(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization
`International Bureau
`
`(43) International Publication Date
`31 May 2001 (31.05.2001)
`
` (10) International Publication Number
`
`WO 01/39089 A1
`
`(51) International Patent Classification7:
`
`G06F 17/60
`
`(21) International Application Number:
`
`PCT/US00/32331
`
`(22) International Filing Date:
`24 November 2000 (24.11.2000)
`
`(25) Filing Language:
`
`(26) Publication Language:
`
`English
`
`English
`
`(30) Priority Data:
`60/167,276
`60/177,011
`60/177,009
`60/177,016
`60/178,979
`60/194,126
`60/195,779
`60/200,428
`60/201,902
`
`24 November 1999 (24.11.1999)
`19 January 2000 (19.01.2000)
`19 January 2000 (19.01.2000)
`19 January 2000 (19.01.2000)
`28 January 2000 (28.01.2000)
`3 April 2000 (03.04.2000)
`10 April 2000 (10.04.2000)
`28 April 2000 (28.04.2000)
`4 May 2000 (04.05.2000)
`
`US
`US
`US
`US
`US
`US
`US
`US
`US
`
`60/207,051
`60/207,089
`60/209,921
`09/721,382
`
`25 May 2000 (25.05.2000) US
`25 May 2000 (25.05.2000) US
`7 June 2000 (07.06.2000) US
`22 November 2000 (22.11.2000) US
`
`(71) Applicant: HEALTHETECH, INC. [US/US]; Suite 120,
`433 Park Point Drive, Golden, CO 80401 (US).
`
`(72) Inventor: MAULT, James, R.; 1580 Blakomb Court, Ev-
`ergreen, CO 80439 (US).
`
`(74) Agents: WATHEN, Douglas, L. et al.; Gifford, Krass,
`Groh, Sprinkle, Anderson & Citkowski, PC, 280 N. Old
`Woodward Ave., Suite 400, Birmingham, MI 48009 (US).
`
`(81) Designated States (national): AL, AM, AT, AU, AZ, BA,
`BB, BG, BR, BY, CA, CH, CN, CU, CZ, DE, DK, EE, ES,
`FI, GB, GE, GH, GM, HR, HU, ID, IL, IS, JP, KE, KG, KP,
`KR, KZ, LC, LK, LR, LS, LT, LU, LV, MD, MG, MK, MN,
`MW, MX, NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK,
`SL, TJ, TM, TR, TT, UA, UG, UZ, VN, YU, ZW.
`
`[Continued on next page]
`
`(54) Title: HEALTH MANAGEMENT SYSTEM WITH CONNECTION TO REMOTE COMPUTER SYSTEM
`
`(57) Abstract: An improved health management system and
`method are described. A user is provided with a portable
`microprocessor—based device, which has an application program
`adapted to receive user input data (40-54) related to caloric
`intake and caloric expenditure. An application program on
`a remote computer receives the data and analyzes the data to
`provide feedback and advise the user.
`
`INPUT PERSONAL DETAILS:
`e.g. name, age, gender, password
`
`l'NI’UT START PARAMETERS
`weight, height, lifestyle activity level,
`RMR (if not measured, estimate)
`
`INPUT WEIGHT LOSS GOALS
`
`CALCULATE CALORIC EXPENDITURE (TEE)
`
`CALCULATE ALLOWED CALORIC INTAKE
`
`CALCULATE NUTRITIONAL BALANCE
`
`ADIUST ACTIVITY LEVELS
`
`CONFIRM INPUTS/EXIT SET UP
`
`40
`
`42
`
`46
`
`48
`
`50
`
`S2
`
`54
`
`
`
`WO01/39089A1||||||||||||||ll||||||||||||||||ll||||||||||||||||||||||||||||||||||||||||||||||
`
`1of70
`
`FITBIT EXHIBIT 1005
`
`1 of 70
`
`FITBIT EXHIBIT 1005
`
`

