C.4.12 Exemplar IRB Protocol LOI2-QUEX-14

ATTACHMENT C.4.12 Protocol Summary OMB#: 0925-0593

Excerpted from Exemplar Local IRB Protocol) EXPIRATION DATE: 07/31/2013

LOI2-QUEX-14

Methods

We are proposing use of existing data within the Vanguard Centers (VCs) and outside (UC Denver), as well as the collection of new data to achieve our overall goals. Specifically we propose the following activities:

1. Use the NCS screener information from the VCs to determine proportion of participants that have internet access.

2. Use the NCS aging report to determine if the timing of recruitment of pregnant women into the NCS allows for the completion of 2-3 ASA24 recalls prior to delivery.

Study activities in Hawaii NCS diet ancillary study:

• Collect three 24-hour recalls using ASA24 and three days of food records in pregnant women at a frequency of one per month over a three-month time period and at the end, administer the NCS-DHQ.

• Collect three 24-hour recalls using ASA24 and three days of food records in infants at 11-12 months of age and children 2-5 years of age in a one month time period and at the end administer the NCS-infant feeding practices questionnaire for infants and the child Food Frequency Questionnaire for preschoolers.

• Collect basic sociodemographic information including acculturation data on all subjects as well as quantitatively investigate how respondents of various socio-cultural backgrounds respond to the two proposed dietary assessment tools. This information will be collected through a questionnaire after the completion of the NCS FFQ or infant feeding practices questionnaire. In particular, we will solicit information on subjects’ perceptions and experience in their attempt to complete the NCS questionnaires and respond to the Web-based 24-hour recalls (ASA), and difficulties encountered in completing the two proposed dietary assessments. In the process, we will also determine subjects’ understanding of the questions and seek subjects’ opinions of the appropriateness of the dietary assessment tools.

• Copies of the Hawaii food record data will be sent to Cancer Research Center of Hawaii (CRCH) and, after analysis, the data will be sent to North Carolina. A second set of food record copies from Hawaii will be sent to Baylor (handling pregnant women), Miami (handling children 2-5 years of age), and Minnesota (handling infants 11-12 months of age) for data entry. The NCS-DHQ will be sent to North Carolina.

• Collected food records from Hawaii preschooler participants will also be used to evaluate a dietary index (DASH Index for children), which assesses the quality of eating patterns based on average intakes of important food groups.

Participants: Women of diverse ethnicities (Hispanic, African-American, Chinese, Filipino, South East Indian, and Native Hawaiian or Pacific Islander, and Caucasian) will be recruited from six locations—California, Hawaii, Maryland, Colorado, Minnesota, Texas, and Miami—for the purpose of completing dietary questionnaires for themselves or their infant or preschool-age children.

Inclusion/exclusion criteria:

• Pregnant women: age 18-49, non-institutionalized, <28 weeks gestation, English speaking and of the ethnicity identified for each center;

• Infants: age 11-13 months, living with mother, of mother’s ethnicity identified for each center, free of birth defects, any major chronic health conditions that would interfere with feeding (i.e. inborn errors of metabolism, tube feeding, and cystic fibrosis), and mother is English speaking;

• Children: age 24 months to 4.9 years of age, living with mother, of mother’s ethnicity identified for each center, free of birth defects and any major chronic health conditions that would interfere with feeding (i.e. inborn errors of metabolism, tube feeding, and cystic fibrosis), and mother is English speaking;

• Computer: Availability of computer and internet access

Duration: For pregnant women the diet information will be collected over a period of 3 months and for infants (11-13 months) and children (24 months to 4.9 yrs) the diet information will be collected over a period of 1 month

Recruitment: Participants who are Non-eligible to the main NCS study will be referred to the NCS diet study. If additional participants are needed, they will be recruited from various sites such as Universities, preschools, daycares, Craig’s list, paper advertisements.