Project breakFAST:

Fueling Academics and Strengthening Teens

DATA COLLECTION

MANUAL OF PROCEDURES

December 23, 2014

Contents

1.Introduction

2.Measurement of Height, Weight, and Percent Body Fat

2.A Roles

2.B Equipment

2.C Training and Certification for Data Collectors

2.D Height, Weight and Percent Body Fat Data Collection

2.E Safety Considerations

2.E.1 Participant safety

2.E.2 Data safety

2.F Quality Control Procedures

2.F.1 Equipment

2.F.2 Measurements

2.G General Measurement Procedures

2.G.1 Measurement Stations

2.G.2 Privacy Considerations

2.G.3 Confidentiality Considerations

2.G.4 Clothing & Hairstyle

2.G.5 Introduction Script

2.H Measuring Height

2.I Measuring Weight

2.I.1 Using Tanita scale

2.I.2 Using the Seca scale

2.J Data Management at School Site

3.In-person Eligibility Screening

3.A Background

3.B Staffing and Roles

3.C Room Set-up:

3.D Screening and Consent Procedure

3.D.1. Eligibility script

3.D.2.Eligibility survey

3.D.3. Contact information and recall availability

3.E. Study packet

3.F Arranging for measurement of height, weight, and percent body fat

3.G Documentation and wrap-up activities

1.Introduction

“Project breakFAST: Fueling Academics and Strengthening Teens” is a four year intervention/control research project funded by the National Heart, Lung and Blood Institute. The Principal Investigator is Susie Nanney. The investigative team has partnered with 16 schools across rural Minnesota to carry out the goals of the project.

The primary goal of the project is to increase rural high school student participation in the School Breakfast Program (SBP) through increased access to the program. Students do not have to eat school breakfast to be a part of the research project.

A secondary goal of the project is to document a decrease in the rate of weight gain relative to height gain among students in the intervention condition as measured by change in body mass index and percent body fat. Height, weight and % body fat will be measuredfor all students participating in Project breakFAST.The measures will be taken during the school day with each participating student being released from class.

To evaluate the goals of the study, participating students will also complete a 10-minute online survey and three dietary recalls of what they ate/drank within the previous 24-hours.

All measurements will be done twice, and timing will depend on whether the school isparticipating in the first or second wave. Wave 1 schools are those sites participating in measures in the spring of 2013 (baseline) and the spring of 2014 (post-intervention). Wave 2 schools are those sites participating in measures in the spring of 2014 (baseline) and the spring of 2015 (post-intervention). Height, weight and % body fat will be measured a third time: spring of 2015 for wave 1 schools and spring of 2016 for wave 2 schools.

A Project breakFAST measurement team will go to each school to enroll students (baseline only) and collect measurementson two days.The team will collect height, weight, and body fat measurements on enrolled students, and will conduct in-person eligibility screening on “in process” students (baseline only). This manual details the procedures for both of these processes.

2.Measurement of Height, Weight, and Percent Body Fat

2.ARoles

Recorder: individual responsible for entering student data into the spreadsheet and identifying when a quality control measurement is to be taken.

Measurer: individual responsible for taking measurements of student height, weight and % body fat.

Team Lead: individual who will also have a role of Recorder or Measurer with additional responsibilities for set-up and quality control of equipment and measurements. Acts as the team’s representative when issues arise.

2.BEquipment

Please see Appendix A: Equipment Checklist

2.C Training and Certification for Data Collectors

All data collectors taking height, weight and percentbody fat measurements must be certified by successfully completing training requirements. Training and practice sessions will be conducted prior to certification.

Certification testing requires a minimum of fourindividuals to be measured by both the trainer (expert) and each training participant. Agreement between the expert and traineesmust be within 0.5 cm for height and 0.5 kg for weight and 2% for body fat. Data collectors who do not pass the certification test will have the opportunity for additional instruction and testing.

Recorders are not required to be certified to take the measurements, but should be completely familiar with the data collection forms, edit specifications and this Manual of Procedures.

2.DHeight, Weight and PercentBody Fat Data Collection

Height, weight and % body fat measures will be collected on a password protected Excel spreadsheet. The spreadsheet will be saved to two project specific laptops to be used only for study purposes. The spreadsheet has space to record two trials of each height, weight and % body fat measurement. A third trial is conducted for height, weight and % body fatwhen the first two trials do not meet the edit specifications of agreement, indicated under each section. The spreadsheet is set up to notify the Recorder that the first two trialsdiffer by an amount greater than the edit specification (>.2kg for weight,0.5 cm for height, and >2% for percent body fat)and that a third trial is needed. It is the responsibility of the Recorder to ensure that this accuracy is met.

