Lifestyle Changes Through Exercise and Nutrition (LEAN)
2018年6月4日 更新者：Robert L. Newton, Jr.、Pennington Biomedical Research Center
The Lifestyle Changes Through Exercise and Nutrition (LEAN) Project
The goal of The LEAN project intervention is to promote weight loss, healthy dietary habits, increased physical activity, improved blood glucose and cholesterol, and weight related quality of life in obese African American adults through a sustainable, technology enhanced, church-based program.
調査の概要
詳細な説明
The LEAN Project is a community-based weight loss program that is delivered through churches serving lower-income, obese, African American adults.
The intervention will involve training community health coaches to deliver the intervention.
These community health coaches will be individuals who are members of the church and who are willing to be trained on how to deliver behaviorally-based, empirically proven, lifestyle change interventions.
These community health coaches will be trained by the staff at Pennington Biomedical, who have experience training and delivering these types of interventions.
The community health coaches will deliver the intervention through their respective church after being trained.
Weekly text messages will be sent to participants in order to supplement the intervention sessions and provide support.
The primary aim is to determine if the trained community health coach church-based intervention will result in significant weight loss.
Secondary aims will assess blood glucose, cholesterol, physical activity, food intake, and weight related quality of life.
研究の種類
介入
入学 (実際)
97
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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Louisiana
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Baton Rouge、Louisiana、アメリカ、70808
- Pennington Biomedical Research Center
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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～75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:
- self-identify as African American
- a member of a participating church
- age 18-75 years old
- BMI > 30
- own a mobile phone with text message capabilities
- at risk for diabetes (diagnosed nuclear family member or gestational diabetes) or diagnosed with type 2 diabetes
- willing to provide written informed consent
- willing to change diet, physical activity and weight
- able to participate in face-face counselling sessions as scheduled
- low to moderate cardiovascular disease risk
Exclusion Criteria:
- currently participating in a weight loss program
- currently using weight loss medication or have lost weight (>10 lbs in last year)
- planning to move from the area within the next year
- given birth within the past year, are currently pregnant or plan to become pregnant within the next year
- planning to have bariatric surgery within 2 years
- history of major depression, suicidal behavior or eating disorder
- hospitalization for a mental disorder or substance abuse in the last year
- have cancer or had cancer within the past 5 years.
- serious heart problems such as arrhythmias, cardiomyopathy, congestive heart failure
- stroke or heart attack in the last six months
- high blood pressure [systolic ≥160, or diastolic ≥100]
- chronic inflammatory conditions, including but not limited to severe arthritis, lupus, or inflammatory bowel disease
- diseases that are life threatening or that can interfere with or be aggravated by exercise or weight loss
- unwilling or unable to provide informed consent
- physician's or principal investigator's decision to exclude
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：ランダム化
- 介入モデル：クロスオーバー割り当て
- 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：Weight loss intervention
Churches randomized to the intervention condition will receive the community health coach delivered church based intervention for 6 months followed by 6 months of weight maintenance.
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The intervention will involve utilizing trained community health coaches to deliver the weight loss intervention.
There will be 10 group based sessions conducted at each church over 6 months.
Session frequency will be 4 weekly sessions (4) for the first month, bimonthly sessions for 2 months (4) and monthly sessions for 2 months (2).
The study is based upon weight loss strategies that have been utilized in the Diabetes Prevention Program.
The group sessions will be augmented by utilizing text messages.
The text messages will be delivered weekly and three types of messages will be delivered: 1) lesson content, 2) motivational, 3) behavioral prompts.
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実験的：Delayed Treatment Control Group
Churches in the delayed treatment control condition will receive information on various health topics relevant to African Americans, such as strokes, lupus, sickle cell, etc. via text message during the first six months.
Participants in this group will not receive any behavioral strategies designed to alter weight, physical activity, or diet during this time.
They will receive the community health coach delivered church based weight loss intervention after 6 months.
|
The intervention will involve utilizing trained community health coaches to deliver the weight loss intervention.
There will be 10 group based sessions conducted at each church over 6 months.
Session frequency will be 4 weekly sessions (4) for the first month, bimonthly sessions for 2 months (4) and monthly sessions for 2 months (2).
The study is based upon weight loss strategies that have been utilized in the Diabetes Prevention Program.
The group sessions will be augmented by utilizing text messages.
The text messages will be delivered weekly and three types of messages will be delivered: 1) lesson content, 2) motivational, 3) behavioral prompts.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percent weight loss
時間枠：Month 6 and Year 1
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Percent weight loss will be calculated at 6 and 12 months.
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Month 6 and Year 1
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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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Change in Body Fat Percentage
時間枠：Screening, Month 6 and Year 1
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The participant's body fat percentage is measured using the portable Tanita Body Composition Analyzer (SC-240).
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Screening, Month 6 and Year 1
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Change in Blood Glucose
時間枠：Screening, Month 6 and Year 1
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The Alere Cholestech LDX® Analyzer is engineered to provide accurate, actionable, and readily accessible glucose testing results.
The Cholestech uses fingerstick sampling and small sample size (40μL) that makes results less time consuming and easy to obtain.
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Screening, Month 6 and Year 1
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Change in Blood Pressure
時間枠：Screening, Month 6 and Year 1
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Blood pressure will be measured using an automatic blood pressure cuff (Omeron, Model BP710 or similar).
Participants will rest for approximately 5 minutes prior to blood pressure measurement to ensure accurate at rest reading.
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Screening, Month 6 and Year 1
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Change in Food Intake
時間枠：Screening, Month 6 and Year 1
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The National Cancer Institute (NCI) fat screener estimates the percentage of energy from fat by asking patients to report the frequency of consuming specific foods over the past 12 months.
A standard 7-item fruit and vegetable screener developed by the NCI and National 5 a Day Program grantees asks how often fruit and vegetables were consumed in the past month.
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Screening, Month 6 and Year 1
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Change in Physical activity
時間枠：Screening, Month 6 and Year 1
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The International Physical Activity Questionnaire (IPAQ) questionnaire is a self-report measure of physical activity.
The metabolic equivalent task (MET) minutes in each domain of leisure time activity, that is, sedentary, light, moderate, and vigorous intensity, will be calculated.
The IPAQ has been shown to be a reliable and valid measure of physical activity and has been sensitive to changes in physical activity resulting from intervention programs.
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Screening, Month 6 and Year 1
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Change in Quality of Life
時間枠：Screening, Month 6 and Year 1
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. Each participant's quality of life will be assessed using the Impact of Weight on Quality of Life Survey.
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Screening, Month 6 and Year 1
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Satisfaction Questionnaire
時間枠：Month 6 and Year 1
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Each participant's satisfaction with the different elements of the study, including the community health coaches, the intervention, and the text messages, will be measured using a questionnaire developed by the investigators.
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Month 6 and Year 1
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Change in Blood Cholesterol
時間枠：Screening, Month 6 and Year 1
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The Alere Cholestech LDX® Analyzer is engineered to provide accurate, actionable, and readily accessible cholesterol testing results.
The Cholestech uses fingerstick sampling and small sample size (40μL) that makes results less time consuming and easy to obtain.
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Screening, Month 6 and Year 1
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Change in Pulse
時間枠：Screening, Month 6 and Year 1
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Pulse will be measured using an automatic blood pressure cuff (Omeron, Model BP710 or similar).
Participants will rest for approximately 5 minutes prior to pulse measurement to ensure accurate at rest reading.
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Screening, Month 6 and Year 1
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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。
捜査官
- 主任研究者：Robert L Newton, Jr., PhD、Pennington Biomedical Research Center
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Nguyen T, Irwin ML, Dewan AT, Cartmel B, Harrigan M, Ferrucci LM, Sanft T, Li F, Lu L, Salinas YD. Examining the effect of obesity-associated gene variants on breast cancer survivors in a randomized weight loss intervention. Breast Cancer Res Treat. 2021 Jun;187(2):487-497. doi: 10.1007/s10549-021-06151-5. Epub 2021 Mar 6.
- Newton RL Jr, Carter LA, Johnson W, Zhang D, Larrivee S, Kennedy BM, Harris M, Hsia DS. A Church-Based Weight Loss Intervention in African American Adults using Text Messages (LEAN Study): Cluster Randomized Controlled Trial. J Med Internet Res. 2018 Aug 24;20(8):e256. doi: 10.2196/jmir.9816.
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 (実際)
2016年6月1日
一次修了 (実際)
2017年9月23日
研究の完了 (実際)
2017年9月23日
試験登録日
最初に提出
2016年7月7日
QC基準を満たした最初の提出物
2016年8月8日
最初の投稿 (見積もり)
2016年8月11日
学習記録の更新
投稿された最後の更新 (実際)
2018年6月6日
QC基準を満たした最後の更新が送信されました
2018年6月4日
最終確認日
2018年6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
- PBRC 2016-018
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?
いいえ
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