Physical ActivityComplianceNCT00641849
Physical Activity and Dietary Behaviors of Adults 18 to 80 Years of Age
A study testing Group A and Group B in people with Physical Activity, run by University of Missouri-Columbia at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Group A and Group B
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2008to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -Individuals who do not have access to the Internet
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Missouri
Columbia, Missouri, 65212
Northern Arizona University
Flagstaff, Arizona, 86011-5066
About this study
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.
Read the detailed description
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.
- Conditions
- Physical Activity
- Being tested
- Group A, Group B
- Keywords
- BMI, Physical Activity, Food, Nutrition, Dietary behaviors, Diet, Adult, Adults, Fat, Fats, Self monitoring, Automated feedback
- Medical subject headings
- Motor Activity, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ABehavioural
Also called Minimal intervention
Minimum Intervention Group A will fill out data forms at zero (0), two (2), four (4), and six (6) months.
Group BBehavioural
Also called Maximum intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Minimum Intervention Group A will fill out data forms at zero (0), two (2), four (4), and six (6) months. Receives: 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. Receives: Behavioral: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the level of compliance and retention between the two groups.
Measured: Six months
Secondary outcomes (7)
Mean physical activity levels of trial completers relative to their mean baseline PA levels.
Measured: Six months
Mean fat intake score of trial completers relative to their mean baseline fat intake.
Measured: Six months
Mean body mass index (BM) of trial completers relative to their mean baseline BMI.
Measured: 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).
Measured: Six months
Changes in PA levels, fat intake scores and BMI over time for subjects in each treatment arm.
Measured: Six months
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.
Measured: Six months
Subject reported satisfaction with participation in an on-line study
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Terminated by PI r/t lack of funding and retirement of study personel.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Arizona University
- Responsible party
- Sponsor
- Investigators
- Pamela S Cooper, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641849
- Sponsor's protocol ID
- 1103057
- Acronym
- Compliance
- Status last verified
- Oct 2016
- First submitted
- 18 Mar 2008
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 15214597Pfohl 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.
PubMed 11460574Wannamethee 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.
PubMed 11227978Gorelick 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.
PubMed 10188663Kuller 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.
PubMed 9216562U.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.
PubMed 9160011Pate 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.
PubMed 7823386McGuire 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.
PubMed 22332062Krauss 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.
PubMed 11056107Trumbo 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.
PubMed 12449285National 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.
PubMed 12079438Kahn 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.
PubMed 11985936
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Dietary Behaviors of Adults 18 to 80 Years of Age
- ClinicalTrials.gov ID
- NCT00641849
- Acronym / sponsor ID
- Compliance / 1103057
- Conditions
- Physical Activity
- Keywords
- BMI, Physical Activity, Food, Nutrition, Dietary behaviors, Diet, Adult, Adults
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated by PI r/t lack of funding and retirement of study personel.
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Northern Arizona University
- Study start
- Jul 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Behavioral: Group AMinimum Intervention Group A will fill out data forms at zero (0), two (2), four (4), and six (6) months. |
| Group B | Active comparator | Behavioral: Group BMaximum 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- -Individuals who do not have access to the Internet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group AAlso: Minimal interventionMinimum Intervention Group A will fill out data forms at zero (0), two (2), four (4), and six (6) months. | Behavioural | Group A |
| Group BAlso: Maximum interventionMaximum 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. | Behavioural | Group B |
Primary outcome
Comparison of the level of compliance and retention between the two groups.
Time frame: Six months
7 secondary outcomes
Mean physical activity levels of trial completers relative to their mean baseline PA levels.
Time frame: Six months
Mean fat intake score of trial completers relative to their mean baseline fat intake.
Time frame: Six months
Mean body mass index (BM) of trial completers relative to their mean baseline BMI.
Time frame: 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).
Time frame: Six months
Changes in PA levels, fat intake scores and BMI over time for subjects in each treatment arm.
Time frame: Six months
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.
Time frame: Six months
Subject reported satisfaction with participation in an on-line study
Time frame: Six months
Results and safety
The study was stopped early (reason given: Terminated by PI r/t lack of funding and retirement of study personel.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Background: PubMed 15214597Bauman 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.
- Background: PubMed 11460574Pfohl 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.
- Background: PubMed 11227978Wannamethee 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.
- Background: PubMed 10188663Gorelick 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.
- Background: PubMed 9216562Kuller 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.
- BackgroundU.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.
- Background: PubMed 9160011Physical activity and cardiovascular health. NIH Consens Statement. 1995 Dec 18-20;13(3):1-33.
- Background: PubMed 7823386Pate 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.
- Background: PubMed 22332062McGuire 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.
- Background: PubMed 11056107Krauss 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.
- Background: PubMed 12449285Trumbo 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.
- BackgroundNational Center for Health Statistics. National Health Interview Survey, 2005: Hyattsville MD: National Center for Health Statistics, 2007.
- 7.2.4.3 Sample Size Required." Engineering Statistics Handbook, National Institute of Standards and Technology. 28 February 2008Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela S Cooper, PhD principal investigator
University of Missouri-Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A and Group B in people with Physical Activity, run by University of Missouri-Columbia at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated by PI r/t lack of funding and retirement of study personel.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the level of compliance and retention between the two groups. (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00641849, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.