Physical Activity and Dietary Behaviors of Adults 18 to 80 Years of Age (Compliance)
3 ottobre 2016 aggiornato da: 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.
Panoramica dello studio
Stato
Terminato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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emails will also state that those subjects not completing their "follow-up" visit within the visit window will be withdrawn from the study.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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
54
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Arizona
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Flagstaff, Arizona, Stati Uniti, 86011-5066
- Northern Arizona University
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Missouri
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Columbia, Missouri, Stati Uniti, 65212
- University of Missouri
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 80 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 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.
Altri nomi:
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Comparatore attivo: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Comparison of the level of compliance and retention between the two groups.
Lasso di tempo: Six months
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Six months
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Mean physical activity levels of trial completers relative to their mean baseline PA levels.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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).
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: Six months
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Six months
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Subject reported satisfaction with participation in an on-line study
Lasso di tempo: Six months
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Six months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Pamela S Cooper, PhD, University of Missouri-Columbia
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 luglio 2008
Completamento primario (Effettivo)
1 aprile 2010
Completamento dello studio (Effettivo)
1 aprile 2010
Date di iscrizione allo studio
Primo inviato
18 marzo 2008
Primo inviato che soddisfa i criteri di controllo qualità
18 marzo 2008
Primo Inserito (Stima)
24 marzo 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
4 ottobre 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 ottobre 2016
Ultimo verificato
1 ottobre 2016
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 1103057
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .