ObesityNCT01895595
Guided Imagery Intervention for Obese Latino Adolescents
A study testing Guided Imagery and Digital Storytelling in people with Obesity and Insulin Resistance, run by University of Southern California at 1 site in United States.
Trial summary
Guided imagery, a mind-body complementary/alternative treatment modality, offers promise to reduce stress and promote lifestyle behavior change to reduce diabetes and heart disease risk in obese Latino adolescents. 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, Metabolic Syndrome
- What is being tested?
- Guided Imagery and Digital Storytelling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2008
- 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
- Age 14-17, girls and boys; enrolled/attending high school
- Latino ethnicity (self-reported all 4 grandparents of Latino heritage);
- Obese: BMI > 95th percentile for age and gender
- Live within 10 mile radius of medical center
Who cannot join
- Participation in any weight loss program, or weight loss of 5% or more of body weight, within the 6 months preceding entry to study
- Regular participation (present or past) in mind-body stress reduction/ relaxation practices such as meditation, hypnotherapy, yoga, biofeedback, etc.
- Serious chronic illness; or physical, cognitive or behavioral disability that would prevent ability to fully receive intervention.
- Prior diagnosis of medical condition or medication that may effect body composition or insulin sensitivity/secretion (e.g. diabetes, untreated hypothyroidism, prednisone).
- Prior diagnosis of clinical eating disorder or psychiatric disorder.
- Lack of fluency in English.
Show all 10Show fewer
- Pregnancy
- Habitual or frequent alcohol or illicit drug use
- Participation on interscholastic athletic team during period of intervention.
- Scheduling conflicts preventing attendance for 12 sequential weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
Guided imagery, a mind-body complementary/alternative treatment modality, offers promise to reduce stress and promote lifestyle behavior change to reduce diabetes and heart disease risk in obese Latino adolescents. The overall purpose of this study was to determine whether guided imagery, could reduce diabetes risk in obese Latino adolescents undergoing a lifestyle intervention. The specific objectives were: 1) To pilot test a new 12-week lifestyle intervention in obese Latino adolescents, in order to determine the effects of the mind-body technique of Interactive Guided ImagerySM, over and above those of healthy lifestyle education, on eating and physical activity behaviors, stress and stress biomarkers, and hormonal markers of diabetes risk; and 2) To explore the way that changes in stress produced by the intervention were associated with changes in hormonal markers of diabetes risk, particularly insulin resistance. The investigators hypothesized that participants who received guided imagery program in addition to the healthy lifestyle education would show greater improvements in insulin resistance, physical activity, dietary intake, and stress, than those receiving the healthy lifestyle education without the guided imagery. The investigators further hypothesized that reductions in stress due to the intervention would be associated with improvements in insulin resistance, a major hormonal marker of diabetes risk. For this study, obese, Latino adolescents (age 14-17) were randomized to receive either 12 weekly sessions of the lifestyle education plus guided imagery program, or lifestyle education plus a digital storytelling computer program (as a control). Outcome measures were assessed before and after the 12-week intervention, comparing the differences between the intervention groups behavioral (eating and physical activity behaviors), biological (insulin resistance and stress hormones), and psychological (stress) outcomes.
Read the detailed description
The current proposal pilot tests the investigators' guided imagery intervention in a limited sample of subjects in order to refine the intervention (Study 1) and then proceeds to test the intervention in a controlled, randomized trial (Study 2).
Study 1: Pilot test and refinement of guided imagery program
Specific Aim 1: To pilot, evaluate, and complete development of a guided imagery intervention program based on stress reduction and improving lifestyle behaviors for use with overweight Latino adolescents.
Outcome Objectives: Findings from Study 1 will permit us to test the intervention via a controlled, randomized trial in Study 2.
Study Design The guided imagery intervention program will be combined with a lifestyle education program and will be piloted, one module weekly for 12 weeks, in 8 overweight Latino adolescents (4 males, 4 females). Upon completion of the pilot intervention, participants will participate in an idea-building session about their experiences with the program, in order to develop ideas to add to or modify the program. Participants will discuss the acceptability, cultural relevance, developmental appropriateness and obstacles to efficacy and delivery of the program. The information from these sessions will be analyzed in order to improve the intervention's developmental and cultural relevance and appeal. Analyses of the idea-building data will be similar to analyses used for focus group data, including recording, transcription, and examination of the data for emergent themes. Based on information obtained during the pilot study and from the idea-building sessions, the program will be modified for the intervention study, Study 2.
Study 2: Clinical trial of guided imagery program intervention Specific Aim 2 : To conduct a randomized and controlled trial to test the direct and mediated effects of adding a guided imagery intervention program to a lifestyle education program. Major outcomes will include insulin sensitivity, psychosocial measures, and dietary and physical activity behaviors.
Hypotheses
- The addition of a guided imagery intervention program to a lifestyle education program will be more effective than the lifestyle education program alone in increasing insulin sensitivity (independent of body fat), improving body composition, reducing stress hormone (cortisol) secretion, and decreasing cardiovascular risk factors.
- The addition of a guided imagery intervention program will be more effective than the lifestyle education alone in improving health-promoting dietary and physical activity behaviors.
- The guided imagery intervention program will change behavior and physiology through lowering stress and through changing the meanings of dietary and physical activity behaviors.
Study Design This study is a 12-week randomized, controlled clinical trial. After collection of baseline psychosocial, behavioral, and metabolic outcome measurements, participants will be randomly assigned to either "Treatment Group" with guided imagery program + lifestyle education (n = 20), or "Control Group" with the same lifestyle education + digital storytelling program to ensure equal contact time (n = 20). At the end of the 12-week treatment period, all baseline measures will be repeated, and differences in outcome variables between groups will be assessed.
Inclusion Criteria: see below
Exclusion Criteria: see below
Participant Recruitment: Clinic-based recruitment, past lists of potential recruits from our prior studies, referrals from hospital, local health fairs, and extensive word of mouth.
12-Week Intervention Participants will be randomized to treatment group (lifestyle program plus guided imagery, n=20) or control group (lifestyle program alone, n=20), stratified by sex in order to ensure equal numbers of girls and boys in each study group.
Control and Treatment (guided imagery) interventions will be delivered in weekly, 1.5 hour sessions over a 12-week period in the late afternoon after school. Each session will begin with a 45-minute lifestyle education component delivered in groups of 4-8 subjects, followed immediately by an individual 45 minute guided imagery module for each subject in the Treatment Group, or an individual 45 minute Digital Storytelling module for each subject in the Control Group, in order to ensure equal contact time.
The lifestyle education program curriculum consists of 12 weekly modules focused on decreased intake of added sugars and increased intake of whole grains and fiber in the diet, combined with the non-dieting philosophy of intuitive eating. Educational content relating to principals of healthy nutrition and physically active lifestyle contained within the proposed lifestyle education curriculum are fully consistent with expert committee recommendations for obesity intervention in adolescents.
The guided imagery program curriculum consists of 12 weekly, one-on-one imagery modules based on 2 major underlying theoretical principles: 1) relaxation/stress reduction imagery; and 2) imagery designed to improve eating and physical activity behaviors. The protocol of each one-on-one imagery module will follow the standard procedures of Interactive Guided ImagerySM, consisting of 3 essential aspects: 1) foresight (identification of the issue to be addressed in imagery); 2) insight (the facilitated imagery experience itself); 3) hindsight (discussion and integration of the imagery experience).
The digital storytelling program curriculum, to control for contact time with research staff, consists of 12 weekly 45-minute modules delivered one-on-one immediately following the lifestyle education class each week. Subjects will learn to create and edit their own short films by writing a script, gathering media (images and music), and editing the complete product. The subjects will be free to choose their own topic for their project, excluding topics relating to obesity or health behaviors.
- Conditions
- Obesity, Insulin Resistance, Metabolic Syndrome
- Being tested
- Guided Imagery, Digital Storytelling
- Keywords
- obesity, stress, intuitive eating, guided imagery, latinos, adolescents, insulin resistance
- Medical subject headings
- Obesity, Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided ImageryBehavioural
Digital StorytellingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Guided Imagery | Experimental | The guided imagery program curriculum, added to the lifestyle education curriculum, consists of 12 weekly, 45-minute modules, delivered one-on-one immediately following the lifestyle education class each week. Guided imagery was based on 2 major underlying theoretical principles: 1) relaxation/stress reduction imagery; and 2) imagery designed to improve eating and physical activity behaviors. Receives: Behavioral: Guided Imagery |
| Digital storytelling ("Control") | Active comparator | The digital storytelling program curriculum, to control for contact time with research staff, consists of 12 weekly 45-minute modules delivered one-on-one immediately following the lifestyle education class each week. Receives: Behavioral: Digital Storytelling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity/resistance
Insulin sensitivity measured by the frequently sampled IV glucose tolerance test; insulin resistance measured by HOMA insulin resistance index
Measured: Baseline and 12-weeks (post-intervention)
Secondary outcomes (2)
Physical activity
Physical activity and sedentary behavior measured by 3-day physical activity record
Measured: Baseline and 12-weeks (post-intervention)
Dietary intake
Dietary intake of macronutrients measured by 3-day diet record
Measured: Baseline and 12-weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJan 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 51 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
- NCT01895595
- Sponsor's protocol ID
- NCCAM 5 R21 AT002556
- Status last verified
- Jul 2013
- First submitted
- 1 Jul 2013
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weigensberg MJ, Lane CJ, Avila Q, Konersman K, Ventura E, Adam T, Shoar Z, Goran MI, Spruijt-Metz D. Imagine HEALTH: results from a randomized pilot lifestyle intervention for obese Latino adolescents using Interactive Guided ImagerySM. BMC Complement Altern Med. 2014 Jan 17;14:28. doi: 10.1186/1472-6882-14-28.
PubMed 24433565
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Imagery Intervention for Obese Latino Adolescents
- ClinicalTrials.gov ID
- NCT01895595
- Acronym / sponsor ID
- NCCAM 5 R21 AT002556
- Conditions
- Obesity, Insulin Resistance, Metabolic Syndrome
- Keywords
- obesity, stress, intuitive eating, guided imagery, latinos, adolescents, insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 10 Jul 2013 (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.
Guided imagery, a mind-body complementary/alternative treatment modality, offers promise to reduce stress and promote lifestyle behavior change to reduce diabetes and heart disease risk in obese Latino adolescents. The overall purpose of this study was to determine whether guided imagery, could reduce diabetes risk in obese Latino adolescents undergoing a lifestyle intervention. The specific objectives were: 1) To pilot test a new 12-week lifestyle intervention in obese Latino adolescents, in order to determine the effects of the mind-body technique of Interactive Guided ImagerySM, over and above those of healthy lifestyle education, on eating and physical activity behaviors, stress and stress biomarkers, and hormonal markers of diabetes risk; and 2) To explore the way that changes in stress produced by the intervention were associated with changes in hormonal markers of diabetes risk, particularly insulin resistance. The investigators hypothesized that participants who received guided imagery program in addition to the healthy lifestyle education would show greater improvements in insulin resistance, physical activity, dietary intake, and stress, than those receiving the healthy lifestyle education without the guided imagery. The investigators further hypothesized that reductions in stress due to the intervention would be associated with improvements in insulin resistance, a major hormonal marker of diabetes risk. For this study, obese, Latino adolescents (age 14-17) were randomized to receive either 12 weekly sessions of the lifestyle education plus guided imagery program, or lifestyle education plus a digital storytelling computer program (as a control). Outcome measures were assessed before and after the 12-week intervention, comparing the differences between the intervention groups behavioral (eating and physical activity behaviors), biological (insulin resistance and stress hormones), and psychological (stress) outcomes.
Detailed description
The current proposal pilot tests the investigators' guided imagery intervention in a limited sample of subjects in order to refine the intervention (Study 1) and then proceeds to test the intervention in a controlled, randomized trial (Study 2).
Study 1: Pilot test and refinement of guided imagery program
Specific Aim 1: To pilot, evaluate, and complete development of a guided imagery intervention program based on stress reduction and improving lifestyle behaviors for use with overweight Latino adolescents.
Outcome Objectives: Findings from Study 1 will permit us to test the intervention via a controlled, randomized trial in Study 2.
Study Design The guided imagery intervention program will be combined with a lifestyle education program and will be piloted, one module weekly for 12 weeks, in 8 overweight Latino adolescents (4 males, 4 females). Upon completion of the pilot intervention, participants will participate in an idea-building session about their experiences with the program, in order to develop ideas to add to or modify the program. Participants will discuss the acceptability, cultural relevance, developmental appropriateness and obstacles to efficacy and delivery of the program. The information from these sessions will be analyzed in order to improve the intervention's developmental and cultural relevance and appeal. Analyses of the idea-building data will be similar to analyses used for focus group data, including recording, transcription, and examination of the data for emergent themes. Based on information obtained during the pilot study and from the idea-building sessions, the program will be modified for the intervention study, Study 2.
Study 2: Clinical trial of guided imagery program intervention Specific Aim 2 : To conduct a randomized and controlled trial to test the direct and mediated effects of adding a guided imagery intervention program to a lifestyle education program. Major outcomes will include insulin sensitivity, psychosocial measures, and dietary and physical activity behaviors.
Hypotheses
- The addition of a guided imagery intervention program to a lifestyle education program will be more effective than the lifestyle education program alone in increasing insulin sensitivity (independent of body fat), improving body composition, reducing stress hormone (cortisol) secretion, and decreasing cardiovascular risk factors.
- The addition of a guided imagery intervention program will be more effective than the lifestyle education alone in improving health-promoting dietary and physical activity behaviors.
- The guided imagery intervention program will change behavior and physiology through lowering stress and through changing the meanings of dietary and physical activity behaviors.
Study Design This study is a 12-week randomized, controlled clinical trial. After collection of baseline psychosocial, behavioral, and metabolic outcome measurements, participants will be randomly assigned to either "Treatment Group" with guided imagery program + lifestyle education (n = 20), or "Control Group" with the same lifestyle education + digital storytelling program to ensure equal contact time (n = 20). At the end of the 12-week treatment period, all baseline measures will be repeated, and differences in outcome variables between groups will be assessed.
Inclusion Criteria: see below
Exclusion Criteria: see below
Participant Recruitment: Clinic-based recruitment, past lists of potential recruits from our prior studies, referrals from hospital, local health fairs, and extensive word of mouth.
12-Week Intervention Participants will be randomized to treatment group (lifestyle program plus guided imagery, n=20) or control group (lifestyle program alone, n=20), stratified by sex in order to ensure equal numbers of girls