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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088294
Recruitment Status : Completed
First Posted : March 14, 2014
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Marc Weigensberg, University of Southern California

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Insulin Resistance Stress Behavioral: Lifestyle Education (LS) Behavioral: LS + Stress Reduction Guided Imagery Behavioral: LS + Activity/Eating Guided Imagery Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Imagine HEALTH (Healthy Eating Active Living Total Health) Study: Guided Imagery Lifestyle Intervention to Promote Health and Prevent Diabetes in Youth
Actual Study Start Date : May 2014
Actual Primary Completion Date : April 27, 2018
Actual Study Completion Date : July 31, 2018

Arm Intervention/treatment
No Intervention: 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 .
Behavioral: Lifestyle Education (LS)
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.
Behavioral: Lifestyle Education (LS)
See arm description

Behavioral: LS + Stress Reduction Guided Imagery
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.
Behavioral: Lifestyle Education (LS)
See arm description

Behavioral: LS + Activity/Eating Guided Imagery
See arm description




Primary Outcome Measures :
  1. Change in Physical activity [ Time Frame: 3 months ]
    Physical activity and sedentary behavior will be measured by accelerometry and 3-day physical activity recall.


Secondary Outcome Measures :
  1. Change in Salivary Cortisol, daily slope [ Time Frame: 3 months ]
    Salivary cortisol will be collected on 3 successive days at awakening, 30-minutes post-awakening, and in the evening.

  2. Change in Dietary intake [ Time Frame: 3 months ]
    Dietary intake of macronutrients measured by 3-day diet record


Other Outcome Measures:
  1. Change in Perceived Stress [ Time Frame: 3 months ]
    Measured by Perceived Stress Scale

  2. Change in Well-Being [ Time Frame: 3 months ]
    Measured by Psychological General Well-Being Index (GWBS) and the Arizona Integrated Outcomes Scale.

  3. Change in Adiposity [ Time Frame: 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.

  4. Change in Insulin resistance [ Time Frame: 3 months ]
    The Homeostatic Model Insulin Resistance Index will be determined based on measures of fasting glucose and insulin.

  5. Change in Carotid artery intima media thickness [ Time Frame: 15 months ]
    Determined by carotid artery ultrasound.

  6. Change in Self-determination Theory Constructs [ Time Frame: 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.

  7. Change in Intuitive eating [ Time Frame: 3 months ]
    Intuitive Eating Scale measures attitudes and behaviors relating to intuitive eating.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088294


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: Marc J Weigensberg, MD University of Southern California
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marc Weigensberg, Associate Professor, Clinical Pediatrics, University of Southern California
ClinicalTrials.gov Identifier: NCT02088294    
Other Study ID Numbers: NCCAM 1 RO1 AT008330-01
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Keywords provided by Marc Weigensberg, University of Southern California:
obesity
stress
intuitive eating
guided imagery
adolescents
insulin resistance
latinos
minorities
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases