Interactive Diet and Activity Tracking in AARP (iDATA): Biomarker Based Validation Study (NCI)

Forms and Documents

Document Name	Status
Form 22 Att.34 ACT24 Form	New
Form 21 Att.33 DHQ Form	New
Form 20 Att.32 ASA24 Form	New
Form 19 Att.22 Stanford Physical Activity Screener Form	New
Form 18 Att.21 Sedentary Behavior Questionnaire Form	New
Form 17 Att.20 AARP Physical Activity questions Form	New
Form 16 Att.19 CHAMPS Activities Questionnaire Form	New
Form 15 Att.18 Harvard Lifestyle Questionnaire for iDATA Form	New
Form 14 Att.17 4 Day Food Record iDATA Form and Instruction	New
Form 13 Att.16 7-Day Food Checklist iDATA Form and Instruction	New
Form 12 Att.15 Saliva collection instructions Form and Instruction	New
Form 11 Att.14 24 hr Urine Collection Log Form and Instruction	New
Form 10 Att.13 Anthropometry Form	New
Form 9 Att.12 PA Monitor Log Form and Instruction	New
Form 8 Att.11A and 11B PARQ PARmedX Form	New
Form 7 Att 10 FitnessTest protocol Form	New
Form 6 Att 8 Heart Rate Monitor Log Form and Instruction	New
Form 5 Att 7 RMR Protocol Form and Instruction	New
Form 4 Att 6 DLW Protocol and Form.doc Form	New
Form 3 Att 5 Fasting Blood Protocol and Form Form and Instruction	New
Form 2 Att 3 Clinic Eligibility Screening Interview Form	New
Form 1 Att 1 Pre-Screening Telephone Interview Form	New
SSB iDATA_5-5-2011.docx Supporting Statement B	2011-05-10
Att.29 NCI & Westat IRB Approval.pdf Supplementary Document	2011-05-13
Att.31 Email Invite to New AARP Members.docx Supplementary Document	2011-05-10
Att.30B Invitation letters New AARP Members.docx Supplementary Document	2011-05-10
Att.30A Invitation letters AARP Cohort.docx Supplementary Document	2011-05-10
Att.27 Westat Procedures for Keeping Data Confidential.doc Supplementary Document	2011-05-10
Att.26 Privacy Act Memo.pdf Supplementary Document	2011-05-10
Att.28 Confidentiality Statement.pdf Supplementary Document	2011-05-10
Att.25 External Scientific Consultants.docx Supplementary Document	2011-05-10
Att.24 iDATA Study Advisory Group Members.docx Supplementary Document	2011-05-10
Att.23 PIA.docx Supplementary Document	2011-05-10
Att.9 Informed Consent substudy.doc Supplementary Document	2011-05-10
Att.4B Informed Consent main study-new members.doc Supplementary Document	2011-05-10
Att.4A Informed Consent main study-AARP cohort.doc Supplementary Document	2011-05-10
Att.2 iDATA Study Brochure.docx Supplementary Document	2011-05-10
Cover Memo_iDATA.doc Supplementary Document	2011-05-10
SSA iDATA_5-13-2011.docx Supporting Statement A	2011-05-13

IC Document Collections

IC ID	Document Title	Status
197738	Att.34 ACT24 Form	New
197737	Att.33 DHQ Form	New
197736	Att.32 ASA24 Form	New
197735	Att.22 Stanford Physical Activity Screener Form	New
197734	Att.21 Sedentary Behavior Questionnaire Form	New
197733	Att.20 AARP Physical Activity questions Form	New
197732	Att.19 CHAMPS Activities Questionnaire Form	New
197731	Att.18 Harvard Lifestyle Questionnaire for iDATA Form	New
197730	Att.17 4 Day Food Record iDATA Form and Instruction	New
197729	Att.16 7-Day Food Checklist iDATA Form and Instruction	New
197728	Att.15 Saliva collection instructions Form and Instruction	New
197727	Att.14 24 hr Urine Collection Log Form and Instruction	New
197726	Att.13 Anthropometry Form	New
197725	Att.12 PA Monitor Log Form and Instruction	New
197724	Att.11A and 11B PARQ PARmedX Form	New
197723	Att 10 FitnessTest protocol Form	New
197722	Att 8 Heart Rate Monitor Log Form and Instruction	New
197721	Att 7 RMR Protocol Form and Instruction	New
197720	Att 6 DLW Protocol and Form.doc Form	New
197719	Att 5 Fasting Blood Protocol and Form Form and Instruction	New
197718	Att 3 Clinic Eligibility Screening Interview Form	New
197717	Att 1 Pre-Screening Telephone Interview Form	New

