栄養教育ツールとしての食べられるアルファベット
小児の体重管理プログラムにおける栄養教育ツールとしての食べられるアルファベット カードの有効性の測定
This pilot randomized controlled trial will test the effectiveness of Eatable Alphabet cards, a child friendly nutrition education tool, on child weight and related behaviors in a clinical sample of 2 to 10-year-old children with overweight/obesity, referred to a pediatric weight management program.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
The goal of this research study is to determine whether the use of Eatable Alphabet cards in addition to standard weight management in a primary care setting will increase vegetable consumption. Additional outcomes that will be examined include fruit consumption, child engagement in meal selection and preparation, and clinic follow-up. If the intervention shows a significant effect in the above outcome measures, Eatable Alphabet cards can be implemented as a standard component of obesity management in primary care settings. It is hypothesized that the intervention will increase vegetable consumption, increase child engagement in meal selection and preparation, and increase clinic follow-up.
The study design is randomized control trial, in which the control group includes parent-child dyads receiving care as usual in the weight management program, including nutrition education, and the intervention group includes parent-child dyads receiving care as usual in the weight management program plus Eatable Alphabet cards in addition to typical nutrition education. All study participants will be families receiving care at the POWER Kids Weight Management Program at 410 Lakeville Road, with the child between the ages of 2 and 10 who have overweight or obesity. The primary outcome is parent reported frequency of child vegetable consumption. Secondary outcomes include: parent reported frequency of child fruit consumption, parent reported child engagement in meal selection/preparation, follow-up weight management visit attendance, and child anthropometric outcomes.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
-
-
New York
-
New Hyde Park、New York、アメリカ、11040
- Cohen Children's Medical Center
-
-
参加基準
適格基準
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:
- New patient at Cohen Children's Medical Center POWER Kids weight management program (defined as not having been seen by the program within the past 2 years)
- Child between the ages of 2-10
- English-speaking
Exclusion Criteria:
- No appropriate caregiver available for consent.
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：独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
他の：Usual Care
Usual care in the POWER Kids weight management program includes a nutrition assessment and education by a registered dietician nutritionist (RD). This includes taking a detailed dietary history, and providing individualized counseling, motivational interviewing, and nutrition education handouts/ web-based resources. |
Please see above description of usual care. |
|
実験的：Eatable Alphabet
The intervention group will receive usual care, as described above, plus a set of Eatable Alphabet cards, which will be utilized during the visit for counseling and education, and given to the family to take home and use as they wish. |
Eatable Alphabet is a set of kitchen activity cards developed by ChopChop Family, in collaboration with the American Academy of Pediatrics, with funding from the CDC (https://www.chopchopfamily.org/eatable-alphabet/). It includes a series of alphabet cards with family-friendly recipes. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in parent reported child vegetable consumption (servings/day)
時間枠：1 month
|
Parents will complete pre and post intervention/usual care survey measures of vegetable consumption. |
1 month
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in parent reported child fruit consumption (servings/day)
時間枠：1 month
|
Parents will complete pre and post intervention/usual care survey measures of fruit consumption. |
1 month
|
|
Parent reported child engagement in meal selection/preparation
時間枠：1 month
|
Parents will complete pre and post intervention/usual care survey measures of child engagement in meal selection/preparation. |
1 month
|
|
Follow-up weight management visit attendance
時間枠：6 months
|
We will determine whether the patient returned for scheduled follow-up visit via medical record review. |
6 months
|
|
Change in child body mass index (BMI) z-score
時間枠：6 months
|
Weight and height measured by clinical staff at the baseline visit and all subsequent visits over the next six months will be used to calculate body mass index (BMI=kg/m^2). Software will use Centers for Disease Control and Prevention (CDC) reference standards to convert BMI into a BMI z-score based on the child's age and sex. Change in BMI z-score will be defined as BMI z-score 6 months (+/- 3 months) after the intervention visit minus BMI z-score at the baseline intervention visit. |
6 months
|
|
Change in weight for age (WFA) z-score
時間枠：6 months
|
Weight measured by clinical staff at the baseline visit and all subsequent visits over the next six months will be used to generate weight for age (WFA) z-scores using CDC reference standards. Change in WFA z-score will be defined as WFA z-score 6 months (+/- 3 months) after the intervention visit minus WFA z-score at the baseline intervention visit. |
6 months
|
|
Change in percent of the 95th percentile of BMI for age and sex
時間枠：6 months
|
Weight and height measured by clinical staff at the baseline visit and all subsequent visits over the next six months will be used to calculate body mass index (BMI=kg/m^2). Software will use CDC reference standards to convert BMI into a percent of the 95th percentile for the child's age and sex. Change in percent of the 95th percentile will be defined as percent of the 95th percentile 6 months (+/- 3 months) after the intervention visit minus percent of the 95th percentile z-score at the baseline intervention visit. |
6 months
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Michelle W Katzow, MD, MS、Northwell Health and Feinstein Institutes for Medical Research
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- 21-1152
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?
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
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。