`
`WO 01/39089 A1
`
`||||||||||||||ll||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
`
`(84) Designated States (regional): ARIPO patent (GH, GM, — Before the expiration of the time limit for amending the
`KE, LS, MW, MZ, SD, SL, SZ, TZ, UG, ZW), Eurasian
`claims and to be republished in the event of receipt of
`patent (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), European
`amendments.
`patent (AT, BE, CH, CY, DE, DK, ES, FT, FR, GB, GR, IE,
`IT, LU, MC, NL, PT, SE, TR), OAPI patent (BF, BJ, CF,
`CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG).
`
`For two-letter codes and other abbreviations, refer to the "Guid-
`ance Notes on Codes andAbbreviations " appearing at the begin-
`ning ofeach regular issue ofthe PCT Gazette.
`
`Published:
`— With international search report.
`
`20f70
`
`2 of 70
`
`

`
`WO 01/39089
`
`PCT/US00/32331
`
`HEALTH MANAGEMENT SYSTEM WITH
`
`CONNECTION TO REMOTE COMPUTER SYSTEM
`
`Field of the Invention
`
`The invention relates to health management, in particular to diet management and
`
`weight control,
`
`Background of the Invention
`
`There are serious problems with conventional weight
`
`loss programs. Food
`
`consumption by the person using the weight loss program (the user) is conventionally
`recorded in great detail, allowing an accurate caloric intake to be determined. However,
`
`weight control is related to the user’s net caloric balance, the difference between caloric
`intake and caloric expenditure. Caloric expenditure is usually not known accurately. It is
`
`10
`
`possible to estimate the caloric expenditure related to various physical activities.
`
`However, as discussed by Remmereit in U.S. Patent No. 6,034,132, for a typical person,
`
`70 percent of total caloric expenditure is due to their resting metabolic rate (RMR). In a
`
`conventional diet program, RMR is estimated from the height, weight, age, and gender of
`
`the person, for example using the Harris-Benedict equation. This equation, well known to
`
`15
`
`those skilled in the nutritional arts, is given in U.S. Patent No. 5,839,901 to Karkanen,
`
`and in U.S. Patent No. 5,639,471 to Chait et al. There are serious inadequacies in using
`
`the Harris-Benedict equation (or any similar equation) in a’ weight loss program. The
`
`Harris-Benedict equation provides only an estimated RMR, which is an average value for
`
`3of70
`
`3 of 70
`
`

`
`WO 01/39089
`
`PCT/US00/32331
`
`-2-
`
`people of similar height, weight, age, and gender. However, due to natural variations in
`
`physiology, it need not be accurate for a specific individual.
`
`The total caloric expenditure of a person comprises a resting metabolic
`
`component and a physical activity component. Total energy expenditure (TEE) is the sum
`
`5
`
`of resting energy expenditure (REE) and activity energy expenditure (AEE), i.e. TEE =-
`AEE + REE. Weight loss occurs if total caloric expenditure (TEE) exceeds total caloric
`
`intake over a given time period. The net caloric ‘balance for a person is the difference
`
`between caloric expenditure and caloric intake.
`
`Conventional weight loss programs use an estimated TEE based on estimates of
`
`10
`
`activity levels, and estimates of REE from the Harris-Benedict equation. However, if
`
`REE is not estimated correctly, the person’s caloric balance cannot be known accurately,
`
`and the outcome of a weight loss program is likely to be unsatisfactory.
`
`It is also known that RMR often falls during a restricted calorie diet. The Harris-
`
`Benedict equation scales RMR with weight, but does not account for a natural slowing of
`
`15
`
`human metabolism in what the body may interpret as partial starvation conditions.
`
`Physical activity during the restricted calorie diet may cause RMR to fall further to allow
`
`the body to conserve energy, or, alternatively, it may cause RMR to increase due to an
`
`increase in muscle mass. Hence, in addition to unpredictable variations in RMR from
`
`person to person, there are also unpredictable changes in RMR in response to a weight
`
`20
`
`control program. The improved weight control system described herein overcomes these
`
`problems.
`
`4of70
`
`4 of 70
`
`

