NCT04321057

Brief Summary

Height and weight are important informations in clinical life. Medication is dosed by them and weight, especially overweight, is a risk factor for cardiovascular diseases. Mostly you have to rely on the self-reported informations, because there is plenty of work and little time to weigh and measure every patient. But can the investigators really trust this informations? Former studies have shown, that most of self-reported heights and weights differ from the measured ones. This fact might lead to a wrong dosage of medicine or underestimated risk factors. So the Cardial-MASS-Study tries to detect influencing factors on the reliability of self-reported informations especially among patients, treated at the cardiological department at Saarland University.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
731

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

3.3 years

First QC Date

March 20, 2020

Last Update Submit

March 24, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Self-reported weight

    Patient´s self-reported weight and the measured weight will be compared.

    baseline

  • Self-reported height

    Patient´s self-reported height and the measured height will be compared.

    baseline

Study Arms (6)

Group questionnaire

Patient's height and weight are asked by questionnaire in this group. It includes patients at the cardiological department of Saarland University.

Group male doctor

Patient's height and weight are asked by a male doctor in this group. It includes patients at the cardiological department of Saarland University.

Group female doctor

Patient's height and weight are asked by a female doctor in this group. It includes patients at the cardiological department of Saarland University.

Group male nurse

Patient's height and weight are asked by a male nurse in this group. It includes patients at the cardiological department of Saarland University.

Group female nurse

Patient's height and weight are asked by a female nurse in this group. It includes patients at the cardiological department of Saarland University.

Group family doctor

Patient's height and weight are asked by questionnaire in this group. This is the control group,including patients at a family doctor.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients at Innere Medizin III, who participate voluntarily and who suffer at least from one cardiovascular disease

You may qualify if:

  • Patients at Innere Medizin III (Cardiology), Universitätsklinikum des Saarlandes (UKS)
  • cardiovascular disease (Coronar-Vessel-Disease, Arrhythmia, Heart-attack, Hypertonus, stable heart failure)
  • Patients at a family doctor

You may not qualify if:

  • younger than 18 years
  • Dementia
  • cardial decompensation
  • severe anemia (Hemoglobin\<9 mg/dl)
  • cardial shock
  • acute kidney failure
  • factors, that prevent patients from answering the questionnaire
  • factors, that prevent patients from being measured and weighted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Internal Medicine, Cardioloy, Angioloy, and Internal Intensive Care Medicine, Saarland University Hospital

Homburg, Saarland, 66421, Germany

Location

Related Publications (23)

  • Palta M, Prineas RJ, Berman R, Hannan P. Comparison of self-reported and measured height and weight. Am J Epidemiol. 1982 Feb;115(2):223-30. doi: 10.1093/oxfordjournals.aje.a113294.

    PMID: 7058781BACKGROUND
  • Stewart AL. The reliability and validity of self-reported weight and height. J Chronic Dis. 1982;35(4):295-309. doi: 10.1016/0021-9681(82)90085-6. No abstract available.

    PMID: 7061685BACKGROUND
  • Millar WJ. Distribution of body weight and height: comparison of estimates based on self-reported and observed measures. J Epidemiol Community Health. 1986 Dec;40(4):319-23. doi: 10.1136/jech.40.4.319.

    PMID: 3655624BACKGROUND
  • Stewart AW, Jackson RT, Ford MA, Beaglehole R. Underestimation of relative weight by use of self-reported height and weight. Am J Epidemiol. 1987 Jan;125(1):122-6. doi: 10.1093/oxfordjournals.aje.a114494.

    PMID: 3788941BACKGROUND
  • Rowland ML. Self-reported weight and height. Am J Clin Nutr. 1990 Dec;52(6):1125-33. doi: 10.1093/ajcn/52.6.1125.

    PMID: 2239790BACKGROUND
  • Bowlin SJ, Morrill BD, Nafziger AN, Jenkins PL, Lewis C, Pearson TA. Validity of cardiovascular disease risk factors assessed by telephone survey: the Behavioral Risk Factor Survey. J Clin Epidemiol. 1993 Jun;46(6):561-71. doi: 10.1016/0895-4356(93)90129-o.

    PMID: 8501483BACKGROUND
  • Ziebland S, Thorogood M, Fuller A, Muir J. Desire for the body normal: body image and discrepancies between self reported and measured height and weight in a British population. J Epidemiol Community Health. 1996 Feb;50(1):105-6. doi: 10.1136/jech.50.1.105. No abstract available.

    PMID: 8762365BACKGROUND
  • Bostrom G, Diderichsen F. Socioeconomic differentials in misclassification of height, weight and body mass index based on questionnaire data. Int J Epidemiol. 1997 Aug;26(4):860-6. doi: 10.1093/ije/26.4.860.

    PMID: 9279620BACKGROUND
  • Niedhammer I, Bugel I, Bonenfant S, Goldberg M, Leclerc A. Validity of self-reported weight and height in the French GAZEL cohort. Int J Obes Relat Metab Disord. 2000 Sep;24(9):1111-8. doi: 10.1038/sj.ijo.0801375.

    PMID: 11033979BACKGROUND
  • Kuczmarski MF, Kuczmarski RJ, Najjar M. Effects of age on validity of self-reported height, weight, and body mass index: findings from the Third National Health and Nutrition Examination Survey, 1988-1994. J Am Diet Assoc. 2001 Jan;101(1):28-34; quiz 35-6. doi: 10.1016/S0002-8223(01)00008-6.

    PMID: 11209581BACKGROUND
  • Jalkanen L, Tuomilehto J, Tanskanen A, Puska P. Accuracy of self-reported body weight compared to measured body weight. A population survey. Scand J Soc Med. 1987;15(3):191-8. doi: 10.1177/140349488701500311.

    PMID: 3616534BACKGROUND
  • Roberts RJ. Can self-reported data accurately describe the prevalence of overweight? Public Health. 1995 Jul;109(4):275-84. doi: 10.1016/s0033-3506(95)80205-3.

    PMID: 7667492BACKGROUND
  • Jeffery RW. Bias in reported body weight as a function of education, occupation, health and weight concern. Addict Behav. 1996 Mar-Apr;21(2):217-22. doi: 10.1016/0306-4603(95)00050-x.

    PMID: 8730524BACKGROUND
  • Bray GA. Overweight is risking fate. Definition, classification, prevalence, and risks. Ann N Y Acad Sci. 1987;499:14-28. doi: 10.1111/j.1749-6632.1987.tb36194.x.

    PMID: 3300479BACKGROUND
  • Pi-Sunyer FX. Medical hazards of obesity. Ann Intern Med. 1993 Oct 1;119(7 Pt 2):655-60. doi: 10.7326/0003-4819-119-7_part_2-199310011-00006.

    PMID: 8363192BACKGROUND
  • Lavie CJ, Milani RV, Ventura HO. Obesity and cardiovascular disease: risk factor, paradox, and impact of weight loss. J Am Coll Cardiol. 2009 May 26;53(21):1925-32. doi: 10.1016/j.jacc.2008.12.068.

    PMID: 19460605BACKGROUND
  • Kurth T, Gaziano JM, Berger K, Kase CS, Rexrode KM, Cook NR, Buring JE, Manson JE. Body mass index and the risk of stroke in men. Arch Intern Med. 2002 Dec 9-23;162(22):2557-62. doi: 10.1001/archinte.162.22.2557.

    PMID: 12456227BACKGROUND
  • Dorn JM, Schisterman EF, Winkelstein W Jr, Trevisan M. Body mass index and mortality in a general population sample of men and women. The Buffalo Health Study. Am J Epidemiol. 1997 Dec 1;146(11):919-31. doi: 10.1093/oxfordjournals.aje.a009218.

    PMID: 9400333BACKGROUND
  • Bender R, Trautner C, Spraul M, Berger M. Assessment of excess mortality in obesity. Am J Epidemiol. 1998 Jan 1;147(1):42-8. doi: 10.1093/oxfordjournals.aje.a009365.

    PMID: 9440397BACKGROUND
  • Coe TR, Halkes M, Houghton K, Jefferson D. The accuracy of visual estimation of weight and height in pre-operative supine patients. Anaesthesia. 1999 Jun;54(6):582-6. doi: 10.1046/j.1365-2044.1999.00838.x.

    PMID: 10403874BACKGROUND
  • Hendershot KM, Robinson L, Roland J, Vaziri K, Rizzo AG, Fakhry SM. Estimated height, weight, and body mass index: implications for research and patient safety. J Am Coll Surg. 2006 Dec;203(6):887-93. doi: 10.1016/j.jamcollsurg.2006.08.018. Epub 2006 Oct 25.

    PMID: 17116557BACKGROUND
  • Foil MB, Collier MS, MacDonald KG Jr, Pories WJ. Availability and Adequacy of Diagnostic and Therapeutic Equipment for the Morbidly Obese Patient in an Acute Care Setting. Obes Surg. 1993 May;3(2):153-156. doi: 10.1381/096089293765559494.

    PMID: 10757911BACKGROUND
  • Therre M, Kindermann I, Wedegartner SM, Gross S, Schwantke I, Mahfoud F, Bohm M. Determinants of reliability of self-reported height and weight and their impact on medication dosing: a cross-sectional study. BMJ Open. 2025 Apr 15;15(4):e090020. doi: 10.1136/bmjopen-2024-090020.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2020

First Posted

March 25, 2020

Study Start

April 1, 2017

Primary Completion

July 1, 2020

Study Completion

June 1, 2021

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations