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

Primary Purpose

Obesity, Insulin Resistance, Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Education (LS)
LS + Stress Reduction Guided Imagery
LS + Activity/Eating Guided Imagery
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity focused on measuring obesity, stress, intuitive eating, guided imagery, adolescents, insulin resistance, latinos, minorities

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Southern California

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Non-intervention control

Lifestyle Education (LS)

LS + Stress Reduction Guided Imagery

LS + Activity/Eating Guided Imagery

Arm Description

No intervention will be delivered.

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 .

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.

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.

Outcomes

Primary Outcome Measures

Change in Physical activity
Physical activity and sedentary behavior will be measured by accelerometry and 3-day physical activity recall.

Secondary Outcome Measures

Change in Salivary Cortisol, daily slope
Salivary cortisol will be collected on 3 successive days at awakening, 30-minutes post-awakening, and in the evening.
Change in Dietary intake
Dietary intake of macronutrients measured by 3-day diet record

Full Information

First Posted
February 26, 2014
Last Updated
October 12, 2018
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT02088294
Brief Title
Guided Imagery Lifestyle Intervention to Promote Health and Prevent Diabetes in Youth
Official Title
Imagine HEALTH (Healthy Eating Active Living Total Health) Study: Guided Imagery Lifestyle Intervention to Promote Health and Prevent Diabetes in Youth
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
April 27, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance, Stress
Keywords
obesity, stress, intuitive eating, guided imagery, adolescents, insulin resistance, latinos, minorities

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-intervention control
Arm Type
No Intervention
Arm Description
No intervention will be delivered.
Arm Title
Lifestyle Education (LS)
Arm Type
Experimental
Arm Description
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 .
Arm Title
LS + Stress Reduction Guided Imagery
Arm Type
Experimental
Arm Description
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.
Arm Title
LS + Activity/Eating Guided Imagery
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Lifestyle Education (LS)
Intervention Description
See arm description
Intervention Type
Behavioral
Intervention Name(s)
LS + Stress Reduction Guided Imagery
Intervention Description
See Arm Description
Intervention Type
Behavioral
Intervention Name(s)
LS + Activity/Eating Guided Imagery
Intervention Description
See arm description
Primary Outcome Measure Information:
Title
Change in Physical activity
Description
Physical activity and sedentary behavior will be measured by accelerometry and 3-day physical activity recall.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in Salivary Cortisol, daily slope
Description
Salivary cortisol will be collected on 3 successive days at awakening, 30-minutes post-awakening, and in the evening.
Time Frame
3 months
Title
Change in Dietary intake
Description
Dietary intake of macronutrients measured by 3-day diet record
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Change in Perceived Stress
Description
Measured by Perceived Stress Scale
Time Frame
3 months
Title
Change in Well-Being
Description
Measured by Psychological General Well-Being Index (GWBS) and the Arizona Integrated Outcomes Scale.
Time Frame
3 months
Title
Change in Adiposity
Description
BMI will be determined based on standards for age and sex, using clinical balance and stadiometer. Percent body fat will be determined by bioimpedance.
Time Frame
3 months
Title
Change in Insulin resistance
Description
The Homeostatic Model Insulin Resistance Index will be determined based on measures of fasting glucose and insulin.
Time Frame
3 months
Title
Change in Carotid artery intima media thickness
Description
Determined by carotid artery ultrasound.
Time Frame
15 months
Title
Change in Self-determination Theory Constructs
Description
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.
Time Frame
3 months
Title
Change in Intuitive eating
Description
Intuitive Eating Scale measures attitudes and behaviors relating to intuitive eating.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc J Weigensberg, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34225165
Citation
Bell BM, Spruijt-Metz D, Naya CH, Lane CJ, Wen CKF, Davis JN, Weigensberg MJ. The mediating role of emotional eating in the relationship between perceived stress and dietary intake quality in Hispanic/Latino adolescents. Eat Behav. 2021 Aug;42:101537. doi: 10.1016/j.eatbeh.2021.101537. Epub 2021 Jun 30.
Results Reference
derived
PubMed Identifier
34037459
Citation
Weigensberg MJ, Avila Q, Spruijt-Metz D, Davis JN, Wen CKF, Goodman K, Perdomo M, Wade NB, Ding L, Lane CJ. Imagine HEALTH: Randomized Controlled Trial of a Guided Imagery Lifestyle Intervention to Improve Obesity-Related Lifestyle Behaviors in Predominantly Latinx Adolescents. J Altern Complement Med. 2021 Sep;27(9):738-749. doi: 10.1089/acm.2020.0515. Epub 2021 May 25.
Results Reference
derived
PubMed Identifier
30076988
Citation
Weigensberg MJ, Spruijt-Metz D, Wen CKF, Davis JN, Avila Q, Juarez M, Brown-Wade N, Lane CJ. Protocol for the Imagine HEALTH Study: Guided imagery lifestyle intervention to improve obesity-related behaviors and salivary cortisol patterns in predominantly Latino adolescents. Contemp Clin Trials. 2018 Sep;72:103-116. doi: 10.1016/j.cct.2018.07.009. Epub 2018 Aug 2.
Results Reference
derived

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

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