The comment column of the spreadsheet should be used to note any observation or occurrence during data collection that the measurer thinks may have affected the actual measurement (irregularity,injury, disability, hairstyles, etc.) or to explain a missing measurement (student refusal, absenteeism, students with pace makers or other electronic medical devices).

A representative from Extension will be working with each school’s liaison to review the list of students enrolled in the study. They will schedule students for measurement times. The liaison will be asked to identify students who are not able to stand unassisted (for example a student who uses a wheelchair). Students identified as unable to stand unassisted will be exempted from measures. Prior to % body fat measurements, the measurer will ask the student if they have a pacemaker or any other medical device. Students who do will be asked to participate in height and weight measures but will be exempted from the % body fat measure.

See Appendix D for a list of “Frequently Asked Questions” and Appendix E for “What if…” scenarios.

2.ESafety Considerations

2.E.1 Participant safety

Both the Measurer and the Recorder should introduce themselves to the student and carefully explain all procedures to the student.

All equipment cords should be arranged in such a way to allow easy movement of staff and participants. The measurer shouldnot be wearing rings, bracelets or other jewelry that could pose a hazard during measurements. For the same reason they should not be holding pens or pencils while taking measurements.

If a participant has an irregularity or physical injury such that a measurement cannot be taken (for example a cast), the irregularity or injury should be noted on the data collection form on the comments section, and measurements should be made to the extent possible.

2.E.2 Data safety

It is the responsibility of the Recorder to be aware of the location of the laptop at all times.He/she is responsible for logging into the laptop and logging out of the laptop when it is not in use. If an emergent situation arises and the building needs to be evacuated the laptop should be taken with to the extent it is safe to do so. All other equipment should be left behind.

When sending the measurement spreadsheet back to the Database Manager via the internet, it should be sent ONLY through a protected source such as REDCap’s Send-It function.

2.FQuality Control Procedures

2.F.1Equipment

Scale calibration is required before measurements can begin. The Team Lead is responsible for calibrating the scale(s). The scalesare required to be calibrated at the beginning of the day and anytime they are moved. In the event that a Tanita scale is not in calibration a Seca scale will be used.

Calibration of the scale is obtained by placing a 5 pound (2.27 kg) weight on the scale; a scale that is off by more than 0.3 kg cannot be used. Calibration results are to be recorded onto the Scale Calibration log daily. See Appendix B. One log will contain the calibration history of all the scales in use. The Team Lead is responsible for logging the scale number and for monitoring the precision of the scales over the course of the study.A weight for clothing needs to be entered. Press the [Clothing] button and enter “.5kg” for clothing.

To turn paper dispensing off of the Tanita

  1. Press and HOLD the [0] key, and press the [ON/OFF] key once. Release the [0] key after “prt-1” is displayed on the screen.
  2. Select the desired number of print outs.
  3. Using the number keys, enter the quantity of print outs desired. As many as nine are possible. For NO print outs press the [0] key.

2.F.2 Measurements

If there is time, before measurements are taken, each Measurer is to practice taking measurements, with the Team Lead observing to ensure proper technique.

During the measurements, monitoring is ongoing by the Team Leader, who can provide corrective directions when deviations from protocol are observed.

To reduce errors that might be caused by measurer fatigue, team members (measurer and recorder) should switch positions every 5-10 students, with 10 students being the maximum amount of students that any one person measures in a row. Save the spreadsheet prior to switching positions.

Quality control (QC) data is collected at baseline by repeating measurements on ten percent of students per school in order to assess inter-observer reliability. When the Database Manager sets up a spreadsheet for a school, she will randomly select ten percent of enrolled students and 13-15% of in process students for a QC measure. (The over-selection of in process students is made to account for the fact that an estimated 23% of in process students will not enroll.) The randomly selected students will be identified in the database by a “1” in the “QC” column. These students will also be listed in an additional sheet of the spreadsheet, where their QC measurements should be recorded. The QC sheet can be opened using the “QC” tab at the bottom of the Excel document.

The repeat measurements will be collected by a different measurement staff member than the staff member who did the first set of measures. Only when the first set of measurements is completed should the Recorder let the student and Measurer know that the student will be measured again for QC.

After each measurement day, the project manager will compare the QC data with the original measures, using the averages of the repeat trials from the first and second measurer.The differences of the averages should match the edit specifications (<.2kg difference for weight,0.5 cmdifference for height, and 2% difference in body fat) of the measurement. If the QC measurements do not match the edit specifications, measurement staff will receive additional training.

2.GGeneral Measurement Procedures

2.G.1 Measurement Stations

Staff will be responsible for setting up their measurement station.The Tanita scale needs to be set up on a flat and stable surface (on top of the plywood square if floor is uneven) so that the bubble in the level on the scale is in the middle of the red circle. The stadiometer should be set up against a flat wall. Preferably these should be set up close enough so the student does not have to walk a far distance from one measurement to the next.

