Physical Activity and Dietary Behaviors of Adults 18 to 80 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Comparison of the level of compliance and retention between the two groups.
研究概览
简要总结
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.
详细描述
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emails will also state that those subjects not completing their "follow-up" visit within the visit window will be withdrawn from the study.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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Individuals who do not have access to the Internet
结局指标
主要结局
Comparison of the level of compliance and retention between the two groups.
时间窗: Six months
次要结局
- Mean physical activity levels of trial completers relative to their mean baseline PA levels.(Six months)
- Mean body mass index (BM) of trial completers relative to their mean baseline BMI.(Six Months)
- Changes in PA levels, fat intake scores and BMI over time for subjects in each treatment arm.(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).(Six months)
- Mean fat intake score of trial completers relative to their mean baseline fat intake.(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.(Six months)
- Subject reported satisfaction with participation in an on-line study(Six months)