Foundations of Fitness Program Pilot
2019年7月8日 更新者：Auden McClure、Dartmouth-Hitchcock Medical Center
Foundations of Fitness: A Clinic-Community Partnership to Address Pediatric Obesity
Approximately 17% of US children have obesity resulting in significant childhood co-morbidities and increased lifetime risk of adult obesity, diabetes, cardiovascular disease and cancer.
Guidelines recommend intensive lifestyle programs as first-line treatment, yet few pediatric practices are equipped to provide this.
Clinical-community partnerships are well-positioned to address this care gap.
This proposal aims to assess whether a community-delivered lifestyle program offered in adjunct to primary care obesity management is feasible, acceptable, effective, and easily implemented in a rural care setting.
In this study, approximately 40 children aged 7-13 years old and their caregiver pairs will be recruited from a primary care pediatric clinic.
Child-adult dyads will participate in a 24-week program that includes 2 phases, a 12-week usual care phase and a 12-week intervention phase.
The intervention phase will include bi-weekly meetings of a community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change.
A mixed-methods approach using qualitative interviews and study questionnaires, combined with objective measures of adiposity and fitness will assess study outcomes.
調査の概要
研究の種類
介入
入学 (実際)
29
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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New Hampshire
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Lebanon、New Hampshire、アメリカ、03756
- Dartmouth-Hitchcock Medical 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
7年～13年 (子)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Age 7-13 years;
- BMI% ≥85th%;
- Regional pediatric medical home patient;
- English speaking child and parent/caregiver;
Exclusion Criteria:
- Physical or developmental limitation to participation as determined by referring provider
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：非ランダム化
- 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：7-10 years old
Children-caregiver pairs will participate in a 24-week pilot that includes 2 phases, 12 weeks of usual care, followed by 12 weeks of Foundations of Fitness Program.
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The Foundations of Fitness Program is a 12 week, bi-weekly community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change, components supported by USPSTF evidence review.
Class sessions, which involve both parent/caregiver and child will include structured fitness activities, hands on nutrition, cooking, shopping and meal planning and facilitated discussions about goal setting, self-monitoring, stimulus control and healthy homes and families.
Content will be offered in a context that supports self-esteem and behavior change.
The program was developed by the Carter Community Building Association (CCBA) in collaboration with the Dartmouth-Hitchcock Weight & Wellness Center research core.
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実験的：11-13 years old
Children-caregiver pairs will participate in a 24-week pilot that includes 2 phases, 12 weeks of usual care, followed by 12 weeks of Foundations of Fitness Program.
|
The Foundations of Fitness Program is a 12 week, bi-weekly community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change, components supported by USPSTF evidence review.
Class sessions, which involve both parent/caregiver and child will include structured fitness activities, hands on nutrition, cooking, shopping and meal planning and facilitated discussions about goal setting, self-monitoring, stimulus control and healthy homes and families.
Content will be offered in a context that supports self-esteem and behavior change.
The program was developed by the Carter Community Building Association (CCBA) in collaboration with the Dartmouth-Hitchcock Weight & Wellness Center research core.
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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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Program Feasibility based on program attendance and completion of assessments to determine if children are willing and interested in to attending a fitness program.
時間枠：24 weeks
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Programmatic feasibility will be defined as delivery of 100% of the sessions with 80% of children attending ≥75% of sessions and 80% completing pre- and post-assessments.
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24 weeks
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Program Acceptability based on interviews evaluating the appropriateness of the pilot and assessing strengths/weaknesses.
時間枠：24 weeks
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Program acceptability will be assessed through semi-structured participant interviews ensuring the appropriateness of the pilot and assessing strengths/weaknesses.
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24 weeks
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Program Eligibility rate
時間枠：24 weeks
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Calculated using the following formula: [# screen positive / # screened for inclusion].
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24 weeks
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Program Enrollment rate
時間枠：24 weeks
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Calculated using the following formula: [# enrolled / (# screen positive & eligible)].
We will assess reasons for dropout/non-adherence.
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24 weeks
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Program Completion rate
時間枠：24 weeks
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Calculated using the following formula: (# completing all sessions / # enrolled).
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24 weeks
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Assessment Completion rate
時間枠：24 weeks
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Calculated using the following formula: (# completing all assessments / # enrolled).
