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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088294
• Other study ID #: NCCAM 1 RO1 AT008330-01
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: July 31, 2018

Study information

• Verified date: October 2018
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: July 31, 2018
• Est. primary completion date: April 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity
• Stress

Intervention

Behavioral:
• Lifestyle Education (LS)
See arm description
• LS + Stress Reduction Guided Imagery
See Arm Description
• LS + Activity/Eating Guided Imagery
See arm description

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Perceived Stress	Measured by Perceived Stress Scale	3 months
Other	Change in Well-Being	Measured by Psychological General Well-Being Index (GWBS) and the Arizona Integrated Outcomes Scale.	3 months
Other	Change in Adiposity	BMI will be determined based on standards for age and sex, using clinical balance and stadiometer. Percent body fat will be determined by bioimpedance.	3 months
Other	Change in Insulin resistance	The Homeostatic Model Insulin Resistance Index will be determined based on measures of fasting glucose and insulin.	3 months
Other	Change in Carotid artery intima media thickness	Determined by carotid artery ultrasound.	15 months
Other	Change in Self-determination Theory Constructs	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.	3 months
Other	Change in Intuitive eating	Intuitive Eating Scale measures attitudes and behaviors relating to intuitive eating.	3 months
Primary	Change in Physical activity	Physical activity and sedentary behavior will be measured by accelerometry and 3-day physical activity recall.	3 months
Secondary	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.	3 months
Secondary	Change in Dietary intake	Dietary intake of macronutrients measured by 3-day diet record	3 months