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National Health and Nutrition Examination Survey 24-hour Urine Collection Feasibility Study, 2013

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ClinicalTrials.gov Identifier: NCT02723682
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : March 30, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

Brief Summary:
A 24-hour urine pilot study was conducted as part of the 2013 NHANES to test the feasibility of implementing a 24-hour urine collection as part of NHANES in 2014.

Condition or disease Intervention/treatment
Hypertension Other: Collect 24-hour urine specimen

Detailed Description:

The 24-hour urine pilot study was conducted March - June 2013 in three NHANES locations. A random half-sample of non-pregnant US adults, aged 20-69 who were examined in the NHANES mobile examination center were selected. Participants received instructions, started and ended the urine collection in a urine study mobile examination center (UMEC), and answered questions about collection. A random half of participants who collected a complete 24-h urine were asked to collect a second 24-h urine. Urinary sodium, potassium, chloride, and creatinine excretion were analyzed.

Participation rates in two other post-examination components, the Physical Activity Monitor and the Dietary Recall, were monitored to determine whether collecting a 24-hour urine had an effect on response rates for the two components.


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Study Type : Observational
Actual Enrollment : 282 participants
Time Perspective: Cross-Sectional
Official Title: National Health and Nutrition Examination Survey 24-Hour Urine Collection Feasibility Study, 2013
Study Start Date : March 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Collect 24-hour urine specimen
    A random half sample of NHANES participants 20-69 examined in the mobile examination center were asked to collect a 24-hour urine specimen.


Primary Outcome Measures :
  1. Study completion rates - initial collection [ Time Frame: 24 hours ]
    Completion rate of initial 24-hour urine collection.

  2. Study completion rate - second collection [ Time Frame: 24 hours ]
    Completion rate of second 24-hour urine collection


Secondary Outcome Measures :
  1. Response rates for the Physical Activity Monitor [ Time Frame: 24-hours ]
    Response rates for the Physical Activity Monitor

  2. Response rates for the Phone Follow-up Dietary Recall [ Time Frame: 24-hours ]
    Response rates for the Phone Follow-up Dietary Recall.

  3. Urine volume for the initial urine collection [ Time Frame: 24 hours ]
    Urine volume adjusted to 24 hours, initial urine collection

  4. Urine volume for the second urine collection [ Time Frame: 24 hours ]
    Urine volume adjusted to 24 hours, second urine collection

  5. Urinary sodium excretion for the initial urine collection [ Time Frame: 24 hours ]
    24-hour urinary sodium excretion, initial urine collection

  6. Urinary sodium excretion for the second urine collection [ Time Frame: 24 hours ]
    24-hour urinary sodium excretion, second urine collection



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
NHANES participants aged 20-69 years who were examined in the mobile examination center.
Criteria

Inclusion Criteria:

  • 20-69 year old adults examined in the NHANES mobile examination center

Exclusion Criteria:

  • pregnant, unable to respond for themselves

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723682


Locations
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United States, Maryland
National Health and Nutrition Examination Survey
Hyattsville, Maryland, United States, 20782
Sponsors and Collaborators
Centers for Disease Control and Prevention
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Study Director: Kathryn Porter, MD, MS Centers for Disease Control and Prevention, National Center for Health Statistics, Division of Health and Nutrition Examination Surveys

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02723682     History of Changes
Other Study ID Numbers: 2011-17
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The NHANES 24-hour urine pilot study data set can be made available through the National Center for Health Statistics Research Data Center by submitting a research proposal at http://www.cdc.gov/rdc/.