustic energy sensed by the
`sensor and deriving an activity related signature therefrom,
`thereby enabling classification of a specific activity associ-
`ated with the non-verbal acoustic energy.
`
`(0011] According to further features in preferred embodi-
`ments of the invention described below,
`the sensor is a
`microphone.
`[0012] Accordingto still further features in the described
`preferred embodiments the sensor is a bone conduction
`microphone.
`
`[0013] Accordingto still further features in the described
`preferred embodiments the sensor is mountable on a head of
`the subject.
`
`[0014] According to still further features in the described
`preferred embodiments the sensor is mountable behind the
`ear,
`
`(0015] Accordingto still further features in the described
`preferred embodiments the sensor is implantable.
`
`(0016] Accordingto still further features in the described
`preferred embodiments the sensor and the processing unit
`are housed in a single device.
`
`[0017] Accordingto still further features in the described
`preferred embodiments the sensor and the processing are
`separately housed.
`
`[0018] Accordingto still further features in the described
`preferred embodiments the system further comprises at least
`one addition sensor selected from the group consisting of a
`
`0014
`
`0014
`
`

`

`US 2006/0064037 Al
`
`Mar.23, 2006
`
`rate sensor, an accelerometer, a skin conductance
`heart
`sensor, a muscle tone sensor, a blood sugarlevel sense, a bite
`sensor and a stomach contraction sensor.
`
`[0019] According to still further features in the described
`preferred embodiments the system further comprises at least
`one feedback device.
`
`(0020] According to still further features in the described
`preferred embodiments the at least one feedback device is a
`speaker.
`
`(0021] According to still further features in the described
`preferred embodiments the at least one feedback device is
`selected from the group consisting of lights, a graphical
`display, an electrical stimulation device, a buzzer, a vibrat-
`ing element and a chemical dispensing unit.
`
`[0022] Accordingto still further features in the described
`preferred embodiments the processing unit forms a part of a
`device selected from the group consisting of a PDA,a cell
`phone, a wristwatch, a portable media player and a com-
`puter.
`
`[0023] Accordingto still further features in the described
`preferred embodiments the sensor is mountable within an
`ear canal of the subject.
`
`[0024] According to still further features in the described
`preferred embodiments the sensor is mountable within the
`oral cavity of the subject.
`
`(0025] According tostill further features in the described
`preferred embodiments the at least one feedback device and
`the at least one sensor are housed within a single device.
`
`[0026] Accordingto still further features in the described
`preferred embodiments the at least one feedback device and
`the at least one sensor are a single device.
`
`[0027] Accordingto still further features in the described
`preferred embodiments the sensor and the processing unit
`are connected through a wired connection.
`
`{0028] According to still further features in the described
`preferred embodiments the sensor and the processing unit
`are connected through a wireless connection.
`
`[0029] Accordingto still further features in the described
`preferred embodiments the wireless connection is effected
`through radiofrequency or infrared.
`
`[0030] According to another aspect of the present inven-
`tion there is provided a system for monitoring ingestion
`activity of a subject comprising: (a) a sensor mountable on
`or in a body region ofthe subject, the sensor being capable
`of sensing ingestion related motion or acoustic energy; and
`(b) a processing unit being capable of processing the inges-
`tion related motion or acoustic energy and deriving an
`ingestionactivity related signature therefrom, thereby moni-
`loring ingestion activity of the subject.
`
`[0031] Accordingto still further features in the described
`preferred embodiments the ingestion related motion or the
`acoustic energy is generated by jaw motion.
`
`[0032] Accordingto still further features in the described
`preferred embodiments the ingestion related motion or the
`acoustic energy is generated by stomach contractions or
`bowel motility.
`
`[0033] According to still further features in the described
`preferred embodiments the ingestion related motion or
`acoustic energy is generated by biting, chewing or swallow-
`ing.
`
`[0034] Accordingtostill further features in the described
`preferred embodiments the acoustic energy is non-verbal
`acoustic activity.
`
`[0035] Accordingto still further features in the described
`preferred embodiments the sensor is mountable within the
`oral cavity of the subject.
`
`[0036] Accordingto still further features in the described
`preferred embodiments the ingestion activity related signa-
`ture identifies a
`type and/or quantity of food or drink
`consumed.
`
`[0037] According to yel another aspect of the present
`invention there is provided a method of detecting activity
`related to non-verbal acoustic energy generated by a subject
`comprising: (a) sensing the non-verbal acoustic energy; and
`(b) processing the non-verbal acoustic energy and deriving
`an activity related signature therefrom,
`thereby enabling
`classification of a specific activity associated with the non-
`verbal acoustic energy.
`
`[0038] Accordingto still further features in the described
`preferred embodiments(a) and(b) are conducted over a time
`period such that a plurality of activity related signaturesare
`obtained.
`
`[0039] Accordingto still further features in the described
`preferred embodiments the method further comprises (c)
`processing the plurality of activity related signatures to
`thereby infer a behavior of the subject.
`[0040] Accordingto still further features in the described
`preferred embodiments the method further comprises (d)
`providing feedback to the subject intended to modify the
`behavior of the subject.
`
`[0041] According to still further features in the described
`preferred embodiments the activity related to non-verbal
`acoustic energy is eating or drinking.
`
`(0042] Accordingto still further features in the described
`preferred embodiments the specific activity is breathing.
`
`[0043] According to still another aspect of the present
`invention there is provided a method of monitoring ingestion
`activity of a subject comprising: (a) sensing ingestion related
`motion or acoustic energy; and (b) processing the ingestion
`related motion or acoustic energy and deriving an ingestion
`activity related signature therefrom,
`thereby monitoring
`ingestion activity of the subject,
`
`[0044] Accordingto still further features in the described
`preferred embodiments (a) and(b) are conducted over a time
`period such that a plurality of ingestion activity related
`signatures are obtained.
`
`[0045] Accordingto still further features in the described
`preferred embodiments the method further comprises (c)
`processing the plurality of ingestion activity related signa-
`tures to thereby determine a ingestion behavior of the
`subject.
`
`[0046] Accordingto still further features in the described
`preferred embodiments the ingestion activity related signa-
`ture identifies consumption of a specific food item.
`
`0015
`
`0015
`
`

`

`US 2006/0064037 Al
`
`Mar.23, 2006
`
`[0047] According to an additional aspect of the present
`invention there is provided a method of accumulating data
`relating to ingestion behavior of a subject comprising (a)
`monitoring ingestion related activity of the subject over a
`time period; (b) generating a signature classifying the inges-
`tion related activity of the subject over the time period; (c)
`computationally logging the signature thereby accumulating
`data relating to ingestion behavior of the subject.
`
`[0048] According to still further features in the described
`preferred embodiments the method further comprising asso-
`ciating the signature with a duration of ingestion, rate of
`ingestion, food mass, volume, caloric value or nutritional
`value of material ingested prior to, or following step (c).
`
`[0049] Accordingto still further features in the described
`preferred embodiments the method further comprises aggre-
`gating the data relating to ingestion behavior for a plurality
`of subjects into a database.
`
`[0050] Accordingto still further features in the described
`preferred embodiments
`the method further comprises
`repeating steps (a)-(c) thereby accumulating data compris-
`ing a plurality ofdistinct signatures,
`
`[0051] Accordingto still further features in the described
`preferred embodiments(a) is effected by counting a number
`of bites chews and/or swallows over the time period.
`
`(0052] According tostill further features in the described
`preferred embodiments the signature reflects the number of
`bites chews and/or swallows over the time period.
`
`[0053] Accordingto still further features in the described
`preferred embodiments the signature further
`reflects a
`sequence of the bites chews and/or swallows over the time
`period.
`[0054] Accordingto still further features in the described
`preferred embodiments the counting is effected by user
`mounted device.
`
`[0055] Accordingto still further features in the described
`preferred embodiments the device is capable of sensing
`ingestion activity related motion or acoustic energy.
`
`[0056] According to an additional aspect of the present
`invention there is provided a computer readable medium
`comprising a database stored therein the database including
`a plurality of signatures each classifying an ingestion related
`activity of a subject over a time period.
`
`[0057] According to still further features in the described
`preferred embodiments the database contains ingestion
`related activity collected from a plurality of subjects.
`
`(0058] Accordingto still further features in the described
`preferred embodiments the signature reflects a number of
`bites chews and/or swallows over the time period.
