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Lifestyle Modification for Type 2 Diabetes Prevention in Overweight Youth

2012年5月31日 更新者:University of Pennsylvania

The number of youth with Type 2 diabetes (T2D) is rising in the population, which is a concerning public health trend. There has been little research testing ways to prevent the development of this disease in children who are at increased risk to develop T2D. This study tests a family treatment program that treats 4-8 year old children who are at risk for T2D because they are overweight and have a family history of the disease. Sixty at risk children and their parents were assigned to one of 2 treatment conditions. Half of the families (randomly determined) received an intensive family treatment program that trains parents in how to increase healthier foods choices and physical activity for themselves and their children using "behavior modification" strategies. Children receiving this treatment were allowed to taste new fruits and vegetables used a pedometer to record how far they walked every day, and were given a "tool box" of toys and interactive games which promoted physical activity. The other half of the families only received instruction about healthier choices, but received no behavioral modification strategies or physical activity promotion tools. Improvements in children's body weight, blood measures, and behavior patterns were measured after treatment ended (6 months) and then again after 12 months. The results may lead to a better understanding of how family members can positively influence young children's behaviors to help prevent T2D. The objective of proposed study was to test a family-based intervention designed to reduce excess body weight, improve metabolic and cardiovascular profile, and improve diet and physical activity levels in 4 - 8 year old youth who are "at risk" for T2D. This intervention was tested in a 2-arm randomized controlled clinical trial.

Primary Hypotheses:

  1. Compared to children receiving NPA, children receiving LMDP will show greater reductions in excess body weight, greater improvements in metabolic and cardiovascular measures, improved diet, increased physical activity, and reduced television viewing.
  2. Greater reductions in child excess body weight will be associated with greater improvements in metabolic and cardiovascular measures.

Secondary Hypotheses:

  1. Compared to parents receiving the NPA intervention, parents receiving the LMDP intervention will show greater reductions in BMI.
  2. Greater improvements in parent BMI will be associated with greater improvements in child body composition, metabolic and cardiovascular measures, and behavioral outcomes.
  3. Compared to families receiving the NPA intervention, families receiving the LMDP intervention will show an increase in the number of fruits and vegetables and lower energy density foods stored at home.

調査の概要

詳細な説明

There is mounting concern about the development of Type 2 diabetes (T2D) in youth, especially in light of rising childhood obesity rates at younger ages. The health costs of T2D are notable both for the individual and society, and so interventions that can help prevent the development of T2D in early life are needed. Fortunately, there is promising evidence from the Diabetes Prevention Program (DPP) and other randomized trials with adults that the onset of T2D can be prevented through sustainable lifestyle changes. However, intervention programs have not been tested in young children who are "at risk" for developing the disease, even though this may be a critical period for obesity onset and for the formation of early eating and physical activity habits.

The primary aim of the proposed study was to test a family-based intervention that targets improvements in excess weight gain, metabolic and cardiovascular profile, and diet and physical activity in 4 - 8 year old children who are "at risk" for T2D. Specifically, 60 families were randomized either to one of two treatments: Lifestyle Modification for Diabetes Prevention (LMDP, N= 30) or Nutrition and Physical Activity Information (NPA, N= 30). The LMDP intervention trained families in behavioral strategies to increase parent and child intake of fruits, vegetables, and high fiber foods, to limit intake of energy-dense foods, and to increase daily physical activity. A physical activity "tool kit" for the home environment was provided to families. Supporting information about T2D and obesity, as well as nutrition and physical activity, also were provided. Besides the participating parent-child pair, other adult family members with T2D (eg, grandparents, aunts, uncles) were encouraged to participate. The LMDP activities were intended to reduce children's excess body weight and improve their metabolic and cardiovascular measures, to help prevent the onset of insulin resistance. The NPA intervention only received basic information on T2D and obesity, and nutrition and physical activity recommendations. Changes in child body composition, metabolic and cardiovascular measures, and behavioral outcomes were evaluated at 6 months (ie, end-of-treatment) and 12 months (ie, follow up). Changes in parent weight status and the home food environment were secondary outcomes and were assessed as potential mediators of child outcomes.

研究の種類

介入

入学 (実際)

52

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

    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19104
        • University of Pennsylvania Center for Weight and Eating Disorders/Perelman School of Medicine

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

4年~8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 4-8 years old
  • Age- and sex-specific BMI ≥95th percentile

Exclusion Criteria:

  • Children with serious medical conditions
  • Children who show signs of elevated psychopathology, as assessed by the Child Behavior Checklist (CBCL)
  • Children of parents with significantly elevated psychiatric disorders

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: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:Lifestyle Modification for Diabetes Prevention
Family based intervention utilizing Traffic Light Diet, self monitoring, parent behavioral skill training and tool kit of items promoting physical activity.
Family based behavioral intervention utilizing Traffic Light Diet, self monitoring, goal setting, reinforcement and a tool kit containing physical activity-promoting items
他の:Nutrition and Physical Activity
Family based intervention providing education on healthy eating and physical activity but no behavioral skills training, goal setting, self monitoring or physical activity toolkit.
This family based education program provided information on physical activity and healthy eating for parents and children.

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
Body Mass Index (BMI)
時間枠:Baseline, 6 and 12 months
Change in BMI will be measured from baseline to end of intervention (6 months) and and also from 6 months to 12 months.
Baseline, 6 and 12 months
BMI-z score
時間枠:Baseline, 6 and 12 months
Change in BMI-z score will be measured from baseline to end of treatment (6 months) and from 6 months to 12 months.
Baseline, 6 and 12 months
Percent overweight (% overweight)
時間枠:Baseline, 6 and 12 months
Change in percent overweight will be measured from baseline to end of treatment (6 months) and from 6 months to 12 months. Percent overweight is computed as a child's actual BMI minus the median BMI for a child of comparable sex and age, divided by 100.
Baseline, 6 and 12 months
Waist Circumference(cm)
時間枠:Baseline, 6 and 12 months
Change in waist circumference (cm) will be measured from baseline to end of treatment (6 months) and from end of treatment to 12 months.
Baseline, 6 and 12 months
Systolic Blood Pressure
時間枠:Baseline, 6 and 12 months
Change in systolic blood pressure (mm Hg) will be measured from baseline to end of treatment (6 months) and from end of treatment to 12 months.
Baseline, 6 and 12 months
Diastolic Blood Pressure (mm Hg)
時間枠:Baseline, 6 and 12 months
Change in diastolic blood pressure (mm Hg) will be measured from baseline to end of treatment (6 months) and from end of treatment to 12 months.
Baseline, 6 and 12 months
Pulse
時間枠:Baseline, 6 and 12 months
Change in resting pulse will be measured from baseline to end of treatment (6 months) and from end of treatment to 12 months.
Baseline, 6 and 12 months
Physical Activity
時間枠:Baseline, 6 and 12 months
Change in physical activity was measured from baseline to end of treatment (6 months) and from end of treatment to 12 months using an accelerometer. The accelerometer measured light, moderate and moderate-to-vigorous actity over 7 days.
Baseline, 6 and 12 months
Glucose
時間枠:Baseline, 6 and 12 months
Change in blood glucose levels were measured at baseline, 6 and 12 months.
Baseline, 6 and 12 months
Insulin
時間枠:Baseline, 6 and 12 months
Change in plasma insulin levels from baseline to end of treatment (6 months) and from 6 months to 12 months.
Baseline, 6 and 12 months
Change in HDL, LDL, Total Cholesterol and Triglycerides
時間枠:Baseline, 6 and 12 months
Change in lipid profile measures from baseline to end of treatment (6 months) and from 6 months to 12 months.
Baseline, 6 and 12 months
Change in Dietary Intake
時間枠:Baseline, 6 and 12 months
Change in energy (kcals/day), protein, carbohydrate, fat, cholesterol, saturated fat and fiber intake.
Baseline, 6 and 12 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Parent BMI
時間枠:Baseline, 6 and 12 months
Change in parent BMI from baseline to end of treatment (6 months) and from 6 motnths to 12 months.
Baseline, 6 and 12 months

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:Myles S Faith, Ph.D.、University of Pennsylvania

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

2008年8月1日

一次修了 (実際)

2011年1月1日

研究の完了 (実際)

2011年1月1日

試験登録日

最初に提出

2012年5月30日

QC基準を満たした最初の提出物

2012年5月31日

最初の投稿 (見積もり)

2012年6月1日

学習記録の更新

投稿された最後の更新 (見積もり)

2012年6月1日

QC基準を満たした最後の更新が送信されました

2012年5月31日

最終確認日

2012年5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

  • 807106

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。

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