Effectiveness of an Eight Week Online Mediterranean Based Diet
Effectiveness of an Eight Week Online Mediterranean Based Diet in an Overweight or Obese Outpatient Primary Care Population
調査の概要
状態
条件
詳細な説明
Eligible participants will be identified by primary care providers or their staff at clinical outpatient site(s). Study is 3-arm randomized control trial where participants will be randomized to 1) Control group (CTL)-will not receive access to online program nor intervention for first 12 weeks; 2) GFFY-1-will receive access to online program without MA intervention 3) GFFY-2-will receive access to online program and MA intervention with weekly phone call. The core of the intervention is an 8-week Mediterranean diet and behavioral online program called "Go! Foods for You (GFFY)" which is offered on the Cleveland Clinic's 360.5.com website. The research will last for 24 weeks. Questionnaire data and biometric measurements will be collected at pre and post intervention (0-8 weeks) and at followup (12 and 24 weeks). Regardless of randomization, participants will be asked to provide their weight every week and an activity log at the end of each week of the program. A urine sample to measure F2-isoprostane will be collected at week 0 and 12 for GFFY-2 and CTL groups.
A preparatory phase requiring the involvement of MAs to provide weekly support to participants is necessary to test process and communication with MAs. Enrollment of 10-20 volunteers for the preparatory phase is desired. Data collected during this phase will not be part of study analysis. To test data collection process, we may ask a few participants to complete baseline questionnaire only.
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ohio
-
Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Foundation
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Body Mass Index (BMI) of 25 or greater.
- Age 18 to 70 years old.
- Patient of a participating Internal Medicine or Family Medicine primary care provider at a Cleveland Clinic Family Health Center.
- Registered on the Cleveland Clinic's electric medical records, My Chart.
Exclusion Criteria:
- Women who are pregnant or planning to be pregnant in the next 6 months.
- No easy internet and email access at place of residence.
- No access to a scale at place of residence for weekly weight measurement.
- Sudden unintentional weight loss or weight gain in the past 3 months due to medical illness
- Currently involved in a weight loss program
- unwilling to be in the wait-list control group where participant will not have access to the program for 3 months
- unwilling to log onto the internet on a regular basis for the duration of the study (3-4 months)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：Control Group
No intervention provided.
These participants will receive access to the Go! Foods for You program after the research trial has been completed (12 weeks after registration).
|
|
|
アクティブコンパレータ：GFFY-1 without weekly MA support
Utilization of the 8-week online nutrition program Go! Foods for You without weekly contact from staff at the medical provider's office.
|
|
|
アクティブコンパレータ：GFFY-2 with weekly MA support
Utilization of the 8-week online nutrition program combined with weekly contact from the staff at the medical provider's office.
|
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Weight Loss
時間枠：12 weeks
|
To see if the 8-week Mediterranean diet online program (GFFY) can lead to weight loss at 12 week.
|
12 weeks
|
|
Effect of Weekly Communications on Adherence and Program Efficacy
時間枠：12 weeks
|
To see if extension of the patient/medical provider relationship through weekly emails by a medical assistant who addresses the program behavioral goals set by the patient leads to greater weight loss.
|
12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Effect on Oxidative Stress
時間枠：12 weeks
|
To see if the program reduces bio markers of oxidative stress (F2 isoprostanes) for participants in the GFFY-2 compared to the CTL group.
|
12 weeks
|
|
Correlation between MA Support and Program Utilization
時間枠：12 weeks
|
To see if participation in GFFY with MA support can improve program participation as measured by 8-week program completion rate and average weekly activities completed during the 8-week program.
|
12 weeks
|
|
Effect on Physical and Mental Health
時間枠：12 weeks
|
To see if an 8-week Mediterranean diet online program help improve overall physical and mental health as measured by the RAND Corporation Health Survey tool (SF36Rand).
|
12 weeks
|
|
Sustainability of Weight Loss
時間枠：24 weeks
|
To see if weight loss from participation in the GFFY programs is sustained at 24 weeks (6 months) follow-up.
|
24 weeks
|
|
Dietary Improvements
時間枠：12 weeks
|
To see if participation in GFFY increases fiber intake, percentage fat and fruit and vegetable consumption as measured by a brief online food screening questionnaire
|
12 weeks
|
|
Increase in Intake of a Mediterranean-based Diet
時間枠：12 weeks
|
To see if participation in GFFY increases intake of a Mediterranean based diet as measured by a short Mediterranean diet questionnaires.
|
12 weeks
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB# 11-475
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。