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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02088294
Enrollment
240
Registered
2014-03-14
Start date
2014-05-31
Completion date
2018-07-31
Last updated
2018-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Obesity, Stress

Keywords

obesity, stress, intuitive eating, guided imagery, adolescents, insulin resistance, latinos, minorities

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.

Interventions

BEHAVIORALLifestyle Education (LS)

See arm description

BEHAVIORALLS + Stress Reduction Guided Imagery

See Arm Description

BEHAVIORALLS + Activity/Eating Guided Imagery

See arm description

Sponsors

University of Southern California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Physical activity3 monthsPhysical activity and sedentary behavior will be measured by accelerometry and 3-day physical activity recall.

Secondary

MeasureTime frameDescription
Change in Salivary Cortisol, daily slope3 monthsSalivary cortisol will be collected on 3 successive days at awakening, 30-minutes post-awakening, and in the evening.
Change in Dietary intake3 monthsDietary intake of macronutrients measured by 3-day diet record

Other

MeasureTime frameDescription
Change in Insulin resistance3 monthsThe Homeostatic Model Insulin Resistance Index will be determined based on measures of fasting glucose and insulin.
Change in Carotid artery intima media thickness15 monthsDetermined by carotid artery ultrasound.
Change in Perceived Stress3 monthsMeasured by Perceived Stress Scale
Change in Intuitive eating3 monthsIntuitive Eating Scale measures attitudes and behaviors relating to intuitive eating.
Change in Self-determination Theory Constructs3 monthsConstructs 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.
Change in Well-Being3 monthsMeasured by Psychological General Well-Being Index (GWBS) and the Arizona Integrated Outcomes Scale.
Change in Adiposity3 monthsBMI will be determined based on standards for age and sex, using clinical balance and stadiometer. Percent body fat will be determined by bioimpedance.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026