Modifications to Questions
Rationale: Splitting Question 2 on the Home Tap Water Questionnaire into four parts will reduce unnecessary water collection and in testing did not increase the average time burden on pilot testing as most participants do not use water softeners or water filtration systems.
Att 10A1_Home Tap Water Questionnaire: Split question 2 (1 question) into two questions each with a sub-question among those responding affirmatively (4 total questions).
Previously Approved Question |
Proposed Questions and Rationale |
2.) Do you have a water softener or water filtration system in your home/apartment? YES……………..........……………………….1 NO…………………….........…………………2 REFUSED………………........................7 DON’T KNOW………………….........................9
|
Rationale: Splitting question 2 into four parts will reduce unnecessary water collection and in testing did not increase the time burden on pilot testing as most participants do not use water softeners or water filtration systems.
2.) Do you have a water softener in your home/apartment? YES…………….............................…………………………………………….1 NO……………..……………….......................................…………………2 REFUSED……….……………………………..........................................7 DON’T KNOW…………………………………………….......................................9
|
Rationale: Water softeners are usually only installed for the bathroom and laundry. Thus, drinking water is usually unaffected. With this modification, only water affected by water softeners will be collected.
If YES to 2.): 2.1) Is your kitchen/drinking water softened? YES……………...............................…………………………………………….1 NO……………………..………….......................................…………………2 REFUSED…………… ………………………….........................................7 DON’T KNOW……………………………………………........................................9
|
|
Rationale: Splitting question 2 into four parts will reduce unnecessary water collection and in testing did not increase the time burden on pilot testing as most participants do not use water softeners or water filtration systems.
3.) Do you have a water filtration system in your home/apartment? YES……………....................................…………………………………….1 NO………………………………………..............................…………………2 REFUSED………………………………………………................................7 DON’T KNOW…………………………………………….......................................9
|
|
Rationale: Water filtration does not affect sodium content unless the water filtration system is “reverse osmosis.”
If YES to 3.): 2.1) Is it a reverse osmosis system? YES……………...............................…………………………………………….1 NO……………………..………….......................................…………………2 REFUSED…………… ………………………….........................................7 DON’T KNOW……………………………………………........................................9
|
Att 13A_Duplicate Salt Sample Collection Form (Non Sub Study Participants)
Rationale: The information on this form will be recorded on the duplicate salt collection baggie labels by the participant (except as noted below). Recording this information on the baggie will keep the burden within the time frame (10 minutes per day collected) indicated on the original Information Collection Request and ensure that the data collected corresponds with the salt sample collected.
Previously Approved Questions |
Proposed Modification |
Part 1: Table Salt Collection
Date of salt collection: __________________
|
The Clinic Manager will record the date on the salt baggie label “Att 13A1_Bag Label Salt Added at the Table” for each day duplicate table salt collection is scheduled.
Date: _______________________ |
Type of salt in the salt shaker you are using at the table:
O Ordinary salt including sea salt, iodized salt, non-iodized salt, and kosher salt O Lite salt- brand name:__________________ O Salt substitute- brand name:_____________ O Other-describe:_______________________ O Don’t know O Not applicable (didn’t add salt to food at the table at home)
|
Participants are instructed to record the information on the salt baggie labels for each day table salt is used (see below). Type of salt is defined on Att 13C Duplicate Salt Sample Collection Instructions for Participants (Non Sub Study).
Type of Salt Added: (Choose One) Regular/ “Study Salt”/ Other:____________ I did not add salt at the table today. |
Record the following information about each meal or snack you added salt to food at the table (leave blank if you did not add any salt to food at the table)
Meal Name (e.g. lunch, snack) Approximate Time Food(s) salt was added to |
The questions about what food(s) the participant added salt to at the table will be eliminated. This information is not required to estimate the amount of sodium consumed from salt added at the table. |
Part 2. Salt Added in Home Cooking
Date of salt collection: __________________
|
Participants are instructed to record the date on the salt baggie labels “Att 14A1_Bag Label Salt Added in Food Preparation” each time salt is used in food preparation.
Date: _________________________ |
Type of salt you are using at home in cooking: O Ordinary salt including sea salt, iodized salt, non-iodized salt, and kosher salt O Lite salt- brand name:__________________ O Salt substitute- brand name:_____________ O Other-describe:_______________________ O Don’t know O Not applicable (didn’t add salt to food during home cooking)
|
Participants are instructed to record the information on the salt baggie label “Att 14A1_Bag Label Salt Added in Food Preparation” each time salt is used in food preparation (see below). Type of salt is defined on Att 13C Duplicate Salt Sample Collection Instructions for Participants (Non Sub Study).
Type of Salt Added: (Circle One) Regular/ “Study Salt”/ Other:____________
|
Record the following information about each meal or snack you added salt to food at the table (leave blank if you did not add any salt to food at the table)
Meal Name (e.g. lunch, snack) Approximate Time Food(s) salt was added to |
Participants are instructed to record the food item to which salt was added on the salt baggie label “Att 14A1_Bag Label Salt Added in Food Preparation” each time salt is used in food preparation. The participant will be asked details about the meal during the 24-hour dietary recall. This information is necessary to estimate the amount of discretionary salt added during home cooking (i.e., not during commercial processing).
Food Item: ___________________________ |
Att 14A_Duplicate Salt Sample Collection Form (Sub Study Participants) -
Rationale (Same as Att 13A): The information on this form will be recorded on the duplicate salt collection baggie labels by the participant (except as noted below). Recording this information on the baggie will keep the burden within the time frame (10 minutes per day collected) indicated on the original Information Collection Request and ensure that the data collected corresponds with the salt sample collected.
Previously Approved Questions |
Proposed Modification |
Part 1: Table Salt Collection
Date of salt collection: __________________
|
The clinic manager will record the date on the salt baggie label “Att 13A1_Bag Label Salt Added at the Table” for each day duplicate table salt is scheduled.
Date: _______________________ |
Was the study provided salt used at home during cooking? O Yes O No, did not use study salt O No, did not add salt to food at the table |
Participants are instructed to record the type of salt on the salt baggie labels for each day table salt is used (see below).
Type of Salt Added: (Circle One) Regular/ “Study Salt”/ Other:____________ I did not add salt at the table today. |
If “no, did not use study salt”, what type of salt was used at the table?
O Ordinary salt including sea salt, iodized salt, non-iodized salt, and kosher salt O Lite salt- brand name:__________________ O Salt substitute- brand name:_____________ O Other-describe:_______________________ O Don’t know
|
Participants are instructed to record the information on the salt baggie labels for each day table salt is used, including writing the name of the “Other” salt if not “regular” salt (see below and Att 17B_Study Salt Instructions for Participants). Regular salt includes sea salt, iodized salt, non-iodized salt, and kosher salt.
Type of Salt Added: (Circle One) Regular/ “Study Salt”/ Other:____________ I did not add salt at the table today. |
Record the following information about each meal or snack you added salt to food at the table (leave blank if you did not add any salt to food at the table)
Meal Name (e.g. lunch, snack) Approximate Time Food(s) salt was added to |
The question about what food(s) the participant added salt to at the table will be eliminated. This information is not required to estimate the amount of sodium consumed from salt added at the table. |
Part 2: Salt Added in Home Cooking
Date of salt collection: __________________
|
Participants are instructed to record the information on the salt baggie labels “Att 14A1_Bag Label Salt Added in Food Preparation” each time salt is used in food preparation. Date: _________________________ |
Was the study provided salt used at home during cooking? O Yes O No, did not use study salt O No, did not add salt to food at the table |
Participants are instructed to record the following information on the salt baggie label “Att 14A1_Bag Label Salt Added in Food Preparation” each time salt is used in food preparation (see below).
