Clinical trial NCT02088294: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Stress
Keywords: obesity
stress
intuitive eating
guided imagery
adolescents
insulin resistance
latinos
minorities
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 240
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in Physical activity
timeFrame: 3 months
Secondary outcomes:
measure: Change in Salivary Cortisol, daily slope
timeFrame: 3 months
measure: Change in Dietary intake
timeFrame: 3 months
Other outcomes:
measure: Change in Perceived Stress
timeFrame: 3 months
measure: Change in Well-Being
timeFrame: 3 months
measure: Change in Adiposity
timeFrame: 3 months
measure: Change in Insulin resistance
timeFrame: 3 months
measure: Change in Carotid artery intima media thickness
timeFrame: 15 months
measure: Change in Self-determination Theory Constructs
timeFrame: 3 months
measure: Change in Intuitive eating
timeFrame: 3 months
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Marc J Weigensberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.