`
`(0059] Accordingto still further features in the described
`preferred embodiments the signature further
`reflects a
`sequence of the bites chews and/or swallows over the time
`period
`
`[0060] According to an additional aspect of the present
`invention there is provided a device for monitoring food
`and/or drink consumption of a subject comprising (a) a
`sensor for sensing ingestion activity of the subject; and (b)
`at least one feedback device for providing feedback relating
`to the ingestion activity to the subject.
`
`[0061] Accordingto still further features in the described
`preferred embodiments the device further comprises a pro-
`cessing unit for processing ingestion activity sensed by the
`sensor.
`
`[0062] Accordingtostill further features in the described
`preferred embodiments the device further comprises a data
`input unit capable of being programmed with the weight,
`body mass index or fat content of the subject.
`
`[0063] Accordingto still further features in the described
`preferred embodiments the device further comprises a
`memory unit storing a database including ingestion activity
`of the subject.
`
`[0064] According tostill further features in the described
`preferred embodiments the feedback provided by the feed-
`back device is determined by the device according to the
`database.
`
`(0065] Accordingto still further features in the described
`preferred embodiments the device further comprises a
`memory unit storing a database including desired ingestion
`behavior of the subject.
`
`{0066] According tostill further features in the described
`preferred embodiments the feedback provided by the feed-
`back device is determined by the device according to the
`desired ingestion behavior ofthe subject.
`
`[0067] Accordingto still further features in the described
`preferred embodiments the at least one feedback device is
`capable of providing audio feedback.
`
`{0068] According tostill further features in the described
`preferred embodiments the device further comprising a data
`transfer unit for transmitting data pertaining to the ingestion
`activity of the subject.
`
`(0069] Accordingto still further features in the described
`preferred embodiments the data transfer unit forms a part of
`a transceiver.
`
`(0070] Accordingto still further features in the described
`preferred embodiments the device further comprises a
`microphone for receiving acoustic inpul from the subject.
`
`[0071] Accordingto still further features in the described
`preferred embodiments the device further comprises a pro-
`cessing unit
`for processing the acoustic input from the
`subject into data relatable to the ingestion activity sensed by
`the device.
`
`(0072] According to an additional aspect of the present
`invention there is provided a device for monitoring food
`and/or drink consumption of a subject comprising (a) a
`sensor for sensing ingestion activity of the subject; and (b)
`a data transfer unit for transmitting data relating to the
`ingestion activity of the subject.
`
`(0073] The present invention successfully addresses the
`shortcomings of the presently known configurations by
`providing a system and methodof detecting activity patterns
`and feeding back information about these activity patterns to
`the user in real time.
`
`[0074] Unless otherwise defined, all technical and scien-
`tific terms usedherein have the same meaning as commonly
`understood by one ofordinary skill in the art to which this
`invention belongs. Although methods and materials similar
`or equivalent to those described herein can be used in the
`
`0016
`
`0016
`
`

`

`US 2006/0064037 Al
`
`Mar.23, 2006
`
`practice or testing ofthe present invention, suitable methods
`and materials are described below. In case ofconflict, the
`patent specification, including definitions, will control. In
`addition, the materials, methods, and examples are illustra-
`tive only and not intended to be limiting.
`
`Implementation of the method and system of the
`[0075]
`invention involves performing or completing
`present
`selected tasks or steps manually, automatically, or a combi-
`nation thereof. Moreover, according to actual instrumenta-
`tion and equipment of “preferred embodiments of the
`method and system of the present invention, several selected
`steps could be implemented by hardware or by software on
`any operaling system of any firmware or a combination
`thereof. For example, as hardware, selected steps of the
`invention could be implemented as a chip or a circuit. As
`software, selected steps of the invention could be imple-
`mented as a plurality of software instructions being executed
`by a computer using any suitable operating system. In any
`case, selected steps of the method and system of the inven-
`tion could be described as being performed by a data
`processor, such as a computing platform for executing a
`plurality of instructions.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`(0076] The invention is herein described, by way of
`example only, with reference to the accompanying drawings.
`With specific reference now to the drawings in detail, it is
`stressed that the particulars shown are by way of example
`and for purposesofillustrative discussion of the preferred
`embodiments of the present invention only, and are pre-
`sented in the cause of providing what is believed to be the
`most useful and readily understood description of the prin-
`ciples and conceptual aspects of the invention. In this regard,
`noattempt is made to show structural details of the invention
`in more detail than is necessary for a fundamental under-
`standing of the invention,
`the description taken with the
`drawings making apparent to those skilled in the art how the
`several forms of the invention may be embodied in practice.
