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

October 3, 2016 updated by: 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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emails will also state that those subjects not completing their "follow-up" visit within the visit window will be withdrawn from the study.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

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Flagstaff, Arizona, United States, 86011-5066
        • Northern Arizona University
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: Group A
Minimum Intervention Group A will fill out data forms at zero (0), two (2), four (4), and six (6) months.
Other Names:
  • Minimal intervention
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: 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.
Other Names:
  • Maximum intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of the level of compliance and retention between the two groups.
Time Frame: Six months
Six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean physical activity levels of trial completers relative to their mean baseline PA levels.
Time Frame: Six months
Six months
Mean fat intake score of trial completers relative to their mean baseline fat intake.
Time Frame: Six months
Six months
Mean body mass index (BM) of trial completers relative to their mean baseline BMI.
Time Frame: Six Months
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
Six months
Changes in PA levels, fat intake scores and BMI over time for subjects in each treatment arm.
Time Frame: Six months
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
Six months
Subject reported satisfaction with participation in an on-line study
Time Frame: Six months
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Collaborators

Northern Arizona University

Investigators

  • Principal Investigator: Pamela S Cooper, PhD, University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

March 18, 2008

First Submitted That Met QC Criteria

March 18, 2008

First Posted (Estimate)

March 24, 2008

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

October 3, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1103057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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