Physical Activity and Dietary Behaviors of Adults 18 to 80 Years of Age (Compliance)

This study has been terminated.
(Terminated by PI r/t lack of funding and retirement of study personel.)
Sponsor:
Collaborator:
Northern Arizona University
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00641849
First received: March 18, 2008
Last updated: June 21, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Physical Activity
Behavioral: Email reminders

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Physical Activity and Dietary Behaviors of Adults 18 to 80 Years of Age

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Comparison of the level of compliance and retention between the two groups. [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean physical activity levels of trial completers relative to their mean baseline PA levels. [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Mean fat intake score of trial completers relative to their mean baseline fat intake. [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Mean body mass index (BM) of trial completers relative to their mean baseline BMI. [ Time Frame: Six Months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Changes in PA levels, fat intake scores and BMI over time for subjects in each treatment arm. [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Subject reported satisfaction with participation in an on-line study [ Time Frame: Six months ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: July 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
Minimum Intervention Group A will fill out data forms at zero (0), two (2), four (4), and six (6) months.
Behavioral: Email reminders
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.
Active Comparator: 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.
Behavioral: Email reminders
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641849

Locations
United States, Arizona
Northern Arizona University
Flagstaff, Arizona, United States, 86011-5066
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Northern Arizona University
Investigators
Principal Investigator: Pamela S Cooper, PhD University of Missouri-Columbia
  More Information

Additional Information:
Publications:
Pfohl M, Schatz H. Strategies for the prevention of type 2 diabetes. Exp Clin Endocrinol Diabetes 2001;109(suppl 2):S240-S249.
Institutes of Medicine. Dietary reference intakes: Energy, carbohydrates, fiber, fat, fatty acides, cholesterol, protein and amino acids. National Academy Press, 2002.
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.

Responsible Party: René Blagg, RN, University of Missouri
ClinicalTrials.gov Identifier: NCT00641849     History of Changes
Other Study ID Numbers: 1103057
Study First Received: March 18, 2008
Last Updated: June 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
BMI
Physical Activity
Food
Nutrition
Dietary behaviors
Diet
Adult
Adults
Fat
Fats
Self monitoring
Automated feedback

ClinicalTrials.gov processed this record on October 29, 2014