Physical Activity and Dietary Behaviors of Adults 18 to 80 Years of Age (Compliance)
3. Oktober 2016 aktualisiert von: University of Missouri-Columbia
This research will focus on the effect of a 6-month behavioral intervention delivered via the World Wide Web that is aimed at increasing physical activity levels and decreasing dietary fat intake in a general population of adults.
The study will be randomized and blinded.
We are also planning to study subjects' compliance and retention rates when enrolled in a completely on-line study.
Studienübersicht
Status
Beendet
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The research is designed as a prospective multi-site, randomized, blinded trial.
Participants will fill out an initial questionnaire 72 hours (time 0) after completing the inclusion/exclusion questionnaire and consent documents. An email will be sent sixty (60) hours after participants who agreed to the online consent and HIPAA articles. Subjects who have consented to participate in the trial will not be considered as enrolled until after they have completed their time 0 data forms and completed the education module.
The subjects will be randomly assigned to either the minimum or maximum treatment group. Both groups will be sent an email reminder 7 days prior to their "follow-up" date. They will then be sent an email reminder 24 hours prior to their "follow-up" date. Subjects will receive an email reminder every 48 hours until 336 hours (14 days) post visit date. Reminder emails will also state that those subjects not completing their "follow-up" visit within the visit window will be withdrawn from the study. Subjects will be not be blinded as to how frequently they will be required to make "follow-up" visits to the site.
Group A: Minimum Intervention Group A will fill out data forms at zero (0), two (2), four (4), and six (6) months.
Group B: Maximum Intervention Group B will fill out data forms at zero (0), one (1), two (2), three (3), four (4), five (5), and six (6) months.
A short online education module will be given after the initial surveys (time 0) have been completed by the study subject. They will receive their initial "feedback" letter after completing the education module. It will also tell them the date of their "follow-up" visit, and that they will be periodically prompted to return to the site and complete a questionnaire.
Both groups will receive a "feedback" letter upon completion of each online "follow-up" visit. This letter will give them "feedback" based off of how they answered their data forms. All "feedback" given will be based off of established recommended physical activity and the USDA food pyramid guidelines. The BMI will be calculated; BMI = weight (kg)/height2 (m2).
Subjects in both groups who have not completed their "follow-up" visits after 336 hours (14 days) post visit date will be sent an email notifying them that they have been dropped from the study.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
54
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Arizona
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Flagstaff, Arizona, Vereinigte Staaten, 86011-5066
- Northern Arizona University
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Missouri
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Columbia, Missouri, Vereinigte Staaten, 65212
- University of Missouri
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Adults 18 years to 80 years
- Participants must be willing to complete initial questionnaire 72 hours after completing inclusion criteria screening and review of informed consent
- Participants must be willing to review educational module
- Participants must be willing to fill out seven (7) questionnaires per protocol.
Exclusion Criteria:
-Individuals who do not have access to the Internet
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: Group A
Minimum Intervention Group A will fill out data forms at zero (0), two (2), four (4), and six (6) months.
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Minimum Intervention Group A will fill out data forms at zero (0), two (2), four (4), and six (6) months.
Andere Namen:
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Aktiver Komparator: Group B
Maximum Intervention Group B will fill out data forms at zero (0), one (1), two (2), three (3), four (4), five (5), and six (6) months.
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Maximum Intervention Group B will fill out data forms at zero (0), one (1), two (2), three (3), four (4), five (5), and six (6) months.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Comparison of the level of compliance and retention between the two groups.
Zeitfenster: Six months
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Six months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Mean physical activity levels of trial completers relative to their mean baseline PA levels.
Zeitfenster: Six months
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Six months
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Mean fat intake score of trial completers relative to their mean baseline fat intake.
Zeitfenster: Six months
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Six months
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Mean body mass index (BM) of trial completers relative to their mean baseline BMI.
Zeitfenster: Six Months
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Six Months
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Comparison of mean physical activity level, fat intake scores, and BMI of trial completers in each treatment arm at 6 months (outcome means adjusted for baseline values).
Zeitfenster: Six months
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Six months
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Changes in PA levels, fat intake scores and BMI over time for subjects in each treatment arm.
Zeitfenster: Six months
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Six months
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Intent-to treat analysis will be conducted at outcome for physical activity, fat intake scores and BMI by carrying the last entered values forward to represent the values at outcome. Intent to treat analysis may be precluded by a high dropout rate.
Zeitfenster: Six months
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Six months
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Subject reported satisfaction with participation in an on-line study
Zeitfenster: Six months
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Six months
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Pamela S Cooper, PhD, University of Missouri-Columbia
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Krauss RM, Eckel RH, Howard B, Appel LJ, Daniels SR, Deckelbaum RJ, Erdman JW Jr, Kris-Etherton P, Goldberg IJ, Kotchen TA, Lichtenstein AH, Mitch WE, Mullis R, Robinson K, Wylie-Rosett J, St Jeor S, Suttie J, Tribble DL, Bazzarre TL. AHA Dietary Guidelines: revision 2000: A statement for healthcare professionals from the Nutrition Committee of the American Heart Association. Circulation. 2000 Oct 31;102(18):2284-99. doi: 10.1161/01.cir.102.18.2284. No abstract available.
