Att 14B_Dup Salt Sample Collection Instr (Sub Study)_01082014

Form Approved

OMB No. 0920-0982

Expiration date: 09/30/2015

Duplicate Salt Sample Collection Instructions (Sub Study Participants)

Public reporting burden of this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to  CDC/ATSDR Reports Clearance Officer, 1600 Clifton Road, NE, M/S D74, Atlanta, GA 30333, ATTN: PRA 0920-0982.

Overview

Participants will be asked to collect the study duplicate samples of the salt they add to food in home cooking and salt added to food at the table both in and outside the home. The samples will be collected on four days over an 11 day period, with their collection synchronized with the telephone 24-hour dietary recalls to be collected from participants (samples will be collected the day prior to each telephone recall). Collection kits and instructions will be provided to participants during the baseline clinic visit.

Distribution of Collection Kits

At the baseline clinic visit the clinic manager will schedule the dates duplicate salt samples are to be collected using the ‘Study Orientation for Sub Study Participants’. Verbal instructions will be provided following the script on the forms. Written instructions will be included in each salt collection kit.

Salt Collection Kits

Each salt collection kit will include the following:

• Large, clear Ziplock bag labeled with clinic manager contact information

• ‘Study Salt Instructions for Participants’ printed on colored paper

• ‘Food Record Instructions’, ‘Food Record Form’, and ‘Food Amounts Booklet’

• 4 sandwich bags with zip seal and neon label affixed to each for recording sample information (for collection of duplicate table salt samples)

• 12 sandwich bags with zip seal and white label affixed to each for recording sample information (for collection of duplicate samples of salt used in home cooking)

• Pen

Collection

Salt added to food at the table

Participants will be asked to provide duplicate samples of all salt added to their food at the table throughout the day. This includes salt added to food at home and away from home. A sandwich size zip bag will be provided for this task. The participant will be asked to shake the same amount of salt shaken onto their food into the bag immediately following adding salt to their food at the table. If they forget to do this during the meal, they should do it as soon as possible afterward. During the collection day there is some information the participant needs to record on the label affixed to the bag. This information includes the type of salt used. 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. You (the clinic manager) should record the date of table salt collection on each bag to correspond with the calendar provided to the participant.

Salt added to food in home cooking

Participants will be asked to provide duplicate samples of all salt added to their food during home food preparation. Any salt added to food prepared outside the home does not need to be collected. Sandwich size zip bags will be provided for collecting separate duplicate samples for each dish/food prepared at home with salt added. The participant will be instructed to put the same amount of salt added to the dish in a plastic bag immediately after adding salt to the dish. The participant will be asked to record certain information about the sample on a label adhered to each bag. Information to be recorded will include the date, a description of the dish/food salt was added to in preparation, and an indication of the type of salt used. 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.

Receipt and Follow-Up

Duplicate salt samples received will be logged at each study site. Participants will be asked to return all duplicate samples when they drop off their final 24-hour urine collection. If the duplicate salt samples have not been received within one week of the scheduled collection date the participant will be sent a reminder telephone call and an email or poster card (depending on participant’s communication preference).