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Clinical Trials/NCT02088294
NCT02088294CompletedNot Applicable

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

University of Southern California1 site in 1 country240 target enrollmentStarted: May 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
240
Locations
1
Primary Endpoint
Change in Physical activity

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
14 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Non-intervention control

No Intervention

No intervention will be delivered.

Lifestyle Education (LS)

Experimental

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 .

Intervention: Lifestyle Education (LS) (Behavioral)

LS + Stress Reduction Guided Imagery

Experimental

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.

Intervention: Lifestyle Education (LS) (Behavioral)

LS + Stress Reduction Guided Imagery

Experimental

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.

Intervention: LS + Stress Reduction Guided Imagery (Behavioral)

LS + Activity/Eating Guided Imagery

Experimental

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.

Intervention: Lifestyle Education (LS) (Behavioral)

LS + Activity/Eating Guided Imagery

Experimental

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.

Intervention: LS + Activity/Eating Guided Imagery (Behavioral)

Outcomes

Primary Outcomes

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 Outcomes

  • Change in Dietary intake(3 months)
  • Change in Salivary Cortisol, daily slope(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marc Weigensberg

Associate Professor, Clinical Pediatrics

University of Southern California

Study Sites (1)

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