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24 weeks
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Participant Satisfaction Survey
時間枠：24 weeks
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A 12 item survey at program conclusion will assess patient satisfaction with program elements (overall, class sessions, staff, assessments) using Likert scales (1-5 point scale - very dissatisfied=1 to very satisfied=5).
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24 weeks
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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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Body Mass Index Percentile
時間枠：48 weeks
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Height (cm) and Weight (kg) will be used to calculate body mass index (kg/m^2) and then BMI percentile (%) using Center for Disease Control 2000 standards.
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48 weeks
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Strength Assessment
時間枠：24 weeks
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Assessed through 5 exercises including: leg extension, leg curl, lap pull down, shoulder press, chest press.
Units for all are number of repetitions per minute at a fixed mass (lbs).
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24 weeks
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Health Habits Survey
時間枠：24 weeks
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The Weight & Wellness Center Health Habits Survey assesses diet, activity, media and sleep behaviors through 46 individual survey questions with variable response categories (for example, overall physical activity is assessed using a 0-5 point Likert scale with higher score related to better physical activity level: " Overall my physical activity level is": Poor=0 - Excellent=5)
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24 weeks
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Subjective Health and Quality of Life Score
時間枠：24 weeks
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The Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Health 7 survey (child and parent proxy) is a 7-question survey (Score 7-35) capturing physical, mental, and social aspects of quality of life using Likert scales (1-5 point scale: poor/never=1 to excellent/always=5). Higher score indicates more positive perceptions of overall health.
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24 weeks
|
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Sense of Belonging in Fitness Program Score
時間枠：24 weeks
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The Anderson-Butcher and Conroy Sense of Belonging survey is a 5-item questionnaire measuring sense of belonging experienced by children participating in a Fitness Program using Likert scale (1-4 point scale: NO!=1, no=2, yes=3, and YES!=4).
Total Score Range 5-20: A higher score indicates a greater sense of belonging.
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24 weeks
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Self Esteem Score
時間枠：24 weeks
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The Rosenberg Self-Esteem survey is a 10-item questionnaire measuring self-esteem of children participating in a Fitness Program using Likert scale (0-3 point scale: Strongly disagree=0 to Strongly agree=3).
Total Score Range 0-30: Higher scores indicate greater self-esteem.
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24 weeks
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Physical Activity Score
時間枠：24 weeks
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The Patient Reported Outcomes Measurement Information Systems (PROMIS) is a short form 4-question survey (Score 4-20) assessing physical activity over the past seven days using Likert scales (1-5 point scale: No days=1, 1 day=2, 2-3 days=3, 4-5 days=4, and 6-7 days=5).
Higher score indicates higher levels of physical activity.
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24 weeks
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Cardio-capacity
時間枠：24 weeks
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Distance (m) on treadmill at 65% of max heart rate.
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24 weeks
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Heart Rate
時間枠：24 weeks
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Resting and recovery heart rate (BPM) measured before and after treadmill test.
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24 weeks
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Blood Pressure
時間枠：24 weeks
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Resting and recovery systolic and diastolic Blood pressure (mmHg) measured before and after treadmill test.
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24 weeks
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Waist Circumference
時間枠：24 weeks
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Waist circumference will be measured (cm)
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24 weeks
|
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Perceived Athletic Competence Score
時間枠：24 weeks
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The Harter Self-Perception Profile for Children is a short form 6-question survey (score 1-4) assessing athletic competence using a two-choice format with option then of checking "Sort of True for Me" or "Really True for Me" (A score of 1 indicates lowest and a score of 4 highest level of perceived athletic competence).
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24 weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Staff program adoption
時間枠：24 weeks
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Staff program adoption will be assessed using semi-structured interviews assessing staff experience with workflow and adoption of Foundations of Fitness Program.
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24 weeks
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Fidelity to planned program
時間枠：24 weeks
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We will assess percent of planned class sessions and planned outcome assessments that were administered.
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24 weeks
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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：Auden C McClure, MD MPH、Dartmouth-Hitchcock Medical Center
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)
2018年7月12日
一次修了 (実際)
2019年6月12日
研究の完了 (実際)
2019年6月12日
試験登録日
最初に提出
2018年7月18日
QC基準を満たした最初の提出物
2018年8月7日
最初の投稿 (実際)
2018年8月9日
学習記録の更新
投稿された最後の更新 (実際)
2019年7月10日
QC基準を満たした最後の更新が送信されました
2019年7月8日
最終確認日
2019年7月1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。