Food, Fun, & Fitness Internet Program for Girls: Outcome Evaluation (FFFIPG)
2016年1月18日 更新者：Deborah Thompson、Baylor College of Medicine
Using Technology to Prevent Obesity Among African American Girls
The purpose of this project is to reduce health disparities in obesity risk among 8-10 year old African American girls using a culturally sensitive and developmentally appropriate internet-based program with no face-to-face interaction.
This study will conduct an outcome evaluation to test short and longer term effects on obesity risk.
調査の概要
詳細な説明
This research will conduct an outcome evaluation on a promising web based obesity prevention program for 8-10 year old African American girls.
A pilot study with 80 girls established its feasibility: recruitment goals were met; attrition rates were < 10%; logon rates to the online program were 74.5%; and statistically significant increases in fruit and vegetable consumption and time spent being physically active were observed.
The outcome evaluation will recruit 400 child-parent pairs to examine short and longer term effects of the program on obesity risk.
It will also conduct mediation analyses to examine pathways of effect.
At the end of the study, the web based program will be hosted on the CNRC web site.
Although the use of the internet as a method for changing health behavior is not new, the use of an internet program alone, with no face to face interaction, is novel.
This is one of the first programs to attempt this, particularly in an at-risk population.
研究の種類
介入
入学 (実際)
342
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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Texas
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Houston、Texas、アメリカ、77030
- Baylor College of Medicine
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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
8年～10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
女性
説明
Inclusion Criteria:
- 8-10 years old
- healthy
- African American
- parent willing to participate in data collection
- internet access
- personal email address
Exclusion Criteria:
- mental, physical, or medical conditions that limit fruit-vegetable consumption, physical activity, or ability to fully participate in the program and/or complete baseline and post assessment data collection
- taking medications that influence dietary behaviors, appetite, and/or physical activity
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：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：story plus behaviorial procedures
The girls randomized to this arm of the study will view an interactive story about 6 8-10 year old African American girls who seek to find clues to solve a mystery about the town in which they live.
The episodes will contain information about healthy nutrition and physical activity, as well as basic information about physical activity and kitchen safety tips, developmentally appropriate recipes, and portion sizes.
Girls randomized to this arm of the study will also engage in key behavior change procedures, such as goal setting, problem solving, and self monitoring.
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This is an 8 episode intervention, delivered entirely over the internet.
Each episode, girls will view an interactive story in which 6 8-10 year old African American characters attempt to solve a mystery about their town.
The online program will include information about healthy nutrition (i.e., consuming more fruit, vegetables, water) and physical activity.
There will be two groups; one group (the experimental group) will view the interactive story and participate in key behavior change procedures, such as personal goal setting, problem solving, and self monitoring activities.
The second group (the active comparator group) will view the online stories but will not engage in key behavior change procedures.
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アクティブコンパレータ：story only
The girls randomized to this arm of the study will view an interactive story about 6 8-10 year old African American girls who seek to find clues to solve a mystery about the town in which they live.
The episodes will contain information about healthy nutrition and physical activity, as well as basic information about physical activity and kitchen safety tips, developmentally appropriate recipes, and portion sizes.
Girls randomized to this arm of the study will not engage in key behavior change procedures, such as goal setting, problem solving, and self monitoring.
|
This is an 8 episode intervention, delivered entirely over the internet.
Each episode, girls will view an interactive story in which 6 8-10 year old African American characters attempt to solve a mystery about their town.
The online program will include information about healthy nutrition (i.e., consuming more fruit, vegetables, water) and physical activity.
There will be two groups; one group (the experimental group) will view the interactive story and participate in key behavior change procedures, such as personal goal setting, problem solving, and self monitoring activities.
The second group (the active comparator group) will view the online stories but will not engage in key behavior change procedures.
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介入なし：Wait list control
This group will participate in data collection only; after the 3rd data collection point, they will be given access to the intervention
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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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Body mass index percentile
時間枠：6 months
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height and weight will be used to calculate BMI percentile
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6 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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fruit and vegetable consumption
時間枠：3 months
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dietitian-assisted dietary recalls will be collected using the NDSR system; 2 recalls will be collected (1 week day and 1 weekend day)
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3 months
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physical activity
時間枠：3 months
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Accelerometers will be used to assess physical activity at each time point
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3 months
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self efficacy
時間枠：3 months
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Standard measures will be used to assess fruit, vegetable, water, and physical activity self efficacy
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3 months
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home availability
時間枠：3 months
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standard measures will be used to assess fruit, vegetable, and physical activity equipment home availability
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3 months
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asking behaviors
時間枠：3 months
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standard measures will be used to assess child fruit, vegetable, water, and physical activity asking behaviors
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3 months
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fruit and vegetable consumption
時間枠：6 months
|
dietitian-assisted dietary recalls will be collected using the NDSR system; 2 recalls will be collected at each time point (1 week day and 1 weekend day)
|
6 months
|
|
physical activity
時間枠：6 months
|
Accelerometers will be used to assess physical activity
|
6 months
|
|
self efficacy
時間枠：6 months
|
standard measures will be used to assess fruit, vegetable, water, and physical activity self efficacy
|
6 months
|
|
home availability
時間枠：6 months
|
standard measures will be used to assess fruit, vegetable, and physical activity equipment home availability
|
6 months
|
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asking behaviors
時間枠：6 months
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standard measures will be used to assess child fruit, vegetable, water, and physical activity asking behaviors
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6 months
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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：Deborah I Thompson, PhD、Baylor College of Medicine
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Callender C, Liu Y, Moore CE, Thompson D. The baseline characteristics of parents and African American girls in an online obesity prevention program: A feasibility study. Prev Med Rep. 2017 May 19;7:110-115. doi: 10.1016/j.pmedr.2017.05.011. eCollection 2017 Sep.
- Thompson D, Mahabir R, Bhatt R, Boutte C, Cantu D, Vazquez I, Callender C, Cullen K, Baranowski T, Liu Y, Walker C, Buday R. Butterfly Girls; promoting healthy diet and physical activity to young African American girls online: rationale and design. BMC Public Health. 2013 Aug 2;13:709. doi: 10.1186/1471-2458-13-709.
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
2012年1月1日
一次修了 (実際)
2015年5月1日
研究の完了 (実際)
2015年5月1日
試験登録日
最初に提出
2011年11月21日
QC基準を満たした最初の提出物
2011年11月28日
最初の投稿 (見積もり)
2011年11月30日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年1月20日
QC基準を満たした最後の更新が送信されました
2016年1月18日
最終確認日
2016年1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。