ObesityNCT02088294
Guided Imagery Lifestyle Intervention to Promote Health and Prevent Diabetes in Youth
A study testing Lifestyle Education (LS), LS + Stress Reduction Guided Imagery and LS + Activity/Eating Guided Imagery in people with Obesity and Insulin Resistance, run by University of Southern California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance, Stress
- What is being tested?
- Lifestyle Education (LS), LS + Stress Reduction Guided Imagery and LS + Activity/Eating Guided Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
Official title: Imagine HEALTH (Healthy Eating Active Living Total Health) Study: Guided Imagery Lifestyle Intervention to Promote Health and Prevent Diabetes in Youth
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.
Read the 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.
- Conditions
- Obesity, Insulin Resistance, Stress
- Being tested
- Lifestyle Education (LS), LS + Stress Reduction Guided Imagery, LS + Activity/Eating Guided Imagery
- Keywords
- obesity, stress, intuitive eating, guided imagery, adolescents, insulin resistance, latinos, minorities
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Education (LS)Behavioural
See arm description
LS + Stress Reduction Guided ImageryBehavioural
See Arm Description
LS + Activity/Eating Guided ImageryBehavioural
See arm description
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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. Receives: 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. Receives: Behavioral: Lifestyle Education (LS); Behavioral: LS + Activity/Eating Guided Imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical activity
Physical activity and sedentary behavior will be measured by accelerometry and 3-day physical activity recall.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 3 months
Change in Dietary intake
Dietary intake of macronutrients measured by 3-day diet record
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startMay 2014
- Primary completion27 Apr 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Weigensberg, University of Southern California
- Investigators
- Marc J Weigensberg, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088294
- Sponsor's protocol ID
- NCCAM 1 RO1 AT008330-01
- Status last verified
- Oct 2018
- First submitted
- 26 Feb 2014
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37042653Sumner 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.
PubMed 36827906Bell 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.
PubMed 34225165Weigensberg 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.
PubMed 34037459Weigensberg 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.
PubMed 30076988
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imagine HEALTH (Healthy Eating Active Living Total Health) Study: Guided Imagery Lifestyle Intervention to Promote Health and Prevent Diabetes in Youth
- ClinicalTrials.gov ID
- NCT02088294
- Acronym / sponsor ID
- NCCAM 1 RO1 AT008330-01
- Conditions
- Obesity, Insulin Resistance, Stress
- Keywords
- obesity, stress, intuitive eating, guided imagery, adolescents, insulin resistance, latinos, minorities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-intervention control | No intervention | –No intervention will be delivered. |
| Lifestyle Education (LS) | Experimental | Behavioral: Lifestyle Education (LS)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 . |
| LS + Stress Reduction Guided Imagery | Experimental | Behavioral: Lifestyle Education (LS), Behavioral: LS + Stress Reduction Guided ImageryIn 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. |
| LS + Activity/Eating Guided Imagery | Experimental | Behavioral: Lifestyle Education (LS), Behavioral: LS + Activity/Eating Guided ImageryIn 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. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle Education (LS)See arm description | Behavioural | LS + Activity/Eating Guided Imagery, LS + Stress Reduction Guided Imagery, Lifestyle Education (LS) |
| LS + Stress Reduction Guided ImagerySee Arm Description | Behavioural | LS + Stress Reduction Guided Imagery |
| LS + Activity/Eating Guided ImagerySee arm description | Behavioural | LS + Activity/Eating Guided Imagery |
Primary outcome
Change in Physical activity
Time frame: 3 months
Physical activity and sedentary behavior will be measured by accelerometry and 3-day physical activity recall.
2 secondary outcomes
Change in Salivary Cortisol, daily slope
Time frame: 3 months
Change in Dietary intake
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Derived from this study: PubMed 37042653Toledo-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.
- Derived from this study: PubMed 36827906Sumner 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.
- Derived from this study: PubMed 34225165Bell 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.
- Derived from this study: PubMed 34037459Weigensberg 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.
- Derived from this study: PubMed 30076988Weigensberg 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.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc J Weigensberg, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Education (LS), LS + Stress Reduction Guided Imagery and LS + Activity/Eating Guided Imagery in people with Obesity and Insulin Resistance, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical activity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02088294, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.