Clinical trial NCT00641849: Physical Activity and Dietary Behaviors of Adults 18 to 80 Years of Age
Official title: Physical Activity and Dietary Behaviors of Adults 18 to 80 Years of Age
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Physical Activity
Keywords: BMI
Physical Activity
Food
Nutrition
Dietary behaviors
Diet
Adult
Adults
Fat
Fats
Self monitoring
Automated feedback
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Northern Arizona University
First posted: 2008-03-24
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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emails will also state that those subjects not completing their "follow-up" visit within the visit window will be withdrawn from the study.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 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

Primary outcomes:
measure: Comparison of the level of compliance and retention between the two groups.
timeFrame: Six months
Secondary outcomes:
measure: Mean physical activity levels of trial completers relative to their mean baseline PA levels.
timeFrame: Six months
measure: Mean fat intake score of trial completers relative to their mean baseline fat intake.
timeFrame: Six months
measure: Mean body mass index (BM) of trial completers relative to their mean baseline BMI.
timeFrame: Six Months
measure: 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).
timeFrame: Six months
measure: Changes in PA levels, fat intake scores and BMI over time for subjects in each treatment arm.
timeFrame: Six months
measure: 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.
timeFrame: Six months
measure: Subject reported satisfaction with participation in an on-line study
timeFrame: Six months
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: Northern Arizona University
state: Arizona
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Pamela S Cooper, PhD
role: PRINCIPAL_INVESTIGATOR
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