- Trumbo P, Schlicker S, Yates AA, Poos M; Food and Nutrition Board of the Institute of Medicine, The National Academies. Dietary reference intakes for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein and amino acids. J Am Diet Assoc. 2002 Nov;102(11):1621-30. doi: 10.1016/s0002-8223(02)90346-9. No abstract available. Erratum In: J Am Diet Assoc. 2003 May;103(5):563.
- McGuire S. U.S. Department of Agriculture and U.S. Department of Health and Human Services, Dietary Guidelines for Americans, 2010. 7th Edition, Washington, DC: U.S. Government Printing Office, January 2011. Adv Nutr. 2011 May;2(3):293-4. doi: 10.3945/an.111.000430. Epub 2011 Apr 30. No abstract available.
- Tate DF, Jackvony EH, Wing RR. A randomized trial comparing human e-mail counseling, computer-automated tailored counseling, and no counseling in an Internet weight loss program. Arch Intern Med. 2006 Aug 14-28;166(15):1620-5. doi: 10.1001/archinte.166.15.1620.
- Harvey-Berino J, Pintauro S, Buzzell P, DiGiulio M, Casey Gold B, Moldovan C, Ramirez E. Does using the Internet facilitate the maintenance of weight loss? Int J Obes Relat Metab Disord. 2002 Sep;26(9):1254-60. doi: 10.1038/sj.ijo.0802051.
- Bauman AE. Updating the evidence that physical activity is good for health: an epidemiological review 2000-2003. J Sci Med Sport. 2004 Apr;7(1 Suppl):6-19. doi: 10.1016/s1440-2440(04)80273-1.
- Pfohl M, Schatz H. Strategies for the prevention of type 2 diabetes. Exp Clin Endocrinol Diabetes. 2001;109 Suppl 2:S240-9. doi: 10.1055/s-2001-18585.
- Wannamethee SG, Shaper AG. Physical activity in the prevention of cardiovascular disease: an epidemiological perspective. Sports Med. 2001 Feb;31(2):101-14. doi: 10.2165/00007256-200131020-00003.
- Gorelick PB, Sacco RL, Smith DB, Alberts M, Mustone-Alexander L, Rader D, Ross JL, Raps E, Ozer MN, Brass LM, Malone ME, Goldberg S, Booss J, Hanley DF, Toole JF, Greengold NL, Rhew DC. Prevention of a first stroke: a review of guidelines and a multidisciplinary consensus statement from the National Stroke Association. JAMA. 1999 Mar 24-31;281(12):1112-20. doi: 10.1001/jama.281.12.1112.
- Kuller LH. Dietary fat and chronic diseases: epidemiologic overview. J Am Diet Assoc. 1997 Jul;97(7 Suppl):S9-15. doi: 10.1016/s0002-8223(97)00724-4.
- U.S. Dept of Health and Human Services: Physical Actvity and Health: A report of the Sugeon General. Atlanta GA: Centers for Disease Control and Prevention, National Center for Chronic Deases Prevention and Health Promotion 1996.
- Physical activity and cardiovascular health. NIH Consens Statement. 1995 Dec 18-20;13(3):1-33.
- Pate RR, Pratt M, Blair SN, Haskell WL, Macera CA, Bouchard C, Buchner D, Ettinger W, Heath GW, King AC, et al. Physical activity and public health. A recommendation from the Centers for Disease Control and Prevention and the American College of Sports Medicine. JAMA. 1995 Feb 1;273(5):402-7. doi: 10.1001/jama.273.5.402.
- National Center for Health Statistics. National Health Interview Survey, 2005: Hyattsville MD: National Center for Health Statistics, 2007.
- U.S. Department of Health and Human Services. Healthy People 2010: National health promotion and disease prevention objectives. Washington DC: U.S Department of Health and Human Services 2000.
- Ammerman AS, Lindquist CH, Lohr KN, Hersey J. The efficacy of behavioral interventions to modify dietary fat and fruit and vegetable intake: a review of the evidence. Prev Med. 2002 Jul;35(1):25-41. doi: 10.1006/pmed.2002.1028.
- Kahn EB, Ramsey LT, Brownson RC, Heath GW, Howze EH, Powell KE, Stone EJ, Rajab MW, Corso P. The effectiveness of interventions to increase physical activity. A systematic review. Am J Prev Med. 2002 May;22(4 Suppl):73-107. doi: 10.1016/s0749-3797(02)00434-8.
