NCT00641849

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

2 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

March 18, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

October 4, 2016

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

March 18, 2008

Last Update Submit

October 3, 2016

Conditions

Keywords

BMIPhysical ActivityFoodNutritionDietary behaviorsDietAdultAdultsFatFatsSelf monitoringAutomated feedback

Outcome Measures

Primary Outcomes (1)

  • Comparison of the level of compliance and retention between the two groups.

    Six months

Secondary Outcomes (7)

  • Mean physical activity levels of trial completers relative to their mean baseline PA levels.

    Six months

  • Mean fat intake score of trial completers relative to their mean baseline fat intake.

    Six months

  • Mean body mass index (BM) of trial completers relative to their mean baseline BMI.

    Six Months

  • 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).

    Six months

  • Changes in PA levels, fat intake scores and BMI over time for subjects in each treatment arm.

    Six months

  • +2 more secondary outcomes

Study Arms (2)

Group A

ACTIVE COMPARATOR

Minimum Intervention Group A will fill out data forms at zero (0), two (2), four (4), and six (6) months.

Behavioral: Group A

Group B

ACTIVE COMPARATOR

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.

Behavioral: Group B

Interventions

Group ABEHAVIORAL

Minimum Intervention Group A will fill out data forms at zero (0), two (2), four (4), and six (6) months.

Also known as: Minimal intervention
Group A
Group BBEHAVIORAL

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.

Also known as: Maximum intervention
Group B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18 years to 80 years
  • Participants must be willing to review educational module
  • Participants must be willing to fill out seven (7) questionnaires per protocol.

You may not qualify if:

  • Individuals who do not have access to the Internet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northern Arizona University

Flagstaff, Arizona, 86011-5066, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related Publications (34)

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    BACKGROUND
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    PMID: 9160011BACKGROUND
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    PMID: 22332062BACKGROUND
  • 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.

    PMID: 11056107BACKGROUND
  • 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.

    PMID: 12449285BACKGROUND
  • National Center for Health Statistics. National Health Interview Survey, 2005: Hyattsville MD: National Center for Health Statistics, 2007.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 12079438BACKGROUND
  • 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.

    PMID: 11985936BACKGROUND
  • 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.

    PMID: 10940325BACKGROUND
  • 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.

    PMID: 11277687BACKGROUND
  • 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.

    PMID: 7495600BACKGROUND
  • 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.

    PMID: 9336559BACKGROUND
  • 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.

    PMID: 17502536BACKGROUND
  • 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.

    PMID: 16908795BACKGROUND
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    PMID: 11314848BACKGROUND
  • 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.

    PMID: 9989324BACKGROUND
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    PMID: 10178617BACKGROUND
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    PMID: 8781000BACKGROUND
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    PMID: 17581811BACKGROUND
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    PMID: 11473065BACKGROUND
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    PMID: 10913903BACKGROUND
  • 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.

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  • 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.

    PMID: 17197015BACKGROUND
  • 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.

    PMID: 12187404BACKGROUND
  • 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.

    PMID: 12900694BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Motor ActivityPlatelet Glycoprotein IV Deficiency

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Pamela S Cooper, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2008

First Posted

March 24, 2008

Study Start

July 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

October 4, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations