Justification for Change

National Birth Defects Prevention Study

OMB 0920-0010

Non-Substantive Change

Project Officer:

Jennita Reefhuis, PhD

Epidemiologist

Centers for Disease Control and Prevention

Phone: (404) 498-3917

Fax: (404) 498-3040

Email: [email protected]

April 6, 2010

The National Birth Defects Prevention Study, (OMB 0920-0010)

Non-substantive Change Request

GENERAL OVERVIEW

The Centers for Birth Defects Research and Prevention (CBDRP) is a collaborative effort between the CDC’s National Center on Birth Defects and Developmental Disabilities (the CDC’s Metropolitan Atlanta Congenital Defects Program) and nine birth defects surveillance registries across the United States. This project specifically: 1) bolsters ongoing surveillance activities (including the integration of prenatal diagnoses into surveillance registries); 2) develops, implements, and evaluates local studies (including research, special services, and program evaluation); and 3) contributes 400 interviews per year (300 case interviews and 100 control interviews) to the National Birth Defects Prevention Study (NBDPS). The NBDPS is a case-control study of birth defects risk factors and is based on the birth defects surveillance registries in the nine CBDRP. To date, NBDPS interviews have been conducted with 35,644 women, including 25,957 mothers of infants with birth defects and 9,687 mothers of infants without birth defects.

Non-Substantive Change Request: Description

We propose the addition of seven (7) questions to the National Birth Defects Prevention Study (NBDPS) Interview in order to provide information about the prevalence of periconceptional physical activity and association of physical activity and major birth defects. These seven questions are taken from the International Physical Activity Questionnaire (IPAQ). The full IPAQ assesses all domains of physical activity.  It has been validated against accelerometers in US non-pregnant adults (correlations 0.12-0.86).²³ In a recent study that used this questionnaire modified to assess physical activity before pregnancy, the adjusted odds ratio for gestational diabetes among women who were inactive vs. "minimally" active was 5.4 (2.6-11.4).²⁴  We have slightly modified the seven IPAQ questions which focus on usual physical activities to assess the timeframe “during the 3 months before you became pregnant” because our objective is to measure periconceptional activity and we assume that physical activity changes little over the three months before pregnancy through the end of the first trimester. This version of the IPAQ was pilot tested among three CDC volunteer staff members who were between 6 and 24 months postpartum. The volunteers were asked about the clarity, comfort, wording and overall assessment. Average administration time was four minutes. Therefore, the seven physical activity questions proposed will add four additional minutes to the current interview which is estimated to take one hour. The placement of these questions will be in SECTION P: Physical Activity (pages 79-81), between SECTION I: Father’s Occupation and SECTION J: Family’s Demographic of the questionnaire. The placement location was determined to ensure the additional questions do not affect the responses to other questions. This new section will not be in alphabetical order and was purposely arranged this way to avoid relabeling the current questions.

Non-Substantive Change Request: Justification

About one-third of US women of childbearing age are obese and about 2.9% have diabetes.^1,2 The prevalence of diabetes is increasing.³ Both obesity and diabetes are risk factors for birth defects.^4,5 Physical activity is one measure recommended for the prevention and treatment of obesity and diabetes.⁶ Given that only 26% of US non-pregnant and 16% of pregnant women in the year 2000 met recommendations for physical activity,^6,7 promotion of physical activity may represent an important strategy to prevent birth defects. Knowledge about the association between physical activity and birth defects is limited to eight studies: six of these studies assessed occupational or work activity (e.g., standing, heavy lifting),^8-13 one assessed well-conditioned athletes vs. less active women,¹⁴ and one assessed leisure time physical activity.¹⁵ None examined all domains of physical activity including work, housework, transportation (e.g., walking to work), and leisure time.

Change in Annualized Burden Hours

Adding additional questions will increase the interview length from one hour to 64 minutes. Thirty-six hundred interviews are conducted annually (2,700 cases and 900 controls) resulting in a burden of 3,840 hours; the previous interview burden was 3,600 hours. The burden hours of the collection of cheek cells by the mother, father, and infant will not change. The total annual burden is increased by 240 hours, from 5,400 to 5,640 hours.

Table A. Estimates of Annualized Burden Hours

Respondents	Number of Respondents	Number of responses per respondent	Avg. burden per response ( minutes)	Total Burden Hours
NBDPS case/control interview	3,600	1	64/60	3,840
Biologic Specimen Collection	10,800	1	10/60	1,800
Total				5,640

Change in Annualized Burden Hours

The interview time has increased from 60 minutes to 64 minutes for 3,600 interviewees, resulting in an increase in burden cost from $54,000 to $56,400 annually. The cheek cell collection burden costs are unchanged.

Table B. Estimated Annualized Burden Costs

Type of Respondents	No. of Respondents	No. Reponses per Respondent	Avg. Burden per Resp (in min)	Total Burden Hours	*Hourly Wage Rate	Total Respondent Costs
Mother/Infants	7,200	1	10/60	1,200	$10.00	$ 12,000
Fathers	3,600	1	10/60	600	$10.00	$ 6,000
Interviewees	3,600	1	64/60	3,840	$10.00	$ 38,400
Total						$ 56,400

*Approximately 75% of women of child-bearing age do participate in the U.S. workforce (see http://www.bls.gov/opub/ted/2000/feb/wk3/art03.htm). A subset of these child-bearing women are part-time and not full-time workers. We have used the National Compensation Survey to aid in our calculation of the hourly wage rate for our table entitled "Estimated Annualized Burden Costs" (please see the U.S. Department of Labor publication entitled: "National Compensation Survey: Occupational Wages in the United States, June 2006" located at http://www.bls.gov/ncs/ocs/sp/ncbl0910.pdf). We have thus calculated an hourly wage rate of $10.00 for the respondents for this ICR.

Modified International Physical Activity Questionnaire (IPAQ)

SECTION P: PHYSICAL ACTIVITY

I am going to ask you about the time you spent being physically active in the three months before you became pregnant. Please answer each question even if you do not consider yourself to be an active person. Think about the activities you do at work, as part of your house and yard work, to get from place to place, and in your spare time for recreation, exercise or sport.
Now, think about all the vigorous activities which take hard physical effort that you did in the three months before you became pregnant. Vigorous activities make you breathe much harder than normal and may include heavy lifting, digging, aerobics, running, or fast bicycling. Think only about those physical activities that you did for at least 10 minutes at a time.
P1.	During the three months before you became pregnant, in a typical week on how many days did you do vigorous physical activities? PROBE: Think only about those physical activities that you do for at least 10 minutes at a time.		DAYS PER WEEK RANGE: 0-7 DON’T KNOW/NOT SURE -1 REFUSED -2 IF 0, DK, OR RF, SKIP TO P3.
P2.	How much time did you usually spend doing vigorous physical activities on one of those days? PROBE: Think only about those physical activities that you do for at least 10 minutes at a time.		HOURS PER DAY RANGE: 0-16 MINUTES PER DAY RANGE: 0-960 OR In the three months before you became pregnant, how much time in total would you spend in a typical week doing vigorous physical activities? HOURS PER WEEK RANGE: 0-112 MINUTES PER WEEK RANGE: 0-6720 DON’T KNOW/NOT SURE -1 REFUSED -2
Now think about activities which take moderate physical effort that you did in the three months before you became pregnant. Moderate physical activities make you breathe somewhat harder than normal and may include child care while standing, carrying light loads at home or work, scrubbing or mopping floors, or bicycling at a regular pace. Do not include walking. Again, think about only those physical activities that you did for at least 10 minutes at a time.
P3.	During the three months before you became pregnant, in a typical week on how many days did you do moderate physical activities? PROBE: Think only about those physical activities that you do for at least 10 minutes at a time. PROBE: Child care includes dressing, bathing, grooming, feeding, or occasional lifting.		DAYS PER WEEK RANGE: 0-7 DON’T KNOW/NOT SURE -1 REFUSED -2 IF 0, DK, OR RF, SKIP TO P5
P4.	How much time did you usually spend doing moderate physical activities on one of those days? PROBE: Think only about those physical activities that you do for at least 10 minutes at a time.		HOURS PER DAY RANGE: 0-16 MINUTES PER DAY RANGE: 0-960 OR In the three months before you became pregnant, what is the total amount of time you spent in a typical week doing moderate physical activities? HOURS PER WEEK RANGE: 0-112 MINUTES PER WEEK RANGE: 0-6720 DON’T KNOW/NOT SURE -1 REFUSED -2
Now think about the time you spent walking in the three months before you became pregnant. This includes at work and at home, walking to travel from place to place, and any other walking that you might do solely for recreation, sport, exercise, or leisure.
P5.	During the three months before you became pregnant, in a typical week on how many days did you walk for at least 10 minutes at a time? PROBE: Think only about the walking that you do for at least 10 minutes at a time.		DAYS PER WEEK RANGE: 0-7 DON’T KNOW/NOT SURE -1 REFUSED -2 IF 0, DK, OR RF, SKIP TO P7
P6.	How much time did you usually spend walking on one of those days?		HOURS PER DAY RANGE: 0-16 MINUTES PER DAY RANGE: 0-960 OR In the three months before you became pregnant, what is the total amount of time you spent walking in a typical week? HOURS PER WEEK RANGE: 0-112 MINUTES PER WEEK RANGE: 0-6720 DON’T KNOW/NOT SURE -1 REFUSED -2

Now think about the time you spent sitting on week days in the three months before you became pregnant. Include time spent at work, at home, while doing course work, and during leisure time. This may include time spent sitting at a desk, visiting friends, reading or sitting or lying down to watch television.
P7.	In the three months before you became pregnant, in a typical week, how much time did you usually spend sitting on a week day? PROBE: Include time spent lying down (awake) as well as sitting.		HOURS PER DAY RANGE: 0-16 MINUTES PER DAY RANGE: 0-960 OR What is the total amount of time you spent sitting on a typical Wednesday? HOURS ON WEDNESDAY RANGE: 0-16 MINUTES ON WEDNESDAY RANGE: 0-960 DON’T KNOW/NOT SURE -1 REFUSED -2

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