`
`WO 01/39089
`
`PCT/US00/32331
`
`-3-
`
`Resting metabolic rate‘ (RMR) can be measured using an indirect calorimeter.
`
`REE corresponds to the value RMR multiplied by an appropriate time period, usually one
`
`day. (RMR is a rate of energy expenditure whereas REE is a total energy expenditure
`over a given time period, though REE and RMR are sometimes used interchangeably).
`Conventional indirect Calorimeters are too large and expensive to be used as part of a
`
`5
`
`weight control program. Recently, James R. Mault M.D. et al. invented an improved
`
`indirect calorimeter, embodiments of which are well suited for applications in improved
`
`weight control and health management programs. The improved indirect calorimeter is
`
`more fully described in pending U.S. application Serial No. 09/630,398.
`
`10
`
`Conventional diet calculators enable food records to be created on a hand-held-
`
`device. However, they do not provide a link to a communications network, and so cannot
`
`provide feedback generated by a remote computer system, or health professional with
`
`access to the communications network.
`‘In U.S_. Patent No. 3,839,901, Karkanen describes an integrated weight
`
`loss
`
`15
`
`control method, in which a calorie density is determined by comparing the actual weight
`
`loss of a dieter to an estimated calorie deficit. This patent does not describe a system in_
`
`which a person has a portable computing device linked to a communications network.
`
`In U.S. Patent No. 5,639,471, Chait et al. describes the formulation of a
`
`nutritionally balanced diet based on a person’s caloric requirements calculated using the
`
`20
`
`Harris-Benedict equation. However, this patent does not describe a weight loss program
`
`with feedback provided to the person over a communications network, or
`
`the
`
`determination of a person’s caloric balance.
`
`5of70
`
`5 of 70
`
`

`
`W0 01/39039
`
`PCT/US00/32331
`
`-4-
`
`In U.S. Patent No. 5,933,136, Brown describes the controlled access to an
`
`entertainment program based on the user’s compliance with a treatment plan. However,
`
`this patent does not describe the provision of information so as to help the user comply
`with a weight control program, based on the degree of compliance with the program.
`
`5
`
`In U.S. Patent No. 6,039,688, Douglas et al. describes a therapeutic behavior
`
`modification program. However, this patent does not describe the determination of a
`
`person’s caloric balance.
`
`In U.S. Patent No. 4,321,674, Krames describes an electronic diet calculator.
`This hand-held device allows a person to record consumption from a limited selection of
`
`10
`
`food items.
`In U.S.'Patent No. 4,729,479, Duboff describes a diet calculator with key
`entry,
`in which consumption is subtracted from target amounts. In U.S. PatentNos.
`
`5,704,350 and 4,891,756, Williams et al. describes a diet calculator in which foods are
`
`grouped by category, and presented to the user using a menu display.
`
`In U.S. Patent No.
`
`5,729,479, Golan describes a multifunctional diet calculator, in which cumulative food
`
`15
`
`totals are compared with target amounts. Other diet calculators are described by Sakai
`
`(4,855,945), Ikemoto (4,894,793), and others.
`
`Summary of the Invention
`
`It is an object of the present invention to provide an improved weight control
`
`system. In a preferred embodiment,
`
`the person using the improved weight control
`
`20
`
`program (the user) is provided with a portable computing device, such as a personal
`
`digital assistant (PDA). The PDA has a software application program, which for
`
`6of70
`
`6 of 70
`
`

`
`WO 01/39089
`
`PCT/US00/32331
`
`-5-
`
`convenience will be called a calorie management program. The calorie management
`
`program comprises the functionality of diet logging software, and enables the user to
`
`record food items consumed. The calorie management program preferably has other
`
`functionality, so as to assist the user to set and achieve weight goals.
`
`5
`
`Another object of the invention is to provide a weight control system in which
`
`unpredictable. variations of resting metabolic rate (RMR) are accounted for. The user
`
`preferably measures their
`
`using a metabolic rate meter, such as an indirect
`
`calorimeter, and enters this value into the calorie management program. The user also
`
`enters weight control goals, such as a certain weight loss goal. The calorie management
`
`10
`
`program uses the determined value of RMR to estimate total energy expenditure (TEE),
`
`based on an assumed level of physical activity, and determines a level of caloric intake _
`
`which will enable the weight control goals to be met. During the weight control program,
`
`the user records weight, food intake using a diet log, activity levels, and resting metabolic
`
`rate at intervals.
`
`15
`
`A further object of the invention is to provide improved feedback to the user over
`
`a communications network. Calorie management data is transmitted from the PDA to the
`
`remote computer system. The user connects to the remote server at a convenient time, for
`
`example in the evening, and recorded dietvlog data, weight, and activity-related signals
`
`are transmitted to the remote server and stored in a related database. Feedback is
`
`20
`
`generated by the remote computer system, - and transmitted back to the portable
`
`computing device of the user.
`
`7of70
`
`7 of 70
`
`

`
`WO 01/39089
`
`PCT/US00/32331
`
`-5-
`
`Brief Description of the Drawings
`
`Figure 1A illustrates a portable computing device;
`
`Figure 1B illustrates a system embodiment of the invention;
`
`Figure 2 is illustrates a set-up procedure for a user of calorie management
`
`5
`
`software;
`
`Figure 3 shows a menu screen on the display of a portable computer, from which
`
`I a user selects a food iteih;
`
`Figure 4 illustrates the interactions between a portable computing device and a
`
`remote computer over a communications network;
`
`10
`
`Figure 5 is a schematic showing communication between a portable computer and
`
`a‘ remote computer system;
`
`Figure 6 is a schematic showing a community of users interacting with a remote
`
`computer system;
`
`Figure 7 is a schematic illustrating controlled user access to a data relating to a
`
`15
`
`community of users;
`
`Figure 8 shows a person breathing through an indirect calorimeter;
`
`Figure 9 shows a cross—section of an indirect calorimeter, suitable for use in
`
`embodiments of the prdsent invention;
`
`Figure 10 is a schematic of a weight control system including an ‘indirect
`
`20
`
`calorimeter;
`
`Figure 11 is a schematic of a weight control system comprising a portable
`
`computer which interfaces with a desktop computer;
`
`8of70
`
`8 of 70
`
`

`
`WO 01/39089
`
`PCT/US00/32331
`
`-7-
`
`Figure 12 is a‘ schematic of a weight control system in which an indirect
`
`calorimeter is located at a physician’s office;
`
`Figure 13 is a schematic of a system in which food data is received during a
`
`purchase transaction;
`
`5
`
`Figure 14 shows a wrist-mounted device used in embodiments of the present
`
`invention; and
`
`Figure 15 shows a system embodiment using a wrist-mounted device.
`
`Detailed Description of the Invention
`
`Figure 1A shows a handheld-microprocessor-based device 10, used in preferred
`
`10
`
`embodiments of the present invention, having a user display 12 and a user information
`
`input in the form of data entry buttons 14. The device 10 is a portable computing device,
`
`preferably a personal digital assistant (PDA), but it can also be a wireless phone, an
`electronic book, a pager, other portable computer, or other portable electronic device
`
`having computational functionality. For convenience, portable computing device 10 will
`
`15
`
`be hereinafter referred to as a PDA,
`
`though this is non-limiting as other portable
`
`computing devices can be used. The user may also input data into the PDA using a
`
`stylus, bar-code reader, finger motion detector, voice recognition method, track ball, or
`
`any other convenient input method. The PDA has a data transmission and reception
`
`means for transmitting data to (and receiving data from) a communications network, for
`
`20
`
`example; a telephone modem, wireless modem, cable modem, network interface card, or
`
`other
`
`telecommunication transceiver. Preferably,
`
`the PDA is connected to the
`
`9of70
`
`9 of 70
`
`