Type of Salt Added: (Circle One) Regular/ “Study Salt”/ Other:____________ |
If “No did not use study salt”, what type of salt was used while cooking? O Ordinary salt including sea salt, iodized salt, non-iodized salt, and kosher salt O Lite salt- brand name:__________________ O Salt substitute- brand name:_____________ O Other-describe:_______________________ O Don’t know O Not applicable (didn’t add salt to food at the table at home)
|
Participants are instructed to record the information on the salt baggie label “Salt Added in Food Preparation” each time salt is used in food preparation including writing the name of the “Other” salt if not “regular” salt (see below and Att 17B_Study Salt Instructions for Participants). Regular salt includes sea salt, iodized salt, non-iodized salt, and kosher salt.
Type of Salt Added: (Circle One) Regular/ “Study Salt”/ Other:____________ |
Record the following information about each meal or snack you added salt to food at the table (leave blank if you did not add any salt to food at the table)
Meal Name (e.g. lunch, snack) Approximate Time Food(s) salt was added to |
Participants are instructed to record the food item to which salt was added on the salt baggie label “Att 14A1_Bag Label Salt Added in Food Preparation” each time salt is used in food preparation. The participants are asked details about the meal during the 24-hour dietary recall. This information is necessary to estimate the amount of discretionary salt added during home cooking (i.e., not during commercial processing). |
Changes and clarifications in instructions and/or procedures to simplify information collection
Att 4A_ Telephone Recruitment and Screening Script
Rationale: The amount of home tap water that needs to be collected is larger than previously thought (~120 ml vs. 10 ml). As initially planned, this complicated procedures. Thus, the Home Tap Water Questionnaire will be administered at the end of the telephone recruitment and screening rather than at the initial visit and the participant will be asked to bring a sample of home tap water with them to the initial visit. Additional clarifications and their rationale listed below.
Modification |
Rationale |
Added the following instructions to the clinic manager: “IF THE PERSON IS ELIGIBLE AND SCHEDULES A CLINIC VISIT, ADMINISTER THE HOME TAP WATER QUESTIONNAIRE TO DETERMINE IF THEY SHOULD BRING IN A WATER SAMPLE.”
|
The home tap water questionnaire will be administered at the end of telephone recruitment after the person schedules a clinic visit rather than at the initial visit to save costs related to mailing water specimens: The amount of water required for analysis is about 1/2 cup (~120 ml) which is much greater than previously expected (10 ml). |
Information regarding urine collection deleted from the form. |
Participants who are not in the Sub Study will not be collecting urine.
|
The following sentence “Three of these days must be weekdays and one must be a weekend day” will be added after “The day prior to each telephone interview participants will be asked to collect samples of all the salt they add to food in home cooking and at the table.” |
To clarify participant expectations and increase adherence to study procedures
|
Deleted the phrase “and I’ll mail you a written description of the study and a consent form to read before the visit” |
All of the piloted participants scheduled an initial clinic visit within 5 days of the telephone call, most the next day. The participants receive the study description and consent form at the initial visit. The consent form will be read to the participant and any questions answered. |
Att 8 Study Orientation for Non-Sub Study Participants – modification of text
Rationale: On Att 8 and Att 9, the text orienting participants to the study components has been modified so that all of the study components are described on these forms and reviewed by the study manager. The participants are then provided written copies of the corresponding information collection forms and instructions for review at home. In addition, the scheduling for the dietary recall which was a part of this form will now be collected on a separate form (Att 8a) to be sent to the University of Minnesota Nutrition Coordination Center.
