PACE CALL: Weight Loss Study for Childhood Leukemia Survivors
PACE CALL: A Tailored Weight Management Program for Childhood ALL Survivors
調査の概要
詳細な説明
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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California
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La Jolla、California、アメリカ、92093
- UC San Diego
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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:
- 7 - 18 years old
- survived childhood acute lymphoblastic leukemia (defined as being off treatment for at least 2 years)
- greater than or equal to 85th percentile BMI-for-age and gender)
- read and speak English
- have a parent that reads and speaks English or Spanish
- willingness to attend assessments
- access to the Internet
Exclusion Criteria:
- any comorbidities of obesity that require immediate sub-specialist referral including pseudotumor cerebri, sleep apnea, and obesity hypoventilation syndrome
- any subject with a known disease of the liver, pancreas or small intestine that would adversely effect digestion or absorption of nutrients
- any pulmonary, cardiovascular, orthopedic, or musculoskeletal problem that would limit ability to adhere to moderate-level physical activity recommendations
- have a history of substance abuse or other psychiatric disorder that would impair compliance with the study protocol
- are using any medications which alter body weight
- are currently enrolled in another weight loss program
- in foster care
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：防止
- 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：PACE CALL/Fit4Life
Fit4Life intervention activities: Website: Provides weekly nutrition, physical activity, and weight loss information. Counseling Calls: Participants and their parents will get phone calls from their Health Coach to assess progress & problems. Health Coach Question & Answer: Participants will be assigned a Health Coach that they can contact at any time to ask questions or express any concerns. Text & Picture Messages: Participants will receive daily text messages to help remind them of being healthy. Messages will relate to the weekly topics and general checking in questions. Parent Materials: Parents will receive a packet of printed materials that relate to parenting skills regarding being a healthy role model for their child and healthy eating and exercise tips. |
The Fit4Life E intervention will be designed to promote weight loss and subsequent weight loss maintenance through the adoption and maintenance of improved eating, physical activity and sedentary behaviors in at risk for overweight and overweight adolescent survivors of ALL and their parent/guardian. the Fit4Life intervention will incorporate elements of the Chronic Care Model, including frequent phone and mail interactions, an initial in-person encounter to provide encouragement and initial patient-tailored counseling for obesity management, family-centered skill development to achieve healthy behavioral modification via goal setting, self-monitoring, and problem solving. The Fit4Life intervention includes: Web-based weight loss program Text and Picture messages Counseling Calls Health Coach |
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介入なし：Control
The Control group will receive monthly mailings on basic nutrition and physical activity information.
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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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BMI
時間枠：Baseline, 4 months
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To determine the impact of a weight loss intervention on BMI compared to a control group
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Baseline, 4 months
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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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Weight Loss Behaviors
時間枠：Baseline, 4 months
|
To determine the impact of a weight loss intervention vs. a control group on self-reported behavioral measures of diet and physical activity.
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Baseline, 4 months
|
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Metabolic Blood Measures
時間枠：Baseline, 4 months
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To determine the impact of a weight loss intervention vs. control on fasting serum insulin, fasting blood glucose, and blood lipid levels.
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Baseline, 4 months
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Psychosocial Mediators of Weight Loss Behaviors
時間枠：Baseline, 4 months
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To determine the impact of a weight loss intervention vs. control on psychosocial mediators of diet and physical activity behavior changes
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Baseline, 4 months
|
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Quality of Life
時間枠：Baseline, 4 months
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To determine the impace of a weight loss intervention vs. control on quality of life and depression.
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Baseline, 4 months
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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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。