`
`WO 01/39089
`
`PCT/US00/32331
`
`-3-
`
`communications network using a wireless connection, but cables, optical fibers, and other
`
`systems may also be used.
`
`Figure 1B is a schematic of an improved diet control system. Portable computing
`
`device 10 is connected to a communications network 20. A remote computer system 30
`
`is also connected to the communications network, so as to allow data to be transmitted
`
`between the computing device 10 and the remote computer system 30 over the
`
`communications network 20. The communications network provides a communications
`
`link between devices connected to the communications network. The portable computing
`
`device 10 also receives data from a physical activity sensor 16, and body weight scales
`
`18. The portable computing device also can communicate with a computer 22, the
`
`computer 22 also being connected to the communications network 20.
`
`The communications network 20 is preferably‘ a public network adapted to receive
`
`data from the PDA, such as digital representations of data stored in the memory of PDA
`
`10. The communications network 20 is preferably the Internet. The connection between
`
`the PDA. 10 and the communications network 20 is preferably a wireless connection, such
`
`as a wireless Internet connection, however cables, phone lines, optical fibers and other
`
`communication links can also be used.
`
`The remote computer system 30 is preferably a server" system. The remote
`computer 30 is connected to the network 20, and is adapted to receizveldata from the PDA
`such as digital representations of data stored in the memory of PDA 10. The remote
`
`computer 30 has an application program for analyzing the user's caloric consumption,
`
`caloric expenditure, and net caloric balance, and for generating feedback (such as critical
`
`10
`
`15
`
`20
`
`10 of70
`
`10 of 70
`
`

`
`WO 01/39089
`
`PCT/US00/32331
`
`-9-
`
`messages, other advice, educational content, and the like) to the user, the messages and
`
`feedback relating to the user's progress toward a weight control goal. The remote
`
`computer 30 also has transmission circuitry for transmitting messages and feedback over
`
`the network 20 to the PDA 10. The messages and feedback act to motivate the user to
`
`5
`
`make progress towards a weight control goal.
`
`One system embodiment requires only PDA 10, communications network 20,
`
`scales 18, and remote computer system 30. This embodiment will be discussed first, and
`
`other systems including the activity sensor 16 and computer 22 are discussed later.
`
`The PDA 10 has a software application program so as to assist the user to set and
`
`10
`
`achieve weight goals. The program is adapted to receive user inputs related to user
`
`caloric intake and user‘ caloric expenditure and to calculate user net caloric balance on a
`
`daily basis. For convenience, this program running on the PDA 10 will be called a
`
`calorie management _ program. The calorie management program comprises
`
`the
`
`functionality of diet
`
`logging software, and enables the user to record food items
`
`15
`
`consumed. The PDA has a memory for storing user inputs related to caloric intake and
`
`caloric expenditure, and a transmission means for providing digital representations of the
`
`information stored in the memory.
`
`Diet logging software suitable for adaptation for use in the present invention has
`
`been described in U.S. provisional application Serial No. 60/240,185, incorporated herein
`
`20
`
`in its entirety by reference. Diet logging software is also described in U.S. Patent Nos.
`
`5,704,350 and 4,891,756 to Williams, incorporated herein in their entirety by reference.
`
`A calorie management program running on the PDA allows the user to record food
`
`11 of70
`
`11 of 70
`
`

`
`WO 01/39089
`
`PCT/US00/32331
`
`-10-
`
`intake, hence determining their caloric intake. Preferably, a database of food and drink
`
`items and associated nutritional data (such as caloric values) is stored on the PDA, and
`
`accessed by the calorie management software to correlate food identities with nutritional
`
`data. Alternatively, a database of food identities, and associated nutritional data can also
`
`5
`
`be located on the remote computer system 30. The remote database would preferably be
`
`more extensive, so as to allow expansion of the local database on the PDA as needed.
`
`Before the start of the weight control program, the user completes a set-up
`
`. procedure. Figure 2 illustrates an example set-up procedure which the user completes
`
`before starting a weiglit control program. Boxes 40-54 in Figure 2 represent functional
`
`10
`
`steps provided by the calorie management software running on the PDA 10.
`
`The user enters personal information (box 40), such as their name, alias, e-mail
`
`address, and a password. This information is usedfor communication with the user, and
`
`sharing data with other users, and other authorized persons such as health management
`
`workers. This step is only executed on the user’s first use of the software, or if personal
`
`15
`
`, details change. Calorie management software on a single portable device such as 10 may
`
`support multiple users, for example through different password entry.
`
`The user enters start parameters (box 42), such as starting date, initial weight, age,
`
`height, body fat percentage,
`
`lifestyle activity level, and frame size. If required, the
`
`software can present a comparison of the user’s current weight and body mass index
`
`20
`
`against accepted healthy ranges. The user also enters lifestyle information, such as
`
`occupation, physical activity levels, time at work, and time asleep. This information is
`
`used to estimate a value for activity energy expenditure AEE.
`
`12 of70
`
`12 of 70
`
`

`
`WO 01/39089
`
`PCT/US00/32331
`
`-11-
`
`Preferably, the user determines their initial resting metabolicl: rate (RMR) using an
`
`indirect calorimeter, and enters this value into the calorie management software. The use
`
`of an indirect calorimeter in an improved weight control system is described in more
`
`detail later. If the user does not know their RMR, and an indirect calorimeter is not
`
`available, the Harris-Benedict equation is used to estimate the RMR of the user. This
`
`equation is described in U.S. Patent No. 5,839,901 to Karkanen, incorporated herein in its
`
`entirety by reference. However, it is important to note that the Harris—Benedict equation
`
`provides. only an estimate of metabolic rate.
`
`(This estimate ‘can be improved by
`
`determination of body fat content, for example using bioelectrical impedance analysis.)
`
`10
`
`The software may display the daily values of REE, AEE (as determined from lifestyle
`
`activity data), and TEE to the user at this point.
`
`The user then enters their goal or goals (box 44), such as aweight goal (weight
`loss, weight gain, or weight maintenance),,fat loss, muscle building, blood pressure
`reduction, blood sugar control, and the like. In this specification, for convenience, we will
`consider the case of a user wishing to lose weight.
`In this case, the user enters weight
`
`15
`
`loss goals, such as a total weight loss over a time period, or a desired weight loss rate (for
`
`example one pound per week).
`
`The software determines a caloric intake level consistentigfwith the weight loss
`
`goals (box 48). For weight loss, the caloric intake needs to be lower than TEE, lie. the
`
`20
`
`user’s net caloric balance is negative and the user experiences a calbrie deficit. The user’s
`
`weight loss is related to the negative caloric balance (calorie deficit) via a parameter
`
`termed the calorie density. As discussed by Karkanen in U.S. Patent No. 5,839,901, a
`
`13 of70
`
`13 of 70
`
`

`
`WO 01/39089
`
`PCT/US00/32331
`
`-12-
`
`calorie density of 3500 Cal/lb is conventionally used to predict weight loss from the
`
`calorie deficit. This implies that a calorie deficit of 3500 Cal/week is needed to lose one
`
`pound of body weight per week. The nutritional balance of consumed foods (the actual
`
`mix of carbohydrates, protein, and fat consumed, or planned to be consumed) recorded by
`
`the calorie management software can be used to determine a more accurate value for the
`
`calorie density. (The term calorie density is also used in the nutritional literature to refer
`
`to the calorie content per unit weight of food items. In this specification, the term calorie
`
`density is not used in this way, here calorie density refers to the relationship between
`
`caloric balance and body weight changes.) The software estimates an activity level and
`
`10.
`
`corresponding to AEE in calculating TEE, and hence the allowed caloric intake of the
`
`user.
`
`Using conventional nutritional knowledge, a recommended nutritional balance is
`
`provided consistent with caloric intake goals (box 50). Dietary guidelines are well known
`
`to those skilled in the nutritionaliarts. The implementation of diet guidelines in preparing
`
`15
`
`a balanced diet program within caloric limits, such as calculated using the Harris-
`
`Benedict equation, is "discussed in U.S. Patent No. 5,639,471 to Chait et al., incorporated
`herein in its entirety by reference. The calorie management software can be used in meal
`
`planning. The user can enter dietary restrictions, for example allergens, and other foods to
`
`be avoided, so as to exclude foods -from a planned diet program. Preferred foods can also ’
`
`20
`
`be entered, for example. a particular favored breakfast can be entered.
`
`The user is offered the possibility of changing the activity_ level, which changes ._'i
`
`' AEE and henceithe allowed caloric intake (box 52). For example, a user might prefer to 1
`
`l4 of70
`
`14 of 70
`
`