Modification (in red as applicable) |
Rationale |
Deleted information on urine collection. |
According the approved ICR for 0920-0982, Non Sub Study Participants will not collect urine. |
The following sentence “One of these days must be a weekend day; the other three will be weekdays” will be added. |
See Att_4A: Screening and Recruitment. To clarify participant expectations and increase adherence to study procedures. |
Added Information from the instructions, Att 12 B Food Record Instructions |
This will assist the clinic manager and improve the flow of the initial clinic visit – rather than having to switch between forms, the food record collection instructions are also now included on this form. All applicable instructions are consolidated on one form. The clinic manager will then give the Food Record Instructions and Form to the participant to take home. |
Deleted Scheduling Information |
Scheduling for the 24-hour dietary recall is moved to a separate form for ease in EMAILing - See Att_8a Dietary Recall Scheduling Form. The clinic manager will provide the participant with a calendar with the agreed upon dates for the 24-hour dietary recall interviews and the duplicate salt collection dates. |
Att 9 Study Orientation for Sub Study Participants – modification of text
Rationale: On Att 8 and Att 9, the text orienting participants to the study components has been modified so that all of the study components are described on these forms and reviewed by the study manager. The participants are then provided written copies of the corresponding information collection forms and instructions for review at home. In addition, the scheduling for the dietary recall which was a part of this form will now be collected on a separate form (Att 8a) to be sent to the University of Minnesota Nutrition Coordination Center.
Modification (in red as applicable) |
Rationale |
The following sentence “One of these days must be a weekend day; the other three will be weekdays” will be added. |
See Att_4A: Screening and Recruitment. To clarify participant expectations and increase adherence to study procedures. |
Added Information from the instructions for the Att 12 B Food Record Instructions |
This will assist the clinic manager and improve the flow of the initial clinic visit – rather than having to switch between forms, the food record collection instructions are also now included on this form. All applicable instructions are consolidated on one form. The clinic manager will then give the Food Record Instructions and Form to the participant to take home. |
Deleted Scheduling Information |
Moved to a separate form for ease in EMAILing - See Att_8a Dietary Recall Scheduling Form. The salt collection date will be written on each packet given to the participant. The clinic manager will provide the participant with a calendar with the agreed upon dates. |
Att 12A_Food Record Form
Modification (in red) |
Rationale |
Deleted ID field.
|
Participant ID is not necessary. Form is used by the participant to aid in recall and is NOT collected by study staff. |
Total Amount Prepared (ONLY
|
Clarify instructions for participants. |
Att 15A_24-Hour Urine Collection Form
Modification (in red) |
Rationale |
Return the urine specimen bottle(s) and this sheet to the clinic the day after collection |
Per protocol, participants will be scheduled to come to the clinic the day after their 24 h urine collection is scheduled. |
Store your urine container in a cool place such as a basement, a cooler with ice, or the refrigerator. |
Provide examples of appropriate storage places to clarify instructions. |
Questions? Contact the clinic manager at XXX-XXX-XXXX |
Provide phone number for questions. |
Att 17A_Study Salt Questionnaire
Modification (in red) |
Rationale |
Deleted “ |
To be consistent with language used in explaining the study. |
C. Supporting documents: Modifications or clarifications to instructions.
Att 4B_ Cover letter – Those who cannot be reached by phone
Modification (in red) |
Rationale |
The following sentence “Three of these days must be weekdays and one must be a weekend day” will be added. |
Added to supporting cover letter to correspond with Att_4A: Screening and Recruitment. To clarify participant expectations and increase adherence to study procedures.
