NCT02088294

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

4 years

First QC Date

February 26, 2014

Last Update Submit

October 12, 2018

Conditions

Keywords

obesitystressintuitive eatingguided imageryadolescentsinsulin resistancelatinosminorities

Outcome Measures

Primary Outcomes (1)

  • Change in Physical activity

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

    3 months

Secondary Outcomes (2)

  • Change in Salivary Cortisol, daily slope

    3 months

  • Change in Dietary intake

    3 months

Other Outcomes (7)

  • Change in Perceived Stress

    3 months

  • Change in Well-Being

    3 months

  • Change in Adiposity

    3 months

  • +4 more other outcomes

Study Arms (4)

Non-intervention control

NO INTERVENTION

No intervention will be delivered.

Lifestyle Education (LS)

EXPERIMENTAL

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 .

Behavioral: Lifestyle Education (LS)

LS + Stress Reduction Guided Imagery

EXPERIMENTAL

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.

Behavioral: Lifestyle Education (LS)Behavioral: LS + Stress Reduction Guided Imagery

LS + Activity/Eating Guided Imagery

EXPERIMENTAL

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.

Behavioral: Lifestyle Education (LS)Behavioral: LS + Activity/Eating Guided Imagery

Interventions

See arm description

LS + Activity/Eating Guided ImageryLS + Stress Reduction Guided ImageryLifestyle Education (LS)

See Arm Description

LS + Stress Reduction Guided Imagery

See arm description

LS + Activity/Eating Guided Imagery

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (5)

  • Toledo-Corral CM, Ding L, Morales JC, Chapman TM, Romero MB, Weigensberg MJ. Morning Serum Cortisol Is Uniquely Associated with Cardiometabolic Risk Independent of Body Composition in Latino Adolescents. Metab Syndr Relat Disord. 2023 May;21(4):214-221. doi: 10.1089/met.2022.0091. Epub 2023 Apr 11.

  • Sumner JA, Gao X, Gambazza S, Dye CK, Colich NL, Baccarelli AA, Uddin M, McLaughlin KA. Stressful life events and accelerated biological aging over time in youths. Psychoneuroendocrinology. 2023 May;151:106058. doi: 10.1016/j.psyneuen.2023.106058. Epub 2023 Feb 17.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

ObesityInsulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Marc J Weigensberg, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Clinical Pediatrics

Study Record Dates

First Submitted

February 26, 2014

First Posted

March 14, 2014

Study Start

May 1, 2014

Primary Completion

April 27, 2018

Study Completion

July 31, 2018

Last Updated

October 17, 2018

Record last verified: 2018-10

Locations