肥満および/または心血管代謝リスクが高い過体重患者の治療に対するテレニュートリションの有効性 (TOOLBAR)
肥満および/または心血管代謝リスクが高い過体重患者の治療に対するテレニュートリション (OBE-COACH) の有効性
The OBE-COACH program is an automated online nutritional coaching service that was evaluated in its first version (MXS-CARE program) in a clinical trial coordinated by our team, in type 2 diabetic patients with abdominal obesity. Results have confirmed the efficiency of the program to improve lifestyle habits, including the 4-month diet, and to reduce weight and HbA1c levels.
Based on our experience and the scientific literature, the investigators assume that adherence to the program may diminish in the long term to the point of calling into question its efficiency. So IRIADE compagny developed an enhanced program called OBE-COACH. The OBE-COACH program has been specifically designed to facilitate long-term user adherence. The OBE-COACH program, integrates a bidirectional interactive link between the patient and an automated support system (IRIADE-MED system) associated with an inexpensive remote human support.
In the TOOLBAR study, the investigators will evaluate the efficiency of the OBE-COACH solution in a population of obese patients or overweight persons with at least one cardiometabolic risk factor.
A group of patients will have access to the OBE-COACH program. It will be compared to a control group which will receive an e-learning program with free access to advice sheets via the web, to a menu generator, videos and a catalog of physical activity, (resources made available by the web site www.mangerbouger.fr (public health France, ministry in charge of health) . Indeed, the investigators judged that the loss of patients during follow-up would be greater if e-learning was not offered in the control group.
調査の概要
状態
条件
詳細な説明
The management of patients in the TOOLBAR study will be in accordance with French recommendations: a patient who is overweight should benefit from a dietary, physical activity, psychological assistance and medical monitoring advices which can be provided by a general practitioner. In the control group, subjects have access to an e-learning program, including free access via the web to a nutritional information portal and to automated tools providing information and advice for adopting a balanced, low-carb diet and to practice physical activity in line with the guidelines of the national health nutrition plan (PNNS). However, this group will not have access to the OBE-COACH program. The usual follow-up with the attending doctor will be continued.
Patients will be assessed at baseline, 6 months and 12 months. In an ancillary study they could be also assessed at 24 months.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Paris、フランス、75013
- Hôpital La Pitié Salpêtrière
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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:
- Men or women 18 to 75 years
- Obesity defined by a body mass index > 30 kg / m2 or a BMI> 25 kg / m2 with the presence of at least one major cardiometabolic risk factors among the followings: dyslipidemia, hypertension, diabetes, prediabetes
- Stable weight in the last six months (weight variation < 4 kg peak-to-peak)
- Access and current use of internet, possession of an email address and a smartphone.
- Understanding and reading French
- Patient not currently following a nutritional monitoring and not having planned to be engaged in a nutritional monitoring during the coming year
Exclusion Criteria:
- Excessive alcohol consumption > 30 g / day -Pregnant or breastfeeding woman
- symptomatic cardiovascular disease : angina, lower extremity arterial occlusive disease, stroke or myocardial infarction dating of less than 6 months.
- Uncontrolled psychiatric illness
- Patients receiving or about to receive during the study period a systemic or local treatment susceptible to interfere with the evaluation of the primary criteria (corticosteroids, antipsychotics, tricyclic antidepressants) except if these treatments have been stable for at least 6 months without a plan to modify the dose during the 12 months of the study
- Adhering to a prescribed diet for weight loss, in the past 3 months
- Person with a severe eating disorder: bulimia, binge eating disorder according to DSM-V criteria - Presence of celiac disease, Crohn's disease or other metabolic disorder or condition affecting nutritional needs such as allergies or food intolerances (except partial lactose intolerance)
- Anticipated difficulties in following the patient
- Lack of social coverage in France
- Lack of written or electronic informed consent
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：支持療法
- 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 |
|---|---|
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実験的：OBE-COACH program
The OBE-COACH experimental group: access to the complete OBE-COACH program |
OBE-COACH works through private exchanges between the user and an automatic generator of recommendations, advice and messages of encouragement. Web focus groups are propoposed by specialist to respond to the questions of the participants and a tele-interview at 6 months with a dietetician to encourage and assist the patient to make the best use of the program. The program is divided into missions to perform. These missions are grouped into 10 families. The completion of each mission and the correct answers to the quiz offer points and bonuses. To promote better adherence to the program, missions are not repetitive. They are proposed to surprise the user and constantly renew his desire to connect to the program and achieve goals. The intensity level of the program is selected by the user at any time. Connected devices provide to patient are auto-tensiometer and balance. These devices will not be connected to the OBE-COACH program. The auto-tensiometer (Tensio-screen, Terraillon) is a connected tensiometer allowing the patient to measure by himself with an armband his systolic and diastolic blood pressure and his heart rate. The balance (Web coach premium, Terraillon) is a connected scale to collect body weight. The Activity Tracer (activi-T band, Terraillon) is a a wristband connected activity tracer worn on the wrist that tracks the patient's physical activity and calculates the number of steps, distance traveled and calories burned. The Activity Tracer will not be connected to the OBE-COACH program. |
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アクティブコンパレータ：e-learning program
The control group: access to an e-learning program with free access via the web to advice sheets, a menu generator and a catalog of physical activity (resources made available by the site www.mangerbouger.fr ; Public Health France, Ministry of Health) and provision of connected devices (auto-tensiometer and balance). |
Connected devices provide to patient are auto-tensiometer and balance. These devices will not be connected to the OBE-COACH program. The auto-tensiometer (Tensio-screen, Terraillon) is a connected tensiometer allowing the patient to measure by himself with an armband his systolic and diastolic blood pressure and his heart rate. The balance (Web coach premium, Terraillon) is a connected scale to collect body weight. The Activity Tracer (activi-T band, Terraillon) is a a wristband connected activity tracer worn on the wrist that tracks the patient's physical activity and calculates the number of steps, distance traveled and calories burned. The Activity Tracer will not be connected to the OBE-COACH program. e-learning program with free access via the web to advice sheets, a menu generator and a catalog of physical activity (resources made available by the site www.mangerbouger.fr ; Public Health France, Ministry of Health) |
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 |
|---|---|---|
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Weight reduction of at least 5% between 0 and 12 months.
時間枠：12 months
