Guided Imagery Intervention for Obese Latino Adolescents
1 other identifier
interventional
51
1 country
1
Brief Summary
Guided imagery, a mind-body complementary/alternative treatment modality, offers promise to reduce stress and promote lifestyle behavior change to reduce diabetes and heart disease risk in obese Latino adolescents. The overall purpose of this study was to determine whether guided imagery, could reduce diabetes risk in obese Latino adolescents undergoing a lifestyle intervention. The specific objectives were: 1) To pilot test a new 12-week lifestyle intervention in obese Latino adolescents, in order to determine the effects of the mind-body technique of Interactive Guided ImagerySM, over and above those of healthy lifestyle education, on eating and physical activity behaviors, stress and stress biomarkers, and hormonal markers of diabetes risk; and 2) To explore the way that changes in stress produced by the intervention were associated with changes in hormonal markers of diabetes risk, particularly insulin resistance. The investigators hypothesized that participants who received guided imagery program in addition to the healthy lifestyle education would show greater improvements in insulin resistance, physical activity, dietary intake, and stress, than those receiving the healthy lifestyle education without the guided imagery. The investigators further hypothesized that reductions in stress due to the intervention would be associated with improvements in insulin resistance, a major hormonal marker of diabetes risk. For this study, obese, Latino adolescents (age 14-17) were randomized to receive either 12 weekly sessions of the lifestyle education plus guided imagery program, or lifestyle education plus a digital storytelling computer program (as a control). Outcome measures were assessed before and after the 12-week intervention, comparing the differences between the intervention groups behavioral (eating and physical activity behaviors), biological (insulin resistance and stress hormones), and psychological (stress) outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Jan 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 1, 2013
CompletedFirst Posted
Study publicly available on registry
July 10, 2013
CompletedJuly 10, 2013
July 1, 2013
1.9 years
July 1, 2013
July 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insulin sensitivity/resistance
Insulin sensitivity measured by the frequently sampled IV glucose tolerance test; insulin resistance measured by HOMA insulin resistance index
Baseline and 12-weeks (post-intervention)
Secondary Outcomes (2)
Physical activity
Baseline and 12-weeks (post-intervention)
Dietary intake
Baseline and 12-weeks (post-intervention)
Other Outcomes (6)
Perceived stress
Baseline and 12-weeks (post-intervention)
Salivary cortisol: diurnal patterns
Baseline and 12-weeks (post-intervention)
Body composition
Baseline and 12-weeks (post-intervention)
- +3 more other outcomes
Study Arms (2)
Guided Imagery
EXPERIMENTALThe guided imagery program curriculum, added to the lifestyle education curriculum, consists of 12 weekly, 45-minute modules, delivered one-on-one immediately following the lifestyle education class each week. Guided imagery was based on 2 major underlying theoretical principles: 1) relaxation/stress reduction imagery; and 2) imagery designed to improve eating and physical activity behaviors.
Digital storytelling ("Control")
ACTIVE COMPARATORThe digital storytelling program curriculum, to control for contact time with research staff, consists of 12 weekly 45-minute modules delivered one-on-one immediately following the lifestyle education class each week.
Interventions
Eligibility Criteria
You may qualify if:
- Age 14-17, girls and boys; enrolled/attending high school
- Latino ethnicity (self-reported all 4 grandparents of Latino heritage);
- Obese: BMI \> 95th percentile for age and gender
- Live within 10 mile radius of medical center
You may not qualify if:
- Participation in any weight loss program, or weight loss of 5% or more of body weight, within the 6 months preceding entry to study
- Regular participation (present or past) in mind-body stress reduction/ relaxation practices such as meditation, hypnotherapy, yoga, biofeedback, etc.
- Serious chronic illness; or physical, cognitive or behavioral disability that would prevent ability to fully receive intervention.
- Prior diagnosis of medical condition or medication that may effect body composition or insulin sensitivity/secretion (e.g. diabetes, untreated hypothyroidism, prednisone).
- Prior diagnosis of clinical eating disorder or psychiatric disorder.
- Lack of fluency in English.
- Pregnancy
- Habitual or frequent alcohol or illicit drug use
- Participation on interscholastic athletic team during period of intervention.
- Scheduling conflicts preventing attendance for 12 sequential weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Southern California
Los Angeles, California, 90033, United States
Related Publications (1)
Weigensberg MJ, Lane CJ, Avila Q, Konersman K, Ventura E, Adam T, Shoar Z, Goran MI, Spruijt-Metz D. Imagine HEALTH: results from a randomized pilot lifestyle intervention for obese Latino adolescents using Interactive Guided ImagerySM. BMC Complement Altern Med. 2014 Jan 17;14:28. doi: 10.1186/1472-6882-14-28.
PMID: 24433565DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc J Weigensberg, MD
University of Southern California
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 1, 2013
First Posted
July 10, 2013
Study Start
January 1, 2007
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
July 10, 2013
Record last verified: 2013-07