`
`WO 01/39089
`
`PCT/US00/32331
`
`-13-
`
`exercise more and eat more, while still remaining within a plarmed calorie deficit. After
`
`such changes, allowed caloric intake calculations ‘(box 48) and nutritional advice
`
`calculations (box 50) are repeated. The user then exits the set-up procedure, after
`
`confirming the accuracy of entered parameters (box 54), and can then start the weight
`
`5
`
`control program.
`
`During the weight control program, the user enters their diet log details into .the
`
`PDA. As food items are entered into the calorie management software,
`
`the actual
`
`nutritional balance of consumed foods can be compared with target nutrition goals.
`
`Nutritional supplements or food alternatives are suggested if the diet
`
`log shows a
`
`10
`
`nutritional imbalance. The calorie management software is adapted to receive user weight
`
`data at intervals, for "example user weight as determined daily using scales 18. The calorie
`
`management software is also adapted to receive data relating to the user’s resting
`
`metabolicurate, for example as determined using an indirect calorimeter. The use of an
`
`indirect calorimeter in an improved weight control system is described in more detail
`
`15
`
`later.
`
`{
`
`Preferably, the;'user selects food items consumed from a menu system presented
`
`on the display 12 of the portable computing device 10, for example as described in U.S.
`
`Patent Nos. 5,704,850 and 4,891,756 to Williams et al., and in co-pending U.S.
`
`provisional application_ASerial'No. 60/240,185. Figure 3 shows an example menu screen
`
`20
`
`display from which the user can select food items from within groups.
`
`15 of70
`
`15 of 70
`
`

`
`WO 01/39089
`
`PCT/US00/32331
`
`-14-
`
`If a particular meal is selected a number of times, it can be identified as a favorite
`
`by the software and presented to the user more prominently, for example at the top of a
`
`menu display.
`
`The PDA is used to record and display caloric intake and caloric expenditure.
`
`5
`
`The data may be presented as a running total in terms. of caloric balance, or on a daily
`
`basis, indicating the days on which caloric balance goals were achieved.
`
`The PDA can be used to record informal calorie management data, such as voice
`memos, images, notes, barcodes, or purchase information, and such informal data can be
`
`used to construct a full diet log at a later convenient time, using calorie management
`I
`
`10
`
`software running either‘ on the PDA or on the remote computer system.
`
`Preferably, the calorie management software running on PDA 10 receives data
`
`related to the physical activity level of the user. The user can enter the time, duration, and
`
`intensity of exercises or other activities into the calorie management software. Preferably,
`
`the PDA provides a menu of activities to the user and the user chooses an activity and
`
`15
`
`enters a duration.
`
`A button on the PDA 10, activity monitor 16, or other portable electronic device
`
`can be pressed at the beginning and end of an exercise to provide time and duration data.
`
`These time stamps can be used at a later time -in creation of a detailed exercise log. Voice
`
`memos can also be recorded using an optical imaging sensor, for example to record an
`
`20
`
`image to assist the user or other person to create an exercise log. The PDA may have an
`
`imaging functionality,‘or another device—may be used. For example, if an image of an
`
`16 of70
`
`16 of 70
`
`

