SupportingStatement_BodyWorksToolkit

Supporting Statement for

BodyWorks Data Collection

Supporting Statement for Paperwork Reduction Act Submission

July 6, 2006

Prepared for

Jonelle C. Rowe M.D.
Senior Advisor on Adolescent Health
Office on Women's Health
200 Independence Ave. SW
Room 728E
Washington, DC 20201

Prepared by

Health Systems Research, Inc.

Supporting Statement for

BodyWorks Data Collection

1. JUSTIFICATION

1. The purpose of this collection is to evaluate information on the effectiveness of both the BodyWorks toolkit and its train-the-trainer model.

The ultimate goal of the BodyWorks program is to generate behavior changes among caregivers and young girls by creating awareness around making better food choices and increasing physical activity. The program is designed to integrate a variety of audiences into its successful dissemination and delivery. The primary audience for the toolkit is the parents and caregivers of 11-to 13-year-old girls; however the BodyWorks program also includes components for first-tier trainers, those that will train the trainers; second-tier trainers, those that will train the parent/caregiver; and naturally, the adolescent girls themselves.

The BodyWorks evaluation will explore the effectiveness of the program by assessing outcomes such as healthy behavior changes among participating adults and their daughters; attitudinal changes, such as parents beliefs that they have an active role to play in their child’s healthy development; and changes in the levels of parent or caregiver self-efficacy in supporting healthy eating and physical activity.

An initial 10,000 BodyWorks packets will be distributed in 2006. An evaluation is critical to determine how the target audiences use BodyWorks and to assess the impact of the BodyWorks program within families. The evaluation will help to determine the effectiveness of the initiative and guide future distribution and implementation guidance as well as programs relevant to overweight and obesity prevention. To achieve this objective the U.S. Department of Health and Human Services’ Office on Women’s Health (OWH) has contracted with a firm with significant expertise in developing and implementing carefully tailored evaluation designs for major health behavior change initiatives.

2. This information will be used by the OWH to evaluate effectiveness of the BodyWorks program and make recommendations on how its distribution and use could be changed or improved while the program is still active. Also, it will furnish important outcome data to show the program’s impact on the primary audience for the toolkit, the parents/caregivers of 11- to 13-year-old girls, and to a lesser extent, the girls themselves. There has been no previous collection of this information and there is no current collection.

3. The questionnaire does not involve the use of automated, electronic, mechanical, or other technological collection techniques or forms of information technology. Instead a paper questionnaire will be distributed to the caregivers at the beginning and end of their BodyWorks training. A small subset of adolescent girls will be surveyed using a paper questionnaire at the end of the training during a joint caregiver/adolescent activity. By linking questionnaire administration to the BodyWorks training it is anticipated that the burden on participants will be reduced because they will not have to come in at a later time, but rather complete it as part of a class session.

4. This evaluation will be the first evaluation of the completed BodyWorks toolkit and the training associated with its use. A rigorous evaluation will provide rich data and information that can be used to improve the BodyWorks program during its life and not just retrospectively.

5. No small businesses and very few other small entities will be impacted by this information collection. The scope of the data collection itself is very limited and will not impose an undue burden on even the smallest organization.

6. The viability and utility of the BodyWorks program may be adversely affected because there is currently a lack of data to measure changes in impacts on outcomes, knowledge, intentions, and behaviors over time and across different implementation sites.

7. Parents/Caregivers will be asked to complete the pre-test questionnaire at the beginning of their BodyWorks training, and the post-test questionnaire during the last training session ten weeks later. The pre-post design is very important to measuring the impacts of the program, and doing so at the last class will most likely enhance the ability to capture responses from the greatest number of respondents. It will also decrease the burden on respondents, since they will not have to respond once the training is complete.

8. In accordance with the Paperwork Reduction Act of 1995, an announcement of the U.S. Department of Health and Human Services’ Office on Women’s Health’s intent to seek OMB approval to collect information for the evaluation provided an opportunity for public comment. This announcement was published in the Federal Register, Wednesday, May 3, 2006, Volume 71, Number 85, pp. 26093, and specified a 60-day period for comment ending July 1, 2006. A copy of the Federal Register Notice is provided in Appendix A.