ICR Details

OMB Control No: 0925-0640	ICR Reference No: 201105-0925-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Interactive Diet and Activity Tracking in AARP (iDATA): Biomarker Based Validation Study (NCI)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/25/2011
	Date Received in OIRA: 05/17/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2014	36 Months From Approved
Responses	34,826	0	0
Time Burden (Hours)	15,061	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The measurement error structure of the ASA24 and ACT24 needs to be evaluated. The iDATA Study will compare objectively measured energy expenditure, protein, nutrients, and physical activity with the self-reported intakes of energy, protein, nutrients, and physical activity using the ASA24 and ACT24, as well as conventional self-report instruments for assessing diet and physical activity in a free-living population aged 50 to 74 years and residing in the Pittsburgh, Pennsylvania area. To date there has not been a comparable effort to understand the properties and measurement error structure of self-report physical activity instruments. The burgeoning epidemic of obesity highlights the need to explore this in both aspects of energy balance - dietary intake and energy expenditure through physical activity. Other studies have shown significant disagreement between typical, long-term memory-based self-reported activity and objective wearable motion detection devices. To address this, NCI has developed a new internet-based instrument, ACT24, which measures the participant's past 24-hour activities in order to improve the accuracy of self-reported physical activity. Results from previous studies have indicated that multiple 24-hour dietary recalls over the course of one year provide more accurate information about usual dietary exposure and create less bias in estimated risk compared with the typical Food Frequency Questionnaires (FFQ) that asks participants to remember dietary information over the entire past year. An obstacle to the 24-hour recall method is that it is typically administered by interviewers, and is prohibitively expensive to use in large studies, especially multiple administrations. In response, NCI has developed a self-administered internet-based version, ASA24, which allows multiple recalls to be collected at very limited study expense and relatively low participant burden.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 13647	03/14/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 28052	05/13/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 22

IC Title	Form No.	Form Name
Att.34 ACT24	22	Att.34 ACT24
Att 1 Pre-Screening Telephone Interview	1	Att 1 Pre-Screening Telephone Interview
Att 3 Clinic Eligibility Screening Interview	2	Att 3 Clinic Eligibility Screening Interview
Att 5 Fasting Blood Protocol and Form	3	Att 5 Fasting Blood Protocol and Form
Att 6 DLW Protocol and Form.doc	4	Att 6 DLW Protocol and Form.doc
Att 7 RMR Protocol	5	Att 7 RMR Protocol
Att 8 Heart Rate Monitor Log	6	Att.8 Heart Rate Monitor Log
Att 10 FitnessTest protocol	7	Att 10 FitnessTest protocol
Att.15 Saliva collection instructions	12	Att.15 Saliva collection instructions
Att.16 7-Day Food Checklist iDATA	13	Att.16 7-Day Food Checklist iDATA
Att.19 CHAMPS Activities Questionnaire	16	Att.19 CHAMPS Activities Questionnaire
Att.20 AARP Physical Activity questions	17	Att.20 AARP PA questions
Att.21 Sedentary Behavior Questionnaire	18	Att.21 Sedentary Behavior Questionnaire
Att.17 4 Day Food Record iDATA	14	Att.17 4 Day Food Record iDATA
Att.18 Harvard Lifestyle Questionnaire for iDATA	15	Att.18 Harvard Lifestyle Questionnaire for iDATA
Att.12 PA Monitor Log	9	Att.12 PA Monitor Log
Att.22 Stanford Physical Activity Screener	19	Att.22 Stanford Physical Activity Screener
Att.32 ASA24	20	Att.32 ASA24
Att.11A and 11B PARQ PARmedX	8	Att.11A and 11B PARQ PARmedX
Att.13 Anthropometry	10	Att.13 Anthropometry
Att.14 24 hr Urine Collection Log	11	Att.14 24 hr Urine Collection Log
Att.33 DHQ	21	Att.33 DHQ

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	34,826	0	0	34,826	0	0
Annual Time Burden (Hours)	15,061	0	0	15,061	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection of information.

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Annual Cost to Federal Government: $1,333,333

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 05/17/2011

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