若年成人の減量研究
若者の減量のための新しい介入
Obesity and cardiometabolic risks are significant public health issues, with about two-thirds of U.S. adults overweight or obese. Weight loss can prevent these health problems, but current lifestyle interventions have limited success. New, effective strategies are needed to address this rising issue at the population level. The goal of this clinical trial is to investigate how a behavioral intervention combined with technology impacts weight loss in young adults. The main questions it aims to answer are:
• How does the combination of behavioral intervention and technology influence weight loss in young adults?
調査の概要
詳細な説明
The study team is seeking volunteers to participate in a research study to help better understand how a behavioral intervention combined with technology may impact weight loss. Participation will span approximately 6 months. Participants will be required to attend up to 5 visits at the University of Chicago. Those visits will include daytime visits to a clinic involving fasted blood draws and completion of surveys. During the study, participants will regularly record their weight using a digital scale, input their daily food intake into a smartphone app, and wear a wrist activity monitor to track their physical activity. Participants will also be paired with a trained coach to guide and assist their progress over their 6 months of participation.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Olivia Hughes
- 電話番号：7737022348
- メール：bhughes8@bsd.uchicago.edu
研究場所
-
-
Illinois
-
Chicago、Illinois、アメリカ、60637
- 募集
- University of Chicago
-
主任研究者：
- Esra Tasali, MD
-
コンタクト：
- UChicago IRB
- 電話番号：773-702-6505
-
-
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:
- Overweight or obese (BMI 25.5- 34.9 kg/m2) men and women
- Ages 18 to 40 years
- Weight stable (no change >25 lbs in the past 3 months)
- Owns a smartphone and willing to install the study app
Exclusion Criteria:
- Presence of obstructive sleep apnea or history of any other sleep disorder.
- Irregular menses, menopausal symptoms or post-menopausal, currently pregnant, trying to get pregnant or nursing
- Regular travel across time zones
- Subjects who are currently following a weight loss regimen or any other special diet or exercise programs
- Increased fractional lean body mass (e.g., athletes)
- Unable to walk, using an assistive device for mobility, or any contraindications to exercise
- Diabetes
- Claustrophobia
- Excessive alcohol (>2 drinks/day) or caffeine (>300mg/day) intake, regular nicotine use, substance abuse.
- Abnormal findings on screening blood testing.
- Participants taking any prescription, over-the-counter drugs/supplements that can affect sleep or weight.
- Major psychiatric or any eating disorder, and any acute or chronic medical condition that increase the risk of interventions (e.g., heart disease)
- Any underlying disease likely to limit life span and/or increase risk of interventions including cardiovascular disease (e.g. unstable angina, heart failure requiring hospitalization in the past 6 months, significant heart block or arrhythmias, NYHA Class>2), pulmonary disease with dependence on oxygen or daily use of bronchodilators, cancer requiring treatment in the past 5 years unless the prognosis is considered good, active or chronic infection, thyroid disease and other endocrine disorders (e.g. Cushing syndrome, acromegaly), hepatitis or other chronic gastrointestinal disease (pancreatitis, inflammatory bowel disease), renal disease, significant anemia, recent surgery or significant abdominal surgery, major psychiatric or any eating disorder, acute coronary syndrome or stroke in the past 6 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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Lifestyle Intervention
Diet and exercise coaching |
All participants will receive diet and exercise goals and coaching. |
|
実験的：Lifestyle Intervention II
Diet and exercise coaching |
All participants will receive diet and exercise goals and coaching. |
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：Baseline and 6 months
|
Change in weight [kg] at 6 months. Weight will be measured by research staff during each visit in the morning in duplicate in the fasted state after voiding using calibrated digital scales, wearing a hospital gown. |
Baseline and 6 months
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Esra Tasali, MD、University of Chicago
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- IRB23-1677
- 1R01DK136214-01A1 (米国 NIH グラント/契約)
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。