|
Deleted the phrase: “home water supply”
|
Added to Cover Letter to correspond with Att_4A: Screening and Recruitment. The home tap water questionnaire will be asked at the end of telephone recruitment after the person schedules a clinic visit rather than at the initial visit to save costs related to mailing water specimens: The amount of water required for analysis is about 1/2 cup (~120 ml) which is much greater than previously expected (10 ml). |
Att 4C Cover letter for phone recruits
Modification (in red) |
Rationale |
Deleted the phrase “and a copy of the Consent Form (blue), which provides additional information about the study.” |
Added to Cover Letter to correspond with Att_4A: Screening and Recruitment. The participants receive the study description and consent form at the initial visit. The consent form will be read to the participant at the initial visit and any questions answered. |
Deleted the phrase: “source of home tap water”
|
Deleted from Cover Letter to correspond with Att_4A: Screening and Recruitment . The home tap water questionnaire will be asked at the end of telephone recruitment after the person schedules a clinic visit rather than at the initial visit to save costs related to mailing water specimens: The amount of water required for analysis is about 1/2 cup (~120 ml) which is much greater than previously expected (10 ml). |
Att 4D Study Fact Sheet
Modification (in red) |
Rationale |
Deleted the phrase: “your home water supply”
|
Deleted from Study Fact Sheet to correspond with Att_4A: Screening and Recruitment. The home tap water questionnaire will be asked at the end of telephone recruitment after the person schedules a clinic visit rather than at the initial visit to save costs related to mailing water specimens: The amount of water required for analysis is about 1/2 cup (~120 ml) which is much greater than previously expected (10 ml). |
Deleted “20” |
The ICR for 0920-0982 specified that burden was 30 minutes. |
The following sentence “One of these days must be a weekend day; the other three will be weekdays” will be added. |
Added to Fact Sheet to correspond with Att_4A: Screening and Recruitment. To clarify participant expectations and increase adherence to study procedures. |
Att 12B_Food Record Form Instruction Sheet
Modification (in red) |
Rationale |
“Make sure you have the completed record, the Food Amounts Booklet, your duplicate salt samples, and any dietary supplements or non-prescription antacids you may have taken the day before the call with you for your scheduled telephone recall.
|
To improve recall of salt added at the table and during home cooking and supplements consumed. |
If you ate a food that was prepared at home with salt added in preparation, write in a description of the total amount of food prepared. ..Describe the total amount made in whatever makes sense for the food (“made 3 cups” of salsa, etc.) |
Clarify instructions for participants with specific examples. |
Att 13B_Duplicate Salt Sample Collection Instructions (Non Sub Study Participants)
Modification (in red) |
Rationale |
“Collection kits and
instructions will be provided
|
Minor modification to clarify instructions. |
At the baseline clinic visit the clinic manager |
Clarify instructions for participants. Eliminate irrelevant instruction. |
• Large, clear Ziplock bag labeled with
clinic manager contact information • ‘Duplicate
Salt Sample Collection Instructions for Participants’
• ‘Food Record Instructions’, ‘Food Record Form’, and ‘Food Amounts Booklet’ • 4 • 12 • Preaddressed postage p |
Minor edits to align instructions with study procedures.
Participant provided with written instructions, Att 13C_Duplicate Salt Sample Collection Instructions for Participants (Non Sub Study). |
This information includes the date and type of salt used.
|
Clarify instructions. The labels are the same for Sub Study and Non-Sub Study participants. |
Att 13C_Duplicate Salt Sample Collection Instructions for Participants (Non Sub Study)
Rationale: The above form (attached) is a set of written instructions which will be provided to participants to accompany the bag labels.
Att 14B_Duplicate Salt Sample Collection Instructions (Sub Study Participants)
Modification (in red) |
Rationale |
“Collection kits and
instructions will be provided
|
Minor modification to improve instructions. |
At the baseline clinic visit the clinic
manager |
Clarify instructions for participants. Eliminate irrelevant instruction. |
• Large, clear Ziplock bag labeled with
clinic manager contact information • ‘Study
Salt Instructions for Participants’ • ‘Food Record Instructions’, ‘Food Record Form’, and ‘Food Amounts Booklet’ • 4 • 12 • Preaddressed postage p |
Minor edits to align instructions with study procedures. |
This information includes the date and type of salt used.