`
`[0077]
`
`In the drawings:
`
`(0078] FIGS. la-d illustrate several embodiments ofthe
`system ofthe present invention being worn in or around the
`ear and communicating with a processing unit via wired or
`wireless connection;
`
`[0079] FIG. 2 schematically illustrates the hardware com-
`ponents of one embodiment of a diet control system con-
`structed according to the teachings of the present invention;
`
`[0080] FIG. 3 is a flow chartillustrating an eating micro-
`structure model;
`
`[0081] FIG, 4 is a data flow diagram of the software
`components of the system of the present invention;
`
`[0082] FIG. 5 is a flow chart diagram showing various
`layers of the system network as an integrated system;
`
`[0083] FIG. 6 illustrates an embodiment of the present
`system in which an ear piece sends data or sound to a belt
`unit through wired or wireless communication;
`
`[0084] FIG. 7 illustrates an embodiment of the present
`system in which an ear piece and a belt unit can engage in
`two-way communication of data and/or sound through wired
`or wireless communication;
`
`[0085] FIG. 8 illustrates hardware components ofa wire-
`less transponder anda user interface unit;
`
`(0086] FIG. 9 illustrates the synchronization and auto-
`matic calibration of transponderdata utilized by the system
`depicted in FIG. 8;
`
`[0087] FIG. 10 is a captured screen image of a sound
`sequence manually labeled and analyzed for eating micro-
`structure events;
`
`[0088] FIG. 11 is a time trace of the acoustic energy
`generated by the heart as detected by a bone conduction
`microphone in the ear of a human subject;
`
`[0089] FIG. 12 is a power spectrum ofbreathing sounds
`as detected by a bone conduction microphone in the ear of
`a human subject;
`
`[0090] FIG. 13 is a trace of accelerometer and microphone
`signals of chewing activity; and
`
`[0091] FIG. 14 isa trace of jogging activity as detected by
`a head-mounted microphone.
`
`[0092] DESCRIPTION
`EMBODIMENTS
`
`OF
`
`THE
`
`PREFERRED
`
`{0093] The present invention is of a system and method
`which can be used to monitor and optionally modify a
`behavior ofa subject. Specifically, the present invention can
`be used to monitor an eating behavior of a subject and
`provide real-time feedback for modifying such behavior.
`
`[0094] The principles and operation of the present inven-
`tion may be better understood with reference to the drawings
`and accompanying descriptions.
`
`[0095] Before explaining at least one embodiment of the
`invention in detail, it is to be understood that the invention
`is not limited in its application to the details set forth in the
`following description or exemplified by the Examples. The
`invention is capable of other embodiments or of being
`practiced or carried out in various ways. Also, it is to be
`understood that the phraseology and terminology employed
`herein is for the purpose of description and should not be
`regarded as limiting.
`
`[0096] Numerous approaches for modifying eating habits
`are knownin the art. Although some benefits can be gained
`from using such approaches, none provide an ideal diet
`control solution as is evidenced by the growing need for new
`solutions for treating eating disorders such as obesity or
`anorexia,
`
`[0097] Real-time feedback based on the microstructure of
`eating holds promise as a new tool
`for the behavioral
`modification of eating. Although research in this area has
`been hampered by the unavailability of analytical monitor-
`ing systems that can be used during the course of a person’s
`daily life (Bellisle, F., B. Guy-Grand, et al. “Chewing and
`swallowing as indices of the stimulation to eat during meals
`in humans: effects revealed by the edogram method and
`video recordings.” Neurosci Biobehav Rev 24(2):; 223-8.),
`laboratory andclinical studies suggestthe ability for achiev-
`ing weight control by using eating microstructure events.
`
`[0098] Studies have hinted at the benefits of monitoring
`and modifying consumption patterns.
`
`0017
`
`0017
`
`

`

`US 2006/0064037 Al
`
`Mar.23, 2006
`
`[0099] For example, a 1985 study by Stellar and Shrager
`demonstrated that over a year or more,
`the number of
`swallows on any given day correlated more highly with
`weight gain on the following day than did user-derived
`estimates ofcaloric intake. [*Chews and swallows and the
`microstructure of eating.” Am J Clin Nutr 42(5 Suppl):
`973-82].
