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Guided Imagery Lifestyle Intervention to Promote Health and Prevent Diabetes in Youth

2018년 10월 12일 업데이트: Marc Weigensberg, University of Southern California

Imagine HEALTH (Healthy Eating Active Living Total Health) Study: Guided Imagery Lifestyle Intervention to Promote Health and Prevent Diabetes in Youth

The childhood obesity epidemic, which falls disproportionately on Latino adolescents, represents a major public health threat to the current generation of youth, and therefore to the health of the nation overall. This project directly addresses the role of psychosocial stress in promoting obesity and metabolic disease risk, and investigates the role of the mind-body CAM intervention of guided imagery in both reducing stress and promoting healthy lifestyle behaviors that could dramatically improve the metabolic health of today's youth.

연구 개요

상세 설명

The childhood obesity epidemic represents a major health threat to the current generation of youth, and falls disproportionately on urban, Latino adolescents. Data suggests modern inner-city minority youth suffer from high levels of psychosocial stress, and that such chronic stress contributes to obesity and insulin resistance, increasing risk of type 2 diabetes, cardiovascular disease, fatty liver disease, and other obesity-related disorders. Guided imagery is a mind-body complementary/alternative medicine (CAM) modality that offers promise as a therapeutic intervention to reduce psychosocial stress, and also to promote healthy lifestyle behaviors. In a pilot 12-week lifestyle intervention, Interactive Guided ImagerySM significantly reduced salivary cortisol, reduced sedentary behavior, and increased moderate physical activity in overweight Latino adolescents. The overall aim of this proposal is to determine the separate contributions of stress reduction guided imagery and health behavior guided imagery, when delivered in the context of a health-promoting, lifestyle intervention, on short-term and long-term stress-reduction and behavioral outcomes in predominantly Latino high school students. The study consists of a high school-based, 12-week lifestyle intervention delivered in an after school program to urban, predominantly Latino adolescents. The intervention features a health-promoting, lifestyle education class, combined with a group guided imagery intervention that is theoretically grounded in Self-Determination Theory (SDT). High school students are randomized to one of 4 intervention arms 1) Non-intervention control; 2) lifestyle education alone (LS); 3) LS + Stress Reduction guided imagery alone; 4) LS + Physical Activity/Healthy Eating guided imagery. Outcomes will be measured upon completion of the 12-wk intervention, after an additional 6-month maintenance program, and after a further 6-month period of no program contact. Primary outcomes will be change in salivary cortisol patterns and changes in physical activity and dietary intake. Secondary outcomes are insulin resistance, body fat, carotid intima media thickness, metabolic syndrome, perceived stress, well-being (self-esteem, health related quality of life), and measures of mediation by SDT constructs. Results will demonstrate the isolated effects of the lifestyle education and the two different forms of guided imagery, and could shift the paradigm of obesity prevention and treatment in urban minority youth to include attention to social stress and promotion of well-being.

연구 유형

중재적

등록 (실제)

240

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

    • California
      • Los Angeles, California, 미국, 90033
        • University of Southern California

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

14년 (어린이)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Male and female enrolled in second year (i.e. sophomore year) of high school at time of consent into study, junior year at time of intervention
  • Self-stated intent to complete high school
  • Predominantly minority ethnicity (self-reported)
  • Overweight/ obese and normal weight
  • Agreement to attend up to 3 after school classes per week for the 12 weeks of the program

Exclusion Criteria:

  • Serious chronic illness or physical, cognitive, or behavioral disability that would prevent ability to fully receive intervention
  • Prior diagnosis of clinical eating disorder, psychiatric disorder, or significant cognitive disability
  • Lack of English fluency
  • Participation in previous "Council" programs offered through the school
  • Participation in formal weight-loss programs in 3 months preceding entry to study
  • Pregnancy
  • Sibling or other household member enrolling for the intervention

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Non-intervention control
No intervention will be delivered.
실험적: Lifestyle Education (LS)
The lifestyle curriculum will be taught in twice weekly after-school sessions of ~1.25 hours, one physical activity and one nutrition-related, delivered over 12-weeks during the course of a single academic semester. The lifestyle program will utilize the "Shape Up" curriculum of SOSMentor, a community non-profit collaborator, modified to seamlessly integrate key concepts of the non-diet philosophy of "Intuitive Eating". The curriculum fully encompasses health-promoting nutrition and physical activity practices consistent with consensus recommendations .
See arm description
실험적: LS + Stress Reduction Guided Imagery
In addition to the after school lifestyle classes, participants will receive group Interactive Guided Imagery (IGI) consisting of standard stress reduction imagery practices, delivered once weekly for 12 weeks as an after school class of ~1.25 hours. The group IGI will be delivered by certified facilitators in the context of the facilitated group process known as "Council", a group communication process used by many indigenous and other cultures.
See arm description
See Arm Description
실험적: LS + Activity/Eating Guided Imagery
In addition to the after school lifestyle classes, participants will receive group Interactive Guided ImagerySM (IGI) delivered once weekly for 12 weeks as an after school class of ~1.25 hours. The group IGI will be delivered by certified facilitators in the context of the facilitated group process known as "Council", a group communication process used by many indigenous and other cultures. Participants in this arm will receive stress reduction IGI for 4 wks, plus 8 weekly sessions with IGI content designed to promote physical activity and healthy eating.
See arm description
See arm description

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Physical activity
기간: 3 months
Physical activity and sedentary behavior will be measured by accelerometry and 3-day physical activity recall.
3 months

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Salivary Cortisol, daily slope
기간: 3 months
Salivary cortisol will be collected on 3 successive days at awakening, 30-minutes post-awakening, and in the evening.
3 months
Change in Dietary intake
기간: 3 months
Dietary intake of macronutrients measured by 3-day diet record
3 months

기타 결과 측정

결과 측정
측정값 설명
기간
Change in Perceived Stress
기간: 3 months
Measured by Perceived Stress Scale
3 months
Change in Well-Being
기간: 3 months
Measured by Psychological General Well-Being Index (GWBS) and the Arizona Integrated Outcomes Scale.
3 months
Change in Adiposity
기간: 3 months
BMI will be determined based on standards for age and sex, using clinical balance and stadiometer. Percent body fat will be determined by bioimpedance.
3 months
Change in Insulin resistance
기간: 3 months
The Homeostatic Model Insulin Resistance Index will be determined based on measures of fasting glucose and insulin.
3 months
Change in Carotid artery intima media thickness
기간: 15 months
Determined by carotid artery ultrasound.
15 months
Change in Self-determination Theory Constructs
기간: 3 months
Constructs of SDT will be assessed as theoretical mediators of intervention effects using the following survey measures: Perceived Competence for Participating in Regular Physical Activity (PCSPA) and for Healthy Eating (PCSHE); Health Care Climate Questionaire to determine autonomy support; Exercise Self-Regulation Questionnaire and Treatment Self-Regulation Questionnaire to determine autonomous motivation for physical activity and healthy eating; Group Cohesion Scale to assess relatedness.
3 months
Change in Intuitive eating
기간: 3 months
Intuitive Eating Scale measures attitudes and behaviors relating to intuitive eating.
3 months

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 (실제)

2014년 5월 1일

기본 완료 (실제)

2018년 4월 27일

연구 완료 (실제)

2018년 7월 31일

연구 등록 날짜

최초 제출

2014년 2월 26일

QC 기준을 충족하는 최초 제출

2014년 3월 12일

처음 게시됨 (추정)

2014년 3월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 10월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 10월 12일

마지막으로 확인됨

2018년 10월 1일

추가 정보

이 연구와 관련된 용어

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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