|
Clarify instructions. The labels are the same for Sub Study and Non-Sub Study participants. |
After the sub study participants have received their Study Salt (when they have returned their first 24-hour urine collection) they will be asked to collect duplicate samples of the Study Salt in the same manner. |
Clarify instructions |
Duplicate salt samples received will be
logged at each study site |
Clarify instructions |
Att 15B_How to collect the urine (24-Hour Urine Collection Instructions)
Modification (in red) |
Rationale |
|
Participants will be provided a calendar with their days of urine collection (see Att 9) |
When you wake up, urinate (pee) in the
toilet as usual. DO NOT collect this urine, but BE SURE TO write
down the date and time of this first urine of the day on the first
label on the storage container and
the ‘24-Hour Urine Collection Form’, on
This is the last urine you will collect. Write down the date and time of this last urine on the label on the storage container and the 24-Hour Urine Collection Form. |
Clarify instructions. |
Att 17B_Study Salt Instructions for Participants
Modification (in red) |
Rationale |
Deleted “Supplement” from the phrase “Study Salt
|
To be consistent with language used in explaining the study. |
Salt added to food at the table
For your first collection day you will use your own salt. After you receive the Study Salt, (when you drop off your first urine collection) please use it whenever you wish to add salt to your food at the table. This includes salt added to food at home and away from home. Remember to take the salt shaker with you wherever you go so that you’re able to use it if you eat at work, restaurants, and other places away from home, |
Additional instructions provided to be consistent with recording information about salt use on the baggie labels for duplicate salt collection. |
Salt added in preparing food at
home
Please also provide duplicate samples of all salt added to your food in home cooking. Any salt added to food prepared outside your home does not need to be collected. Put the same amount of salt added to the dish in a bag with a white label immediately after adding salt to the dish. Record the date, name of the dish prepared and type of salt used (regular salt including sea salt, iodized salt, non-iodized salt, and kosher salt; or another type such as lite salt or salt substitute for your first collection; “Study Salt” for the three subsequent collections) on the bag label. Record the total amount of the dish you prepared on the ‘Food Record Form’. Each dish you add salt to in your home cooking will have a separate bag of duplicate salt so you may use multiple white-labeled bags for one collection day.
For your first collection day you will use your own salt. After you receive the Study Salt, (when you drop off your first urine collection) please use it whenever you add salt to food in home cooking. If someone else in your home is preparing a food that includes salt, make sure they use the salt provided by the study. |
Additional instructions provided to be consistent with recording information about salt use on the baggie labels for duplicate salt collection. |
When to start using the Study Salt
Start using the Study Salt as soon as it is given to you by clinic staff at your first 24-hour urine collection drop-off.
When to stop using the Study Salt
Use the Study Salt up until the time you return the salt shaker and salt container to the clinic with your final 24 hour urine sample. Please return your duplicate salt samples to the clinic at this time as well. Ensure that all the bags are tightly sealed and each label has been filled out completely. If you did not add salt at the table or use salt in home cooking, please return the empty bags to the coordinating center (the neon labeled bags should have the box checked noting that you did not add salt at the table on that day). |
Additional Instructions provided to be consistent with study procedures. |
|
The questionnaire will be administered at the follow-up visit as stated in the protocol and supporting statement. |
Att 17C_Study Salt Record (to be completed by study staff)
Modification (in red) |
Rationale |
Deleted “Supplement” from the phrase “Study Salt Supplement” |
To be consistent with language used in explaining the study and the title of the document. |
Deleted “Participant Name” |
Not needed |
Table Salt |
Help with clarity |
Att 17D_Study Salt Procedures for Study Staff
Modification (in red) |
Rationale |
Deleted “Supplement” from the phrase “Study Salt Supplement” |
To be consistent with language used in explaining the study and the title of the document. |
Study Salt Sets Each set will include the following: • • Glass • Glass
|
The deleted phrases are duplicated in the instructions for the Duplicate Salt Collection. Use of common measures will help the staff. |
File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
Author | CDC User |
File Modified | 0000-00-00 |
File Created | 2021-01-28 |