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emails will also state that those subjects not completing their "follow-up" visit within the visit window will be withdrawn from the study.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