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Weight reduction of at least 5% between 0 and 12 months. The weight, in Kg, will be measured in a state of fastness ≥ 8h, in participants wearing light clothing without shoes on the same scales calibrated at inclusion and 12 months of follow-up. |
12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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検証済みの NAQA アンケートで評価した 0 ～ 12 か月間のタンパク質摂取量の変化 (g/日)
時間枠：12ヶ月
|
12ヶ月
|
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検証済みの NAQA アンケートで評価された、g/日での 0 ～ 12 か月のスクロース摂取量の変化
時間枠：12ヶ月
|
12ヶ月
|
|
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検証済みの NAQA アンケートで評価した、g/日で表した 0 ～ 12 か月間の脂質摂取量の変化
時間枠：12ヶ月
|
12ヶ月
|
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検証済みの NAQA アンケートで評価された、0 ～ 12 か月間のカルシウム摂取量の変化 (mg/日)
時間枠：12ヶ月
|
12ヶ月
|
|
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砂糖入り飲料の消費量の 0 ～ 12 か月間のグラス数/日の変化
時間枠：12ヶ月
|
12ヶ月
|
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1日あたりのグラス数でのアルコール飲料消費量の0～12か月間の変化
時間枠：12ヶ月
|
12ヶ月
|
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砂糖入り飲料の消費量の 0 か月から 6 か月間のグラス数/日の変化
時間枠：6ヶ月
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6ヶ月
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アルコール飲料の消費量の 0 ～ 6 か月間の変化 (グラス数/日)
時間枠：6ヶ月
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6ヶ月
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1 日あたりの本数でのタバコ消費の 0 ～ 12 か月間の変化
時間枠：12ヶ月
|
12ヶ月
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1日あたりの本数でのタバコ消費の0～6ヶ月間の変化
時間枠：6ヶ月
|
6ヶ月
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GPAQアンケートで評価されたタスクの代謝当量、METで測定された、身体活動に関するWHOの推奨事項への遵守の0〜12か月間の変化。
時間枠：12ヶ月
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12ヶ月
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GPAQアンケートで評価されたタスクの代謝当量、METで測定された、身体活動に関するWHOの推奨事項への遵守の0〜6か月間の変化。
時間枠：6ヶ月
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6ヶ月
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12 か月時点での OBE-COACH プログラムの順守は、前月の被験者からの週あたりの回答を伴う質問 (IRIADE から送信) の平均割合によって評価されます。
時間枠：12ヶ月
|
12ヶ月
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過去 6 か月間の Web フォーカス グループへの参加数によって評価される、12 か月時点での OBE-COACH プログラムの順守。
時間枠：12ヶ月
|
12ヶ月
|
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6 か月時点での OBE-COACH プログラムの順守。前月の 1 週間あたりの被験者からの回答を伴う質問 (IRIADE から送信) の平均割合によって評価されます。
時間枠：6ヶ月
|
6ヶ月
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過去 6 か月間の Web フォーカス グループへの参加数によって評価される、6 か月時点での OBE-COACH プログラムの順守。
時間枠：6ヶ月
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6ヶ月
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TFEQ21 アンケートで評価された 0 ～ 12 か月間の食物衝動性の変化
時間枠：12ヶ月
|
12ヶ月
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TFEQ21 アンケートで評価した 0 か月から 6 か月間の食物衝動性の変化
時間枠：6ヶ月
|
6ヶ月
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HADアンケートで測定された不安症状の0〜12か月間の進展（スコア0〜21）
時間枠：12ヶ月
|
12ヶ月
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Weight reduction of at least 5% between 0 and 6 months.
時間枠：6 months
|
Weight, in Kg, measured in the same conditon at baseline and 6 months. |
6 months
|
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Weight change between 0 and 6 months
時間枠：6 months
|
Weight, in Kg, measured in the same conditon at baseline and 6 months. |
6 months
|
|
Weight change between 0 and 12 months
時間枠：12 months
|
Weight, in Kg, measured in the same conditon at baseline and 12 months. |
12 months
|
|
Waist change between 0 and 6 months
時間枠：6 months
|
Waist, in cm, measured midway between the last ribs and the anterior superior iliac crest |
6 months
|
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Waist change between 0 and 12 months
時間枠：12 months
|
Waist, in cm, measured midway between the last ribs and the anterior superior iliac crest |
12 months
|
|
Triglycerids change between 0 and 12 months
時間枠：12 months
|
Plasma fasting levels of triglycerides in g/L |
12 months
|
|
HDL cholesterol change between 0 and 12 months
時間枠：12 months
|
Plasma fasting levels of HDL cholesterol in g/L |
12 months
|
|
LDL cholesterol change between 0 and 12 months
時間枠：12 months
|
Plasma fasting levels of LDL cholesterol in g/L |
12 months
|
|
non-HDL cholesterol change between 0 and 12 months
時間枠：12 months
|
