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

12. Oktober 2018 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

240

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • California
      • Los Angeles, California, Vereinigte Staaten, 90033
        • University of Southern California

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

14 Jahre bis 17 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Non-intervention control
No intervention will be delivered.
Experimental: 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
Experimental: 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
Experimental: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Physical activity
Zeitfenster: 3 months
Physical activity and sedentary behavior will be measured by accelerometry and 3-day physical activity recall.
3 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Salivary Cortisol, daily slope
Zeitfenster: 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
Zeitfenster: 3 months
Dietary intake of macronutrients measured by 3-day diet record
3 months

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Perceived Stress
Zeitfenster: 3 months
Measured by Perceived Stress Scale
3 months
Change in Well-Being
Zeitfenster: 3 months
Measured by Psychological General Well-Being Index (GWBS) and the Arizona Integrated Outcomes Scale.
3 months
Change in Adiposity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 15 months
Determined by carotid artery ultrasound.
15 months
Change in Self-determination Theory Constructs
Zeitfenster: 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
Zeitfenster: 3 months
Intuitive Eating Scale measures attitudes and behaviors relating to intuitive eating.
3 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

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Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Mai 2014

Primärer Abschluss (Tatsächlich)

27. April 2018

Studienabschluss (Tatsächlich)

31. Juli 2018

Studienanmeldedaten

Zuerst eingereicht

26. Februar 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. März 2014

Zuerst gepostet (Schätzen)

14. März 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. Oktober 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Oktober 2018

Zuletzt verifiziert

1. Oktober 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

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