Trial record 1 of 4 for:    Completed | guided imagery | United States, California
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Guided Imagery Intervention for Obese Latino Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marc Weigensberg, University of Southern California
ClinicalTrials.gov Identifier:
NCT01895595
First received: July 1, 2013
Last updated: July 3, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Obesity
Insulin Resistance
Metabolic Syndrome
Behavioral: Guided Imagery
Behavioral: Digital Storytelling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Guided Imagery Intervention for Obese Latino Adolescents

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Insulin sensitivity/resistance [ Time Frame: Baseline and 12-weeks (post-intervention) ] [ Designated as safety issue: No ]
    Insulin sensitivity measured by the frequently sampled IV glucose tolerance test; insulin resistance measured by HOMA insulin resistance index


Secondary Outcome Measures:
  • Physical activity [ Time Frame: Baseline and 12-weeks (post-intervention) ] [ Designated as safety issue: No ]
    Physical activity and sedentary behavior measured by 3-day physical activity record

  • Dietary intake [ Time Frame: Baseline and 12-weeks (post-intervention) ] [ Designated as safety issue: No ]
    Dietary intake of macronutrients measured by 3-day diet record


Other Outcome Measures:
  • Perceived stress [ Time Frame: Baseline and 12-weeks (post-intervention) ] [ Designated as safety issue: No ]
    Measured by Perceived Stress Scale

  • Salivary cortisol: diurnal patterns [ Time Frame: Baseline and 12-weeks (post-intervention) ] [ Designated as safety issue: No ]
    Measured by enzyme linked immunoassay to determine diurnal cortisol patterns

  • Body composition [ Time Frame: Baseline and 12-weeks (post-intervention) ] [ Designated as safety issue: No ]
    Measured by air displacement plethysmography and assessment of BMI

  • Self-esteem [ Time Frame: Baseline and 12-weeks (post-intervention) ] [ Designated as safety issue: No ]
  • Intuitive Eating [ Time Frame: Baseline and 12-weeks (post-intervention) ] [ Designated as safety issue: No ]
    Hawks' Intuitive Eating Likert Scale Survey (2005)

  • Salivary cortisol: acute change [ Time Frame: Baseline and 45-minute post-intervention session ] [ Designated as safety issue: No ]
    Acute change in salivary cortisol following 45-minute guided imagery or digital story session during each of the first 3 weeks of the 12-week intervention


Enrollment: 51
Study Start Date: January 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Guided Imagery
The 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.
Behavioral: Guided Imagery
Active Comparator: Digital storytelling ("Control")
The 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.
Behavioral: Digital Storytelling

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. Age 14-17, girls and boys; enrolled/attending high school
  2. Latino ethnicity (self-reported all 4 grandparents of Latino heritage);
  3. Obese: BMI > 95th percentile for age and gender
  4. Live within 10 mile radius of medical center

Exclusion Criteria

  1. Participation in any weight loss program, or weight loss of 5% or more of body weight, within the 6 months preceding entry to study
  2. Regular participation (present or past) in mind-body stress reduction/ relaxation practices such as meditation, hypnotherapy, yoga, biofeedback, etc.
  3. Serious chronic illness; or physical, cognitive or behavioral disability that would prevent ability to fully receive intervention.
  4. Prior diagnosis of medical condition or medication that may effect body composition or insulin sensitivity/secretion (e.g. diabetes, untreated hypothyroidism, prednisone).
  5. Prior diagnosis of clinical eating disorder or psychiatric disorder.
  6. Lack of fluency in English.
  7. Pregnancy
  8. Habitual or frequent alcohol or illicit drug use
  9. Participation on interscholastic athletic team during period of intervention.
  10. Scheduling conflicts preventing attendance for 12 sequential weeks.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01895595

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Marc J Weigensberg, MD University of Southern California
  More Information

No publications provided by University of Southern California

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marc Weigensberg, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT01895595     History of Changes
Other Study ID Numbers: NCCAM 5 R21 AT002556
Study First Received: July 1, 2013
Last Updated: July 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
obesity
stress
intuitive eating
guided imagery
latinos
adolescents
insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Metabolic Syndrome X
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014