The Federal Register announcement generated one comment.

Until the usda and fda gives the american public safe food to eat that has no drugs and chemicals in it, the american public has no chance to avoid either obesity
or unhealthy bodies. This survey is useless until we start examining closely what these two govt bodies do. They feed us bovine growth hormone which is unmarked
so we cant even tell which milk contains it. They feed animals all of these drugs and chemicals to make them grow quickly and then kill the animals with the drugs
still in their system. They put out drugs without doing the many tests that should be done before they are unleashed on the public and then wait to see who
dies from it. 

This survey is unnecessary since the quality of life that is emanating from other govt depts is
substantially bad. 

I think this is a waste of tax dollars.
B. Sachau
15 elm st
florham park nj 07932

As the comment duly notes, the issues raised are beyond the scope of this evaluation. BodyWorks will also serve to raise awareness of healthy eating and physical fitness.

A notice about the study will be published in the Federal Register when this request for OMB review is submitted, providing another opportunity for public comment.

b. Because of the very minimal nature of the information collection requirements, there was no outside consultation with the industry on these information collection requirements.

9. A small acknowledgement time and trouble in the form of gift certificates will be given to parent/caregiver and adolescent girl participants when submitting the surveys. We have found that creative acknowledgements to either participants helps boost response rates.

10. The assurance of confidentiality will be given to participants on the questionnaires. The assurance is as follows: “Your information will be used solely for the purpose of this study, and it will be combined with that of other participants and reported only as totals, averages, and other statistics. DHHS complies with all applicable laws that protect your privacy.”

11. There are no questions of a sensitive nature included in either data collection instrument.

12. Estimate of the hour burden of the collection of information:

The maximum hour burden to respondents for completing both instruments is estimated to be 574 hours.

Respondent Type	Burden (in hours)	Number of Respondents	Total Burden (in hours)
Trainer	0.75	65	49
Caregiver	0.75	600	450
Adolescent Female	0.75	100	75
	Total	765	574

b. For the trainers, the burden is estimated to be 49 hours. The number of respondents used for this estimate is 65. For the caregivers, the burden is estimated to be 225 hours for the pretest and 225 hours for the posttest. The number of respondents used for this estimate is 300 for each of the two forms. For the adolescent females, the burden is estimated to be 75 hours. The number of respondents used for this estimate is 100.

b. Assuming an average wage rate of $40,000, per annum of the adult individuals completing the questionnaires, the cost associated with these 499 hours would be $10,800.87 ((40,000/1848)*499). There should be no cost burden associated with collecting data from 11 to 13 year olds.

13. There are no capital, start-up, operation, or maintenance costs. The only cost is the respondents’ time.

14. Provide estimates of annual cost to the Federal Government.

Personnel and support staff costs include costs for a program director and manager. Supplies include paper, photocopying, and other office related materials. Overhead is a fee charged by Health Systems Research, Inc. for administering the contract.

Description	Amount
Personnel and support staff	$107,375.28
Supplies and all other expenses (HSR overhead)	$ 12,246.64
Total cost	$119,621.92

15. Since this is a new data collection, all hours will be considered a program increase.

16. The results of this data collection will be tabulated and summarized in a final report that will be submitted to OWH. The technical report will be an internal document and not intended for publication in academic literature or on the Internet. The evaluation results will also be developed as a journal article for submission to peer-reviewed journals. The article will discuss the findings related to the impacts of the BodyWorks toolkit, the use of a train-the-trainer model for dissemination, and the differences in implementation by type of implementing organization. Repeated measures analysis adjusted for the cluster effects of group administration will be the primary analysis used for caregiver data. Descriptive analyses will be conducted for trainer and adolescent data. The project was initiated on September 24, 2005; data collection is schedule to begin August 2006 and will end in October 2007. The analysis, reports and manuscript will be completed in March 2008. The report and draft of the article for publication will be completed by controlling for of satisfaction and effectiveness in modifying eating and physical activity behaviors among caregivers of adolescent girls and their families.

17. We do not seek approval to eliminate the expiration date from the form.

18. There are no exceptions.

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