`In addition, studies have also correlated between
`[0100]
`consumption rate and patterns and caloric intake. For
`example, in 1977 Meyer and Pudel demonstrated that non-
`obese persons regularly slow their rate of eating during the
`course of a twenty minute test meal, while obese persons
`tend not to do so. [“Experimental feeding in man: a behav-
`ioral approach to obesity.” Psychosom Med39(3): 153-7]; in
`1972 Stuart and Davis demonstrated that smaller bites may
`result in slower ingestion rates. (Slim chance in a fat world:
`behavioral control of obesity. Illinois, Research Press); in
`1984, Clifton et al. demonstrated that pausing between bites
`may lead to reduced meal size. [“Feeding rate and meal
`patterns in the laboratory rat.” Physiol Behav 32(3): 369-
`74]; in 1980, Kaplan demonstrated that eating faster results
`in higher consumption. [“Eating style of obese and non-
`obese males.” Psychosom Med 42(6): 529-38];
`in 1966
`Jordan et al. showed that the degree of hunger determines
`the initial rate of ingestion. (“Direct measurement of food
`intake in man: a method for the objective study of eating
`behavior.” Psychosom Med 28: 836-842); in 1977 Meyer
`and Pudel postulated that having obese people slow down
`may reduce consumption [“Experimental feeding in man: a
`behavioral approach to obesity.<* Psychosom Med 39(3):
`153-7]; in 1989 Spiegel et al, demonstrated that avoiding
`prolonged periods of non-eating that are followed by eating
`highly preferred foods reduces consumption. [“Responses of
`lean and obese subjects to preloads, deprivation, and palat-
`ability.” Appetite 13(1): 45-69];
`in 2000, Spiegel et al.
`demonstrated that obese people eat faster than people who
`are not obese, eat more food and more energy dense food, eat
`desert earlier then non-obese people and thus, by deferring
`or avoiding desert, consumption of obese people should will
`drop [Rate ofintake, bites, and chews-the interpretation of
`lean-obese differences.” Neurosci Biobehav Rev 24(2): 229-
`37]; in 2000, Bellisle et al showed that eating rate increases
`with food that tastes good [“Chewing and swallowing as
`indices of the stimulation to eat during meals in humans:
`effects revealed by the edogram method and video record-
`ings.” Neurosci Biobehav Rev 24(2): 223-8]; in 1982 Kiss-
`ileff and Thornton showed that effecting behaviorat the start
`of a meal may determine how the rest of a meal is eaten
`[“Facilitation and inhibition in the cumulative food intake
`curve in man” Changing concepts of the nervous system. A.
`J. Morrison and P. Strick. New York, Academic Press:
`585-607); finally, in 1966, Jordan et al. demonstrated that the
`volume of material ingested just prior to a meal (“pre-load”)
`matters more than the caloric density of the pre-load, there-
`fore, drinking lots of water 15 minutes before a meal will
`reduce consumption (“Direct measurement offood intake in
`man: a method for the objective study of eating behavior.”
`Psychosom Med 28: 836-842).
`(OL01] These representative relationships between eating
`microstructure events and weight disorders prompted the
`present inventors to hypothesize that real-time biofeedback
`that
`is based on eating microstructure events could be
`utilized to monitor and modify human behavior and in
`particular eating behavior. As is shown in the Examples
`
`section which follows, the present inventors have demon-
`strated that eating microstructure events can indeed be
`utilized to accurately monitor the caloric intake of an
`individual.
`
`[0102] While reducing the present invention to practice,
`the present inventors devised an approach which can be used
`to monitor a behavior (e.g. eating behavior) of a subject and
`provide real time feedback for altering such behavior (e.g.
`alerting the subject when they are eating more than allowed
`by their diet plan or more than is required to maintain their
`desired weight). As is described herein, such an approach
`can be embodied by a system which can be worn by the user
`in a comfortable and concealed location on the body, or
`implanted subcutaneously by a simple, low-risk procedure.
`
`[0103] Thus, according to one aspectof the present inven-
`tion there is provided a method of monitoring and optionally
`modifying a behavior of a subject. The terms “subject” and
`“user” are interchangeably used