退役軍人におけるストレス関連の摂食行動の根底にある神経生物学に対する運動の影響
The purpose of this study is to learn more about how common lifestyle interventions, such as exercise, affect how our brains respond to performing thinking tasks and to viewing pictures of foods and various other objects. The investigators are also interested in how changes in hormones that might be different in men and women could affect how lifestyle interventions change these brain responses.
調査の概要
詳細な説明
The purpose of this study is to learn more about how common lifestyle interventions, such as exercise, affect how our brains respond to performing thinking tasks and to viewing pictures of foods and various other objects. The investigators are also interested in how changes in hormones that might be different in men and women could affect how lifestyle interventions change these brain responses. This will help us to better understand how different lifestyle interventions affect the brain and how this might relate to various behaviors. Eligible participants will be asked to complete 2 study days before and again after a 12-week intervention period, during which they will either continue with usual activities or be asked to complete exercise sessions four times per week. They will be randomly assigned to one of these conditions (exercise or not) and will not be able to choose their group assignment.
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：Kristina T Legget, PhD
- 電話番号：(720) 724-5809
- メール：kristina.legget@va.gov
研究場所
-
-
Colorado
-
Aurora、Colorado、アメリカ、80045-7211
- 募集
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
コンタクト：
- Kristina T Legget, PhD
- 電話番号：(720) 724-5809
- メール：kristina.legget@va.gov
-
主任研究者：
- Kristina T. Legget, PhD
-
-
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:
- Veteran
- Body mass index (BMI) of 25 or greater
- Physically inactive
- Able to attend study visits in person in Aurora, CO
Exclusion Criteria:
- Currently pregnant
- History of bariatric surgery
- Current eating disorder
- Current treatment with appetite-altering medications (e.g., glucagon-like peptide-1 (GLP-1) agonists)
- Contraindication to MRI (weight > 500 pounds (lbs); claustrophobia; metal or electronic devices in the body)
- Cardiovascular disease, chronic kidney disease, pulmonary disease, or diabetes
- Unable to exercise due to cardiac, pulmonary, neurologic, or orthopedic reasons
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Exercise
Participants will complete 4 aerobic exercise training sessions per week for 12 weeks. The exercise program will begin at 15 minutes per session and duration will be gradually increased by 5 minutes each week until participants reach 30 minutes per session (with 5 min warm-up and cool-down). Exercise will be performed at a "moderate" intensity, which will be about 60-70% of your predicted maximal level. Participants will meet with study personnel once per week. |
12 weeks of aerobic exercise, with 4 sessions per week. |
|
介入なし：Usual activity
Participants will keep doing what they usually do for the 12-week intervention period. They will be asked not to change their usual physical activity levels during this period. They will meet with study personnel once per week |
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 |
|---|---|---|
|
Percent change in blood oxygen level dependent (BOLD) response to visual food cues as measured by functional magnetic resonance imaging (fMRI)
時間枠：Baseline, 12 weeks
|
Percent change in blood oxygen level dependent (BOLD) response from baseline to after the 12-week intervention period while viewing visual food cues. The primary contrast of interest is the comparison of high-calorie food images to nonfood object images. |
Baseline, 12 weeks
|
|
Change in serum cortisol response to counting task
時間枠：Baseline, 12 weeks
|
Change from baseline to after the 12-week intervention period in serum cortisol levels (micrograms per deciliter (mcg/dL)) throughout a counting task involving mental math (measured as area under the curve). |
Baseline, 12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in heart rate response to counting task
時間枠：Baseline, 12 weeks
|
Change from baseline to after the 12-week intervention period in heart rate (measured by photoplethysmograph; aggregated in 1 min intervals) throughout a counting task involving mental math (measured as area under the curve). |
Baseline, 12 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in percent body fat
時間枠：Baseline, 12 weeks
|
Change in percent body fat, as measured by dual-energy x-ray absorptiometry, from baseline to after the 12-week intervention period. |
Baseline, 12 weeks
|
|
Percent change in body weight
時間枠：Baseline, 12 weeks
|
Percent change in body weight (kilograms) from baseline to after the 12-week intervention period. |
Baseline, 12 weeks
|
協力者と研究者
捜査官
- 主任研究者：Kristina T. Legget, PhD、Rocky Mountain Regional VA Medical Center, Aurora, CO
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
- ENDA-009-24S
- I01CX002752 (米国 NIH グラント/契約)
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
As some journals now require authors to provide access to data, de-identified, anonymized data sets will be created after study results are published, and made available upon request for general research purposes, based on availability of resources. No proprietary data will be made publicly available. Sufficient data and descriptors will be made available to confirm conclusions in resulting publications and duplicate statistical analyses.
IPD 共有時間枠
Data will become available after publication of study results and be available at least 3 years beyond the completion of the study.
IPD 共有アクセス基準
Data will be made available upon request for general research purposes, based on availability of resources.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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
米国で製造され、米国から輸出された製品。
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。