Translational Study for Obesity Management in Mexican Adults Using the "Group Lifestyle Balance Program" (GLBOMEX)
2016年5月20日 更新者：Rolando Giovanni Díaz Zavala、Universidad de Sonora
Translational Study for Overweight and Obesity Management in Adults Using the "Group Lifestyle Balance Program" in Primary Care Clinics and Public Hospitals From Sonora, México
Obesity is the main modifiable risk factor for the development of chronic diseases in Mexico.
Several randomized controlled trials have shown that intensive lifestyle programs are efficacious for the management of obesity.
These programs include frequent sessions (14 or more contacts in the first 6 months) focused on diet and physical activity and use a behavior change protocol.
In Mexico most primary care clinics and public hospitals apply traditional treatments for obesity management, which have limited effect on weight loss.
This study would provide scientific evidence for an effective model for obesity management.
Objective.
The purpose of this study is to evaluate the effectiveness of the "Group Lifestyle Balance Program" for overweight and obesity management in adults, in primary care clinics and public hospitals from Sonora.
This is a translational clinical study.
Healthcare providers from the participating clinics will be trained with the Group Lifestyle Balance Program before its implementation.
The primary outcome measurement is the change in body weight from baseline to 6 months and 12 months.
Changes in body mass index, waist circumference, systolic and diastolic blood pressure, depression, quality of life and stress scales will be measured in patients receiving the program before and 6 and 12 months after starting the program.
Additionally, biochemical parameters (fasting glucose, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, fasting insulin, Homeostatic Model Assessment- Insulin Resistance (HOMA-IR) and liver enzymes [Aspartate transaminase (AST), Alanine Aminotransferase (ALT)] will be evaluated from baseline to 12 months.
調査の概要
研究の種類
介入
入学 (実際)
258
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Sonora
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Hermosillo、Sonora、メキシコ、83000
- Centro de Promoción de Salud Nutricional (CPSN)
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Hermosillo、Sonora、メキシコ、83000
- Centro de Salud Urbano Dr. Domingo Olivares
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Hermosillo、Sonora、メキシコ、83000
- Hospital General del Estado de Sonora
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Hermosillo、Sonora、メキシコ、83000
- Hospital Ignacio Chávez
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Hermosillo、Sonora、メキシコ、83180
- Centro Avanzado de Atención a la Salud (CAAPS)
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Adults (>18 years of age and <65)
- Overweight or Obese (BMI >25 kg/m2 y <50 kg/m2)
- Availability and motivation to attend the intervention program
- Patients who would benefit from participating in the program according to the health providers
- Signing an informed consent
Exclusion Criteria:
- Medical conditions affecting body weight significantly
- Pregnancy or nursing
- Bariatric surgery
- Being unable to participate in regular moderate physical activity
- Blood pressure >160 mm/Hg
- HbA1c>9
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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：Group Lifestyle Balance Program
Participants will be assigned to an adaptation of the "Group Lifestyle Balance Program", a behavioral curriculum implemented in the Diabetes Prevention Program Study. The Group Lifestyle Balance Program will be provided weekly for the first 3.5 months, bi-weekly from 3.5 to 6 months and then monthly until 12 months. Health care providers will be trained for the implementation of the intervention. Additionally, participants will attend at least one monthly visit with a nutritionist (individually). The lifestyle objectives for participants will be as follows:
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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 |
時間枠 |
|---|---|
|
Change in body weight
時間枠：Change in body weight from baseline to 6 months and change in body weight from baseline to 12 months
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Change in body weight from baseline to 6 months and change in body weight from baseline to 12 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Change in waist circumference
時間枠：Change in waist circumference from baseline to 6 months and change in waist circumference from baseline to 12 months
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Change in waist circumference from baseline to 6 months and change in waist circumference from baseline to 12 months
|
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Change in body fat percentage
時間枠：Change in body fat percentage from baseline to 6 months and change in body fat percentage from baseline to 12 months
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Change in body fat percentage from baseline to 6 months and change in body fat percentage from baseline to 12 months
|
|
Change in the Beck Depression Inventory score
時間枠：Change in the Beck Depression Inventory score from baseline to 6 months and change in in the Beck Depression Inventory score from baseline to 12 months
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Change in the Beck Depression Inventory score from baseline to 6 months and change in in the Beck Depression Inventory score from baseline to 12 months
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Change in the Short Form-36 Health Survey score
時間枠：Change in the Short Form-36 Health Survey score from baseline to 6 months and change in the SF-36 Health Survey score from baseline to 12 months
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Change in the Short Form-36 Health Survey score from baseline to 6 months and change in the SF-36 Health Survey score from baseline to 12 months
|
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Change in the Perceived Stress Scale (PSS) -14 score
時間枠：Change in the Perceived Stress Scale (PSS) -14 score from baseline to 6 months and change in the Perceived Stress Scale PSS-14 score from baseline to 12 months
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Change in the Perceived Stress Scale (PSS) -14 score from baseline to 6 months and change in the Perceived Stress Scale PSS-14 score from baseline to 12 months
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Change in systolic and diastolic blood pressure
時間枠：Change in systolic and diastolic blood pressure from baseline to 6 months and change in systolic and diastolic blood pressure from baseline to 12 months
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Change in systolic and diastolic blood pressure from baseline to 6 months and change in systolic and diastolic blood pressure from baseline to 12 months
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Change in fasting glucose
時間枠：Change in fasting glucose from baseline to 12 months
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Change in fasting glucose from baseline to 12 months
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Change in total cholesterol
時間枠：Change in total colesterol from baseline to 12 months
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Change in total colesterol from baseline to 12 months
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Change in LDL-cholesterol
時間枠：Change in LDL-cholesterol from baseline to 12 months
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Change in LDL-cholesterol from baseline to 12 months
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Change in HDL-cholesterol
時間枠：Change in HDL-cholesterol from baseline to 12 months
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Change in HDL-cholesterol from baseline to 12 months
|
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Change in triglycerides
時間枠：Change in triglycerides from baseline to 12 months
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Change in triglycerides from baseline to 12 months
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Change in fasting insulin
時間枠：Change in fasting insulin from baseline to 12 months
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Change in fasting insulin from baseline to 12 months
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Change in HOMA-IR
時間枠：Change in HOMA-IR from baseline to 12 months
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Change in HOMA-IR from baseline to 12 months
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Change in liver enzymes [AST and ALT]
時間枠：Change in liver enzymes [AST and ALT] from baseline to 12 months
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Change in liver enzymes [AST and ALT] from baseline to 12 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Rolando G Díaz, Ph.D.、Universidad de Sonora
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年9月1日
一次修了 (予想される)
2017年4月1日
研究の完了 (予想される)
2017年4月1日
試験登録日
最初に提出
2015年8月25日
QC基準を満たした最初の提出物
2015年8月28日
最初の投稿 (見積もり)
2015年9月2日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年5月23日
QC基準を満たした最後の更新が送信されました
2016年5月20日
最終確認日
2016年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- DPPMEX-077
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。