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Addressing Health Literacy and Numeracy to Prevent Childhood Obesity (GreenLight)

2018年8月19日 更新者:Russell Rothman、Vanderbilt University
In 2003, Surgeon General Richard Carmona suggested that low health literacy is "one of the largest contributors to our nation's epidemic of overweight and obesity." Over 26% of preschool children are now overweight or obese, and children who are overweight by age 24 months are five times as likely as non-overweight children to become overweight adolescents. The aim of the study is to assess the efficacy of a low-literacy/numeracy-oriented intervention aimed at teaching pediatric resident physicians to promote healthy family lifestyles and prevent overweight among young children (age 0-2) and their families in under-resourced communities.

調査の概要

詳細な説明

In 2003, Surgeon General Richard Carmona stated that low health literacy was "one of the largest contributors to our nation's epidemic of overweight and obesity." This assertion is supported by recent studies which have found that low health literacy or numeracy is associated with poorer caregiver breastfeeding knowledge, incorrect mixing of infant formula, difficulty understanding food labels and portion sizes, and higher Body Mass Index (BMI) in adults and children. Of particular concern is the impact of the obesity epidemic on our youngest children. Over 26% of preschool children are now overweight (BMI≥85%) or obese (BMI≥95%) (based on 2007 Health and Human Services/Centers for Disease Control Expert Panel definitions). Rates of obesity in preschool children have doubled over the past decade, with the highest increases among low income and minority children-- the same communities most affected by low health literacy.

To date, clinical efforts to prevent or treat childhood obesity have had limited efficacy. Efforts need to start early, because children who are overweight by age two are five times as likely to become overweight adolescents, and subsequently at higher risk for obesity-related complications including early-onset Type-2 Diabetes and cardiovascular disease. No published clinical studies have rigorously addressed obesity prevention prior to age 2 with a specific low-literacy and numeracy focus. Addressing caregiver health literacy in early childhood is an innovative strategy to promote healthy nutrition and activity among these families and prevent unhealthy weight gain across the child's life, which would have great public health significance by preventing both child and adult chronic illness.

The proposed study is a multi-site randomized, controlled trial to assess the efficacy of a low-literacy/numeracy-oriented intervention designed to promote healthy family lifestyles and to prevent early childhood obesity. The intervention will be delivered through pediatric resident physicians in primary care settings in under-resourced communities. Four academic medical centers will be randomized: Vanderbilt University, the University of Miami, the University of North Carolina at Chapel Hill, and New York University. Two centers will receive the intervention, while the other two centers will receive an active control. At each site, a cohort of 250 English- or Spanish-speaking caregiver-child dyads will be enrolled and followed from the child's 2 month well-child visit through the 24-month well-child visit. The intervention will include a low-literacy-oriented toolkit for pediatric residents to use with families and clear health communication training for the pediatric residents. At control sites, pediatric residents will provide "usual care" with respect to lifestyle counseling, but they will also receive an injury-prevention education program to act as an attention control. The primary hypotheses are that the intervention will improve family dietary and physical activity behaviors and that it will reduce the rate of childhood overweight (BMI≥85%) at age 24 months.

研究の種類

介入

入学 (実際)

865

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

    • Tennessee
      • Nashville、Tennessee、アメリカ、37232
        • Vanderbilt University Medical Center

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

1ヶ月~2ヶ月 (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

Specific Inclusion Criteria at the parent-child dyad level will include:

  • Consent from a primary caregiver (i.e., parent or legal guardian)
  • Caregiver's ability to speak English or Spanish
  • Infant presenting for a 2 month well-child visit (child is 6 ≥ 12 weeks old)
  • Caregiver agrees to participate in the study, and agrees to bring their child to all well-child care visits until their 2 year well-child care visit.

Specific Exclusion Criteria at the parent-child dyad level will include:

  • Child born prior to 32 weeks' gestational age or with a birth weight < 1500 grams
  • Child with weight/length < 3rd percentile at 2 months of age
  • Child with a diagnosis of failure to thrive or with weight that has dropped ≥ 2 percentile curves since the previous well child visit
  • Child with known medical problems that may affect their ability to thrive or requires a special diet (e.g. metabolic disease, uncorrected congenital heart disease, renal disease, lung disease)
  • Caregiver with significant mental or neurologic illness likely to impair their ability to participate
  • Caregiver age < 18 years
  • Caregiver with known plans to move out of the immediate area during the study period
  • Caregiver with poor visual acuity (i.e. vision worse than 20/50 with Rosenbaum Pocket Screener as assessed at the time of recruitment)

Specific Inclusion Criteria at the Pediatric Resident level will include:

  • Participation in the medical center's pediatric resident training program
  • Providing regular care (> 3 sessions per month) in the pediatric resident primary care clinic; AND
  • Consent to participate in the study

Specific Exclusion Criteria at the Pediatric Resident level will include:

  • Providing no regular care in the pediatric resident primary care clinic (e.g., transitional-year resident, Medicine/Pediatrics resident); OR
  • Known plans to leave the training program during the ensuing 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:防止
  • 割り当て:ランダム化
  • 介入モデル:単一グループの割り当て
  • 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
アクティブコンパレータ:Active Control Arm
At Active Comparative Sites, Pediatric Residents will be trained to address injury prevention issues using The Injury Prevention Program (TIPP) approach
Pediatric residents will be trained to address injury prevention using the American Academy of Pediatrics (AAP) TIPP materials.
実験的:Health Communication and Obesity Prevention
Pediatric Residents will be training in effective health communication skills and given a toolkit of literacy/numeracy sensitive educational materials to use with families with children age 2 months to18 months during each well child visit
Pediatric residents will be training in effective health communication skills and given a literacy/numeracy sensitive toolkit (GreenLight) to use with parents during all well child visits from 2 months to 18 months.

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
Percent of children overweight or obese (BMI ≥ 85th%) at 2 years of life
時間枠:2 years
2 years

二次結果の測定

結果測定
時間枠
BMI z score
時間枠:2 years
2 years
Change in Weight/Length z-score over time
時間枠:2 years
2 years
Parental report of infant eating and physical activity behaviors
時間枠:assessed at each well child visit
assessed at each well child visit
Parental assessment of physician communication
時間枠:each clinic visit
each clinic visit
Parental self-efficacy
時間枠:2 years
2 years
Physician knowledge and satisfaction
時間枠:2 years
2 years

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。

スポンサー

捜査官

  • 主任研究者:Russell L Rothman, MD MPP、Vanderbilt University
  • 主任研究者:Lee Sanders, MD MPH、Stanford University
  • 主任研究者:Kori Flower, MD MS MPH、UNC Chapel Hill
  • 主任研究者:Shonna Yin, MD MS、NYU
  • 主任研究者:Alan Delamater, LP PhD、University of Miami
  • 主任研究者:Eliana Perrin, MD MPH、Duke University

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

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)

2010年4月28日

一次修了 (実際)

2014年10月1日

研究の完了 (実際)

2014年10月1日

試験登録日

最初に提出

2009年12月28日

QC基準を満たした最初の提出物

2009年12月28日

最初の投稿 (見積もり)

2009年12月30日

学習記録の更新

投稿された最後の更新 (実際)

2018年8月21日

QC基準を満たした最後の更新が送信されました

2018年8月19日

最終確認日

2018年8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

  • 1R01HD059794-01 (米国 NIH グラント/契約)

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。

Injury Prevention Armの臨床試験

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