이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Effects of Interrupting Sedentary Behavior on Metabolic and Cognitive Outcomes in Children

Background:

- Some studies in adults have found that insulin and glucose blood levels are lower when a long period of sitting is broken up with walking, compared to sitting without breaks. This means that the body can better process sugars when there are walking breaks during the day. Researchers want to know if this is also true for children. Some studies have found that children s attention and memory might be better after exercise. Researchers want to know if short walking breaks have the same effects.

Objectives:

- To understand if breaking up sitting with walking helps children s bodies better use sugars and improves children s concentration.

Eligibility:

- Healthy children ages 7 to 11.

Design:

  • Participants will be screened with a physical exam, medical history, exercise test, picture vocabulary test, and medical tests including blood tests and X-rays.
  • Participants will return for two 7-hour visits. In the month before the visits, they will wear a physical activity monitor for one week so researchers know how active they are. Once they will take the sitting only test and once the sitting breaks test.
  • During the sitting only test, participants will sit for 3 hours.
  • During the sitting breaks test, they will sit for 3 hours with 3-minute walking breaks every 30 minutes.
  • Both days, they will drink sugar water. Then the participants will have blood drawn from a needle that is kept in place, and they will wear a heart monitor. They will take attention and working memory tests on a computer and answer questions about how they feel. They will eat a meal at the end of the test day.

연구 개요

상세 설명

Prevention of pediatric obesity and its complications are U.S. public health priorities. Promoting physical activity has been proposed as an intervention strategy. Apart from reducing excessive weight, physical activity improves cardiovascular fitness, insulin sensitivity, and academic performance. However, emerging evidence in adults suggests that increased physical activity may not entirely counteract the negative health effects of a sedentary lifestyle.

Sedentary behavior is defined as a set of low-intensity activities involving limited body movement (e.g.: TV viewing, prolonged sitting). TV viewing is associated with lower cognitive functioning and depressive symptoms. Some studies found higher levels of childhood sedentary behavior predicted higher body mass index (BMI) and cholesterol in adulthood, suggesting that negative health consequences may begin early. Dunstan et al. conducted the first lab-based study in adults investigating interrupting prolonged sedentary behavior with physical activity breaks. The authors found that for overweight adults, adding 2-minute moderate-intensity walking breaks every 20 minutes reduced postprandial insulin and glucose responses by 23.0% and 29.6%, respectively. Thus, interrupting sedentary behavior may be an intervention strategy to reduce health risks.

In children, cross-sectional observational studies indicate that sedentary behavior patterns characterized by short bouts of activity are not associated with increased cardiometabolic risk. However to date, no in-lab studies have manipulated sedentary behavior in children. Therefore, we propose to conduct a randomized crossover pilot feasibility study to assess whether interrupting sedentary behavior influences metabolic and executive function, attention, mood, anxiety, and dietary intake. Children, ages 7-11 years, will complete two conditions in random order: 3 hours of prolonged sitting and 3 hours of sitting interrupted with 3 minutes of moderate-intensity walking every 30 minutes. The specific aim of this project is to investigate whether interrupting sedentary behavior improves metabolic parameters and changes executive function, attention, mood, anxiety, and dietary intake. The primary hypothesis is that postprandial insulin incremental area under the curve (iAUC) will be lower in the interrupted sitting vs. the prolonged sitting condition. The exploratory secondary hypotheses are that glucose iAUC, executive function, attention, mood, anxiety, and dietary intake will differ between the two conditions.

This project will investigate if interrupting sedentary time affects potential negative health consequences of sedentary behavior in children. If interrupting sedentary time in short bouts has beneficial effects among children, interventions examining the frequency, duration, and intensity of such interruptions could be developed. Thus, these results have the potential to provide insight into novel behavioral intervention targets in youth.

연구 유형

중재적

등록 (실제)

89

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Maryland
      • Bethesda, Maryland, 미국, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

7년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

  • INCLUSION CRITERIA:

Participants will qualify for the study if they meet the following criteria:

  1. Good general health.
  2. Age greater than or equal to 7 and <11.99 years.
  3. Fasting plasma glucose < 100 mg/dL
  4. a) Phase 1: Body mass index (BMI) between the 5th and 85th percentiles, as determined by the CDC age- and sex- specific growth charts.

    b) Phase 2: BMI above the 85th percentile, as determined by the CDC age- and sex- specific growth charts.

EXCLUSION CRITERIA:

  1. Significant cardiac or pulmonary disease likely to or resulting in hypoxia or decreased perfusion.
  2. Evidence of impaired glucose tolerance or type 2 diabetes, including fasting plasma glucose greater than or equal to 100 mg/dL.
  3. Presence of other endocrinologic disorders leading to obesity (e.g.: Cushing Syndrome).
  4. Participants who have, or whose parent/guardians have, current substance abuse or a psychiatric disorder or other condition that, in the opinion of the investigators, would impede competence, compliance, or prevent the completion of the study.
  5. Participants who have, or are currently receiving, anti-psychotic drugs that would affect metabolism, cognitive outcomes, and body habitus.
  6. Participants receiving medical treatment other than diet for hypertension or dyslipidemia.
  7. Participants with precocious puberty and/or receiving androgen and estrogen therapy.
  8. Participants currently taking medications for ADHD, or any disorder or use of medications known to affect body composition or weight.
  9. Presence of pre-existing neurocognitive disabilities, or an age-adjusted score below 85 on the Picture Vocabulary Test at the screening visit.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Lower insulin incremental area under the curve (iAUC) during 3 hours after the OGTT.
기간: 3 hours
3 hours

2차 결과 측정

결과 측정
기간
Lower postprandial glucose iAUC during 3 hours after the OGTT.
기간: 3 hours
3 hours
Differences in executive functioning and attention scores.
기간: 3 hours
3 hours
Differences in positive and negative affect scores.
기간: 3 hours
3 hours
Differences in anxiety.
기간: 3 hours
3 hours
Differences in post-test dietary intake.
기간: 3 hours
3 hours

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2013년 6월 26일

기본 완료 (실제)

2017년 3월 8일

연구 완료 (실제)

2018년 1월 29일

연구 등록 날짜

최초 제출

2013년 6월 26일

QC 기준을 충족하는 최초 제출

2013년 6월 26일

처음 게시됨 (추정)

2013년 6월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 1월 31일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 1월 30일

마지막으로 확인됨

2018년 1월 29일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 130169
  • 13-CH-0169

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

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미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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