このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

A Pilot Study Evaluating Go NAP SACC's Web-based Nutrition Tool for Child Care

2017年2月15日 更新者:University of North Carolina, Chapel Hill

Evaluation of Go NAP SACC: A Pilot Study Evaluating the Nutrition Tool of the Web-based Tool Based on the NAP SACC Program

The purpose of this project is to evaluate the effectiveness of Go NAP SACC (Get online with Nutrition and Physical Activity Self-Assessment for Child Care), a suite of web-based tools designed to help child care programs improve their nutrition environment (specifically classrooms serving 3-5 year olds) over the course of 4 months.

調査の概要

状態

完了

介入・治療

詳細な説明

National data show that many children, even as young as 2-5 years old, have adopted unhealthy eating patterns and are overweight/obese. Interventions targeting early childhood are critical for reversing these trends. More than half of 3-6 year olds in the US are enrolled in center-based child care programs, where they spend more than 25 hours per week. For these children, the center's nutrition environment can influence developing preferences and habits and thereby, weight status. The Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) was developed in 2002 to help child care providers improve their food and physical activity environments. Evaluations of NAP SACC have shown it to be efficacious, but the program's reliance on trained technical assistance professionals and in-person delivery limits its potential for large-scale dissemination, especially in low-resourced rural areas. Go NAP SACC was developed to overcome this challenge by providing tailored web-based tools and resources that allow child care providers to complete more of the program on their own. This study will evaluate Go NAP SACC to determine if web-based delivery can broaden dissemination of the program, particularly in low-resourced rural areas.

This project will use a randomized controlled design to evaluate the impact of Go NAP SACC on centers' nutrition environments. A sample of 40 child care centers will be recruited to take part. Participating centers will be randomized (1:1) into one of two arms: immediate access (intervention) or delayed access (control). Measures will be collected at two time points, baseline and post-intervention (4 months later), to assess change in centers' nutrition environment scores.

The sample of 40 licensed centers will be recruited from rural counties in North Carolina. To facilitate recruitment, county-level Smart Start partnerships (local organizations that have existing relationships with child care programs) will be asked to share information about the study with their local centers and compile a list of those who might be interested in participating. Then, trained research assistants will follow-up with interested centers by telephone to confirm interest and eligibility. To be eligible, a center must serve 3-5 year old children and have 2 preschool teachers willing to take part in measures along with the center director, have a quality rating of 2-5 stars (or be exempt from ratings), and not have participated in NAP SACC in the last 6 months. Centers directors will complete a memorandum of understanding and informed consent; and teachers will be given informational fact sheets (but will not be asked to sign consent).

Centers will be randomized following their completion of baseline measures. Those randomized into the intervention arm will be given immediate access to Go NAP SACC online tools. To facilitate their use, technical assistance providers from the local Smart Start partnerships will provide an in-person orientation to each center director to help them register, learn to navigate the website, and review a timeline for implementation. Center directors will then have 4 months to complete the self-assessment, select goals to work on, create action plans, and implement those plans using resources from the tips and materials library. Technical assistance staff will provide brief monthly check-ins (by telephone or email) to prompt continued efforts. Centers randomized into the control group will receive the same access and support just 4-6 months later (once post-intervention measures are complete).

To evaluate the impact of Go NAP SACC, centers' nutrition environments will be assessed at two timepoints: baseline and post-intervention. These assessments will use the self-report version of the Environment and Policy Assessment and Observation (EPAO-SR), which uses self-administered surveys completed by directors and preschool teachers. The EPAO-SR will be modified to focus solely on the nutrition environment (eliminating physical activity and screen time items).

The statistical analysis will compare the differences in mean change in centers' nutrition environment scores from pre- to post-intervention between intervention and control groups. The analysis will assess change in the overall nutrition environment score, as well as changes in each of the seven environmental sub-components. Analyses will involve testing of the hypotheses under the intent-to-treat (ITT) principle using SAS v.9.2 and Generalized Linear Modeling (PROC GLM). Use of PROC GLM, instead of a simple t-test, will allow us to control for key characteristics (e.g., technical assistance staff, quality star rating, participation in Child and Adult Care Food Program). To further explore the effect of the intervention, the investigators will fit Generalized Linear Mixed Models that: 1) adjust for baseline variables distributed differently between the intervention and comparison groups; 2) test interaction terms between the treatment group and other covariates; and 3) examine completers only.

NOTE DEVIATION: While the anticipated sample was 40 child care centers, only 33 enrolled, 31 of which provided sufficient baseline and follow-up data to be included in the analysis.

研究の種類

介入

入学 (実際)

102

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

    • North Carolina
      • Chapel Hill、North Carolina、アメリカ、27599
        • UNC Chapel Hill

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

18年歳以上 (大人、高齢者)

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:

  • Child Care Centers must have a quality rating of 2-5 stars OR be licensed as GS110-106 (faith-based and exempt from rating), serve lunch and a snack, and have 3-4 year old classrooms and 2 preschool teacher willing to participate.
  • Teachers must teach in the 3-4 year old classrooms.
  • Center directors and teachers must be able to read English.

Exclusion Criteria:

  • Child Care Centers cannot have participated in NAP SACC within the last 6 months.

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:他の
  • 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
実験的:Intervention group
Centers in this group will be granted immediate access to the Go NAP SACC website following randomization with minimal support from a local technical assistance provider. The center director will have 4 months to use Go NAPSACC tools.
Go NAP SACC is a suite of online tools designed to help child care programs improve their nutrition environment. Tools include: self-assessment, goal setting, action planning, and tips and materials. In addition to these online tools, local technical assistance providers offer center directors an orientation on how to use Go NAP SACC and minimal ongoing technical assistance.
介入なし:Control group
During the study, centers in this group will receive no intervention. However, they will be granted delayed access to the Go NAP SACC website and technical assistance support after post-intervention measures are collected.

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
Change in EPAO-SR Scores from Baseline to Post-intervention
時間枠:Measures collected at baseline (2-4 weeks prior to the intervention) and post-intervention (1-3 weeks following the intervention)
Nutrition-related environmental characteristics will be assessed using the EPAO-SR, integrating data from the center director, child care teachers, and trained staff (reviewing policy documents).Data from all components is used in scoring. Item responses are used to derive variables assessing compliance with 42 nutrition best practices (BPs). Each nutrition BP variable is scored on a 4-point scale (0-3), where higher scores indicate closer BP compliance. Nutrition BP variables are then sorted into one of 7 environmental components: foods provided (12), beverages provided (5), feeding practices (8), feeding environment (8), menus (1), education & professional development (6), or policy (1). Environmental summary scores are calculated by averaging scores from relevant nutrition BP variables; hence, summary scores range from 0 to 3. An overall nutrition score is calculated by summing the 7 environmental summary scores; hence overall nutrition scores range from 0 to 21.
Measures collected at baseline (2-4 weeks prior to the intervention) and post-intervention (1-3 weeks following the intervention)

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:Dianne S Ward, EdD、University Of North Carolina, Chapel Hill

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。

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

2014年5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

2016年8月26日

QC基準を満たした最初の提出物

2016年8月30日

最初の投稿 (見積もり)

2016年9月5日

学習記録の更新

投稿された最後の更新 (実際)

2017年2月17日

QC基準を満たした最後の更新が送信されました

2017年2月15日

最終確認日

2017年2月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 14-0931

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?

いいえ

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。

環境関連疾患の臨床試験

  • Adelphi Values LLC
    Blueprint Medicines Corporation
    完了
    肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されました
    アメリカ

Go NAP SACCの臨床試験

3
購読する