The Team Lead will be responsible for confirming correct set up and any necessary calibration (see 7.1).

2.G.2 Privacy Considerations

Each student being measured has the right to privacy. Even though the settings for these physical measures may be slightly different among schools, care should be given that the physical measures are taken in privacy. Privacy screens will be used for measurements when indicated.

2.G.3 Confidentiality Considerations

Each student being measured has the right to confidentiality. Every effort should be made to keep observations and data recording as objective and non-judgmental as possible. The staff should be pleasant and respectful to each student who participates in the study.

Communication among staff during measurements should be done in a quiet and respectful manner so that no one (participants, other students or school staff) can overhear any discussion related to results.

2.G.4 Clothing & Hairstyle

Students will be reminded, as we are able, prior to the measurement day that they are to dress in light clothing and not wear tights or nylon stockings.Students will be asked to remove their shoes and any excess clothing that they are comfortable removing(sweatshirts, sweaters, or jackets). The students will also be asked to remove any items from their pockets and temporarily place them in baskets provided.

For height measurements, students will be asked to remove their eyeglasses. If the subject has a hair accessory or hairstyle that interferes with the measurement, he/she will be asked to remove the accessory or change his/her hairstyle (e.g. take out ponytail band). If the subject refuses to comply with regard to hairstyle or accessory, then he/she will still be measured, and the measurer will make a note in the comment section of the data collection form.

2.G.5 Introduction Script

Both the Measurer and the Recorder should introduce themselves to the student and explain that they are going to: “take your height, weight, and body fat measurements. Each of these measurements will be done twice in a row (height, height; weight/body fat, weight/body fat) and possibly a third time so we can be sure we get a good reading.”

2.HMeasuring Height

“Please step back into the height board until some part of your body (heels, upper back, buttocks) touches the board and bring your feet together until your ankles or knees touch, whichever touch first. Stand straight up against the board. Your arms should be straight down at your sides, palms facing in and your weight evenly distributed on both feet.”

1)Check that they are properly aligned, both from front and from the right side.

2)Ask the student to tuck his/her chin (such that an imaginary horizontal line can be drawn between the bottom of eye socket and the opening of the ear – Frankfort Plane. See picture.)

“Please don’t move your head until we finish. Now, hold your head still, keep your feet flat, and take a deep breath and hold it.”

3)Verify body is properly aligned and head position did not shift with deep breath. Move the headboard onto the head with sufficient pressure to compress hair.

4)Read the measurement to the nearest 1mm to the Recorder.

5)Recorder restates the height at the time of data entry

6)The subject is asked to step away from the board, and the measurement is repeated as above.

7)If the two recorded measurements differ by more than 5 mm then a third trial must be measured and recorded.

2.IMeasuring Weight

2.I.1Using Tanita scale

1)Before the student steps on the scale, make sure that 0.0 appears on the screen. Also check that the scale is measuring in kg, (press the button that says “kg/lb” to change from lbs to kg) and that 0.5 kg has been entered for clothing.

“Now I will take your weight. Do you have a Pacemaker or any other electronic medical device?”

2)If yes, the participant cannot have his/her body fat measured. Instead, measure the participant’s weight using the Weight Only function on the Tanita. The body fat measure will be recorded as 999.9 (reflecting missing data) on the spreadsheet. The Recorder will need to make a note in the Comment section that the Weight Only feature of the Tanita was used to obtain the measurement and the reason why no body fat measurement was taken.

3)If no, continue with script.

“Please take off your socks and shoes. We need bare feet with this scale. Thishelps give us a good reading. The scales have been sanitized.”

4)BEFORE SUBJECT STEPS ON SCALE – Do not let participant stand on weighing platform when entering the following personal data (1-4):

  1. Enter Gender and Body Type (i.e., Standard Male, Standard Female) – Note that we will not use the Athletic body type

“What is your age?”

  1. Enter Age of subject; (16 years old= Press [1] [6])
  2. Enter Height using centimeters to the nearest whole number (e.g., 168.4 cm= Press [1] [6] [8]). (0.0-0.4 round down to 0.0; 0.5-0.9 round up to 1.0)
  3. When arrow appears next to [Step on], say:

“Please step onto the scale so that the backs of each of your feet are on one of the back circles/electrodes and so the fronts of your feet cover these front circles/electrodes. Make sure your weight is balanced between your two feet. Keep your hands at your sides and look straight ahead at the smiley face sign. (Note: the smiley face sign is in Appendix C) Measurer reads the weight after it stabilizes.