The Childhood Health and Asthma Management Program (CHAMP)
Overweight and obese (OV/OB) children with asthma are at-risk for particularly poor health outcomes including poor asthma control, higher risk of asthma-related symptoms, and decreased quality of life. Weight loss reduces asthma symptoms, improves lung function, and increases quality of life among OV/OB adults with asthma. Little research has examined the impact of weight loss on asthma outcomes in OV/OB youth, and there is little research examining weight management interventions in OV/OB children with asthma. Behavioral family-based lifestyle interventions are successful in producing weight loss in children. To our knowledge, however, there has been no systematic effort to examine the impact of these interventions on weight status and asthma outcomes, nor has there been an effort to tailor these programs to the specific needs of OV/OB children with asthma.
The aims of this study are to develop and test the Childhood Health and Asthma Management Program (CHAMP), a behavioral family-based lifestyle intervention that is community-based to promote successful weight and asthma management in OV/OB children with asthma. The investigators propose to develop an intervention based on a previously developed behavioral family-based lifestyle intervention that was community-based and produced positive long term weight status changes in OV/OB children and tailor it for OV/OB children with asthma to create CHAMP. CHAMP will include asthma education and targeting unique barriers to weight management in OV/OB children with asthma. A focus group will be conducted with OV/OB children with asthma, ages 6-12, and their parent(s). Then a pilot randomized controlled trial of the CHAMP intervention with 32 OV/OB children with asthma, ages 6-12 years, and their parent(s). Families will be randomly assigned to CHAMP or a health education group. The investigators hypothesize that participants in CHAMP will have more effective weight and asthma management and child asthma outcomes compared to those in the general education group.
調査の概要
詳細な説明
At the first appointment the following information will be collected to determine eligibility for the research study. If participation is determined, a second visit will be scheduled at the end of the visit or the potential participant will be provided with a suggestion to speak with their primary care physician for other treatment options.
A measurement of height and weight will be taken, questionnaires regarding medical history, including asthma symptoms and control, and questionnaires about family background information (e.g., family income, size of family, employment, and marital status).
In addition, information concerning the following conditions will be collected and may exclude participation: dietary restriction or a medical condition that makes mild energy restriction or physical activity potentially dangerous, diagnosed with a major psychiatric disorder such as schizophrenia, bipolar disorder or autism, has used systemic corticosteroids within 3 months, or prescription weight loss drugs within 6 months.
The second appointment will happen one to two weeks before the start of the treatment program. During this visit the following will happen:
A measurement of height and weight, and waistline, questionnaires and complete an interview about asthma management and quality of life, and a test for lung function both pre and post albuterol. At the end of the visit an accelerometer will be provided to wear for 7 days in a row. The accelerometer will measure how much exercise is done each day.
At the end of this visit, the participant will be randomly assignment to either the experimental Childhood Health and Asthma Management Program (CHAMP) group or the health education group.
The CHAMP group will receive tailored asthma education and behavioral skills focused on improving asthma and weight management.
The health education group will receive tailored asthma education and general health education on a variety of topics.
Each of the treatment programs will last for 6 months.
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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Florida
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Gainesville、Florida、アメリカ、32610
- University of Florida
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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:
- speaks English;
has a physician-verified persistent asthma diagnosis or by indicating on a screening questionnaire that they
- having a current prescription for a controller medication (e.g. Fluticasone), or
- demonstrating any of the following symptom frequency in the previous month: (I) daytime asthma symptoms more than two days a week, (II) nighttime awakenings due to asthma more than times a month, (III) short-acting beta agonist use 2 days a week, (IV) normal activity limitation, (V) oral steroid use 2 times a year, (VI) emergency department visit due to asthma in past year;
- has a BMI at or above the 85th percentile for age and gender norms as published by the CDC.
Participating parents of legal guardians must:
- live in the same home with the child;
- speak English;
- be aged 75 or younger. There is no BMI requirement for participating parents/legal guardians.
Exclusion Criteria:
- child or parent has dietary restriction or a medical condition that contraindicates mild energy restriction or physical activity (history of musculo-skeletal condition that limits walking, heart condition, chronic lung diseases limiting physical activity, current participation in commercial weight loss program);
- use of antipsychotic agents, monoamine oxidase inhibitors, systemic corticosteroids within 3 months, or prescription weight loss drugs within 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：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：CHAMP
Families assigned to this arm will receive tailored asthma education and behavioral skills focused on improving asthma and weight management.
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Families assigned to this arm will receive tailored asthma education and behavioral skills focused on improving asthma and weight management.
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アクティブコンパレータ：Health education
Families assigned to this arm will receive tailored asthma education and general health education on a variety of topics.
|
Families assigned to this arm will receive tailored asthma education and general health education on a variety of topics.
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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 |
|---|---|
|
Spirometry will be used to test the change in lung function from baseline, 4 months, and 10 months
時間枠：Change from Baseline, 4 months, and 10 months
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Change from Baseline, 4 months, and 10 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Body Mass Index will be calculated to test the change in weight from baseline, 4 months, and 10 months
時間枠：Change from Baseline, 4 months, and 10 months
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Change from Baseline, 4 months, and 10 months
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The Asthma Control Test questionnaire will be calculated to test the change in asthma control from baseline, 4 months, and 10 months
時間枠：Change from Baseline, 4 months, and 10 months
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Change from Baseline, 4 months, and 10 months
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The Family Asthma Management System Scale semi-structured interview will be used to test the change in family asthma management from baseline, 4 months, and 10 months.
時間枠：Change from Baseline, 4 months, and 10 months
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Change from Baseline, 4 months, and 10 months
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The Standardised Paediatric Asthma Quality of Life Questionnaire interview will be used to test the change in quality of life from baseline, 4 months, and 10 months.
時間枠：Change from Baseline, 4 months, and 10 months
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Change from Baseline, 4 months, and 10 months
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The Block Foods questionnaire will be used to test the change in dietary intake from baseline, 4 months, and 10 months.
時間枠：Change from Baseline, 4 months, and 10 months
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Change from Baseline, 4 months, and 10 months
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Objectively monitored physical activity will be used to test the change in physical activity from baseline, 4 months, and 10 months.
時間枠：Change from Baseline, 4 months, and 10 months
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Change from Baseline, 4 months, and 10 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：David A Fedele, Ph.D>、University of Florida
研究記録日
主要日程の研究
研究開始 (実際)
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 (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
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。