Plasma fasting levels of non-HDL cholesterol in g/L (total cholesterol less HDL-C) |
12 months
|
|
Blood glucose change between 0 and 12 months
時間枠：12 months
|
Plasma fasting levels of glucose in g/L |
12 months
|
|
HbA1c change between 0 and 12 months
時間枠：12 months
|
Plasma fasting levels of HbA1c in percentage |
12 months
|
|
Systolic blood pressure change between 0 and 12 months
時間枠：12 months
|
Systolic blood pressure in mmHg as the average of the last 2 automatic measurements out of 3 taken at the level of one arm and spaced about 2 min in the cabinet or by the patient with the auto-tensiometer |
12 months
|
|
Diastolic blood pressure change between 0 and 12 months
時間枠：12 months
|
Diastolic blood pressure in mmHg as the average of the last 2 automatic measurements out of 3 taken at the level of one arm and spaced about 2 min in the cabinet or by the patient with the auto-tensiometer |
12 months
|
|
Triglycerids change between 0 and 6 months
時間枠：6 months
|
Plasma fasting levels of triglycerides in g/L |
6 months
|
|
HDL cholesterol change between 0 and 6 months
時間枠：6 months
|
Plasma fasting levels of HDL cholesterol in g/L |
6 months
|
|
LDL cholesterol change between 0 and 6 months
時間枠：6 months
|
Plasma fasting levels of LDL cholesterol in g/L |
6 months
|
|
non-HDL cholesterol change between 0 and 6 months
時間枠：6 months
|
Plasma fasting levels of non-HDL cholesterol in g/L (total cholesterol less HDL-C) |
6 months
|
|
Blood glucose change between 0 and 6 months
時間枠：6 months
|
Plasma fasting levels of glucose in g/L |
6 months
|
|
HbA1c change between 0 and 6 months
時間枠：6 months
|
Plasma fasting levels of HbA1c in percentage |
6 months
|
|
Systolic blood pressure change between 0 and 6 months
時間枠：6 months
|
Systolic blood pressure in mmHg as the average of the last 2 automatic measurements out of 3 taken at the level of one arm and spaced about 2 min in the cabinet or by the patient with the auto-tensiometer |
6 months
|
|
Diastolic blood pressure change between 0 and 6 months
時間枠：6 months
|
Diastolic blood pressure in mmHg as the average of the last 2 automatic measurements out of 3 taken at the level of one arm and spaced about 2 min in the cabinet or by the patient with the auto-tensiometer |
6 months
|
|
Change in adherence to the Mediterranean diet : Score PREDIMED
時間枠：12 months
|
Change between 0 and 12 months of adherence to mediterranean diet,evaluated by the dietetic score PREDIMED (validated checklist of 14 items). Higher scores indicate greater adherence to the diet assigned |
12 months
|
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Change in adherence to the Mediterranean diet : fruits and vegetables consumption
時間枠：12 months
|
Change between 0 and 12 months in terms of perrcentage of consumption of fruits and vegetables on the recommended 400 g/day |
12 months
|
|
Change in adherence to the Mediterranean diet : Score PREDIMED
時間枠：6 months
|
Change between 0 and 6 months of adherence to mediterranean diet,evaluated by the dietetic score PREDIMED (validated checklist of 14 items). Higher scores indicate greater adherence to the diet assigned |
6 months
|
|
Change in adherence to the Mediterranean diet : fruits and vegetables consumption
時間枠：6 months
|
Change between 0 and 6 months in terms of percentage of consumption of fruits and vegetables on the recommended 400 g/day |
6 months
|
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Change between 0 and 12 months of Energy intake
時間枠：12 months
|
Energy intake, in Kcal/day, evaluated with the validated NAQA questionnaire |
12 months
|
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Change between 0 and 12 months of cholesterol intake
時間枠：12 months
|
Cholesterol intake, in mg/day, evaluated with the validated NAQA questionnaire |
12 months
|
協力者と研究者
捜査官
- 主任研究者：Marylou Para, MD, PhD、Assistance Publique - Hôpitaux de Paris
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
キーワード
その他の研究ID番号
- K160908J
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.
Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
IPD 共有時間枠
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
IPD 共有アクセス基準
Researchers who provide a methodologically sound proposal
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。