- Sherwood NE, Jeffery RW. The behavioral determinants of exercise: implications for physical activity interventions. Annu Rev Nutr. 2000;20:21-44. doi: 10.1146/annurev.nutr.20.1.21.
- Gillman MW, Pinto BM, Tennstedt S, Glanz K, Marcus B, Friedman RH. Relationships of physical activity with dietary behaviors among adults. Prev Med. 2001 Mar;32(3):295-301. doi: 10.1006/pmed.2000.0812.
- Eaton CB, McPhillips JB, Gans KM, Garber CE, Assaf AR, Lasater TM, Carleton RA. Cross-sectional relationship between diet and physical activity in two southeastern New England communities. Am J Prev Med. 1995 Jul-Aug;11(4):238-44.
- AbuSabha R, Achterberg C. Review of self-efficacy and locus of control for nutrition- and health-related behavior. J Am Diet Assoc. 1997 Oct;97(10):1122-32. doi: 10.1016/S0002-8223(97)00273-3.
- Marcus BH, Lewis BA, Williams DM, Dunsiger S, Jakicic JM, Whiteley JA, Albrecht AE, Napolitano MA, Bock BC, Tate DF, Sciamanna CN, Parisi AF. A comparison of Internet and print-based physical activity interventions. Arch Intern Med. 2007 May 14;167(9):944-9. doi: 10.1001/archinte.167.9.944.
- Armitage CJ, Conner M. Efficacy of a minimal intervention to reduce fat intake. Soc Sci Med. 2001 May;52(10):1517-24. doi: 10.1016/s0277-9536(00)00265-3.
- Marcus BH, Bock BC, Pinto BM, Forsyth LH, Roberts MB, Traficante RM. Efficacy of an individualized, motivationally-tailored physical activity intervention. Ann Behav Med. 1998 Summer;20(3):174-80. doi: 10.1007/BF02884958.
- Marcus BH, Emmons KM, Simkin-Silverman LR, Linnan LA, Taylor ER, Bock BC, Roberts MB, Rossi JS, Abrams DB. Evaluation of motivationally tailored vs. standard self-help physical activity interventions at the workplace. Am J Health Promot. 1998 Mar-Apr;12(4):246-53. doi: 10.4278/0890-1171-12.4.246.
- Brug J, Steenhuis I, van Assema P, de Vries H. The impact of a computer-tailored nutrition intervention. Prev Med. 1996 May-Jun;25(3):236-42. doi: 10.1006/pmed.1996.0052.
- Cook RF, Billings DW, Hersch RK, Back AS, Hendrickson A. A field test of a web-based workplace health promotion program to improve dietary practices, reduce stress, and increase physical activity: randomized controlled trial. J Med Internet Res. 2007 Jun 19;9(2):e17. doi: 10.2196/jmir.9.2.e17.
- McKay HG, King D, Eakin EG, Seeley JR, Glasgow RE. The diabetes network internet-based physical activity intervention: a randomized pilot study. Diabetes Care. 2001 Aug;24(8):1328-34. doi: 10.2337/diacare.24.8.1328.
- Marcus BH, Nigg CR, Riebe D, Forsyth LH. Interactive communication strategies: implications for population-based physical-activity promotion. Am J Prev Med. 2000 Aug;19(2):121-6. doi: 10.1016/s0749-3797(00)00186-0.
- Kroeze W, Werkman A, Brug J. A systematic review of randomized trials on the effectiveness of computer-tailored education on physical activity and dietary behaviors. Ann Behav Med. 2006 Jun;31(3):205-23. doi: 10.1207/s15324796abm3103_2.
- Spittaels H, De Bourdeaudhuij I, Vandelanotte C. Evaluation of a website-delivered computer-tailored intervention for increasing physical activity in the general population. Prev Med. 2007 Mar;44(3):209-17. doi: 10.1016/j.ypmed.2006.11.010. Epub 2007 Jan 2.
- Appendix B22. Dietary Quality: The Food Habits Questionnaire. In: St. Jeor ST, ed. Obesity Assessment: Tools, Methods, Interpretations. New York: Chapman & Hall, 1997, 806-812.
- Silverstein LJ, Scott BJ, Zahrt H. Dietary Quality: The Food Habits Questionnaire. In: St. Jeor ST, ed. Obesity Assessment: Tools, Methods, Interpretations. New York: Chapman & Hall; 1997: 281-291.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Juli 2008
Primärer Abschluss (Tatsächlich)
1. April 2010
Studienabschluss (Tatsächlich)
1. April 2010
Studienanmeldedaten
Zuerst eingereicht
18. März 2008
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
18. März 2008
Zuerst gepostet (Schätzen)
24. März 2008
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
4. Oktober 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
3. Oktober 2016
Zuletzt verifiziert
1. Oktober 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 1103057
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Nein
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