`
`WO 01/39089
`
`PCT/US00/32331
`
`-15-
`
`exercise machine is recorded along with time of day and duration data, this will assist in
`
`the creation of a full exercise log at a later more convenient time.
`
`The user preferably carries a physical activity monitor 16 which provides a signal
`
`related to physical activity, and preferably this is a body mounted pedometer comprising
`
`5
`
`one or more accelerometers. Other types of activity monitors may be used, for example
`
`GPS-based monitors as described in U.S. patent applications Serial Nos. 6,148,262 and
`
`6,002,982 to Fry. Physicalactivity monitors providing a signal correlated with one or
`
`more physiological parameters,
`
`such as heart
`
`rate, body temperature,
`
`respiration
`
`frequency, and the like can also be used in system embodiments.
`
`l0
`
`2
`
`Data can be transferred from the activity monitor 16 to the PDA 10 using a cable
`
`link, wireless methods (such as the Bluetooth protocol or an IR link), using the transfer of
`
`memory modules, or by the formation of a data transfer interface between monitor 16 and
`
`PDA 10. The calorie management software on PDA 10 receives any such activity-related
`
`data, and processes the data so as to provide an estimate of activity related data (AEE).
`
`15
`
`Heart rate and other physiological parameters can also be monitored to provide a
`
`signal related to physical activity. The PDA can receive data from other physiological
`
`monitors, for example scales, a body fat meter, a pulse rate meter, a body temperature
`
`sensor, and the like. The PDA can also be used to predict blood sugar levels of the
`
`person based on the glycemic index of the foods consumed and activities planned. Meals
`
`20
`
`can be planned to avoid blood sugar levels outside of an acceptable range. The activity
`
`sensor 16 may possess additional functionality so as to act as a physiological monitor,
`
`physical location monitor, or environmental monitor.
`
`17 of70
`
`17 of 70
`
`

`
`WO 01/39089
`
`PCT/US00/32331
`
`-16-
`
`At intervals, data is transmitted between the PDA 10 and remote computer system
`
`30 over the communications network’ 20. Figure 4 illustrates an example interaction with
`
`the remote computer system. Boxes 60-70 represent functional steps.
`
`The user initiates connection with the remote computer system (box 60), for
`
`5
`
`example by logging- in to a web-site provided by the remote computer system.
`
`Connections can also be initiated automatically at intervals.
`
`The PDA 10 and remote computer system (server system 30) then enter aidata
`
`synchronization step (box 62). Data recorded by‘ the calorie management program, and
`stored in the memory of PDA 10, is transmitted to the remote computer system 30. This
`
`10
`
`includes data related to caloric intake,
`
`the most recent weight of the user, physical
`
`activity data, and metabolic rate data (if available). A software program running on the
`
`remote computer system 30 (server software) receives the data and stores the newly
`
`receive data on a database, where it is accessible by the server software.
`
`The received data and cumulative stored data are "processed by the server software
`
`15
`
`(box 66), so as to analyze the data in relation to user goals. The server software provides
`
`feedback to the user corresponding to the data analysis (box 68). Data analysis and
`
`feedback are discussed in more detail below.
`
`The server software can present data to the user graphically. The server generates
`
`visual presentations of data, for example by dynamic generation of a website, The PDA
`
`20
`
`is used to display the website to the user by the communications network. The website
`
`can be password protected, or otherwise onlylaccessible to the user and other authorized
`
`people.
`
`18 of70
`
`18 of 70
`
`

`
`WO 01/39089
`
`PCT/US00/32331
`
`-17-
`
`The user disconnects from the remote computer system (box 70) after data
`
`transfer steps are complete, and the user no longer wishes to view data representations
`
`generated by the server software. Feedback andcritical messages generated by the server
`
`may be stored in the memory of the PDA 10, where they can be viewed later.
`
`Figure 5 shows a further schematic of one example of how the user can
`
`communicate with the remote computer. Figure 5 shows an application program, running
`
`on remote computer system 30, in communication with a database 82, a source of dietary
`
`feedback 84, and a communications interface 86, preferably a web-site based interface.
`
`For example, the user’s identity and password can be embedded in a URL provided to the
`
`10
`
`server software. The user’s PDA can communicate with the application program 80 via
`
`the web-site 86 over the communications network 20.
`
`The user uses PDA 10 to connect
`
`to communication network 20. The user
`
`accesses a web site 86,§providing a name and password which is passed to server program
`
`80. Server program 80,recognizes the user. A synchronization step is performed, whereby
`user-related data stored on the PDA and in database 82 are compared, and in the case of
`
`15
`
`inconsistencies