Physical Activity and Dietary Behaviors of Adults 18 to 80 Years of Age (Compliance)
2016년 10월 3일 업데이트: 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.
연구 개요
상세 설명
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emails will also state that those subjects not completing their "follow-up" visit within the visit window will be withdrawn from the study.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.
연구 유형
중재적
등록 (실제)
54
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Arizona
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Flagstaff, Arizona, 미국, 86011-5066
- Northern Arizona University
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Missouri
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Columbia, Missouri, 미국, 65212
- University of Missouri
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Group A
Minimum Intervention Group A will fill out data forms at zero (0), two (2), four (4), and six (6) months.
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Minimum Intervention Group A will fill out data forms at zero (0), two (2), four (4), and six (6) months.
다른 이름들:
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활성 비교기: 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.
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Comparison of the level of compliance and retention between the two groups.
기간: Six months
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Six months
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2차 결과 측정
결과 측정 |
기간 |
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Mean physical activity levels of trial completers relative to their mean baseline PA levels.
기간: Six months
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Six months
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Mean fat intake score of trial completers relative to their mean baseline fat intake.
기간: Six months
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Six months
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Mean body mass index (BM) of trial completers relative to their mean baseline BMI.
기간: Six Months
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Six Months
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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).
기간: Six months
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Six months
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Changes in PA levels, fat intake scores and BMI over time for subjects in each treatment arm.
기간: Six months
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Six months
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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.
기간: Six months
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Six months
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Subject reported satisfaction with participation in an on-line study
기간: Six months
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Six months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Pamela S Cooper, PhD, University of Missouri-Columbia
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 7월 1일
기본 완료 (실제)
2010년 4월 1일
연구 완료 (실제)
2010년 4월 1일
연구 등록 날짜
최초 제출
2008년 3월 18일
QC 기준을 충족하는 최초 제출
2008년 3월 18일
처음 게시됨 (추정)
2008년 3월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 10월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 10월 3일
마지막으로 확인됨
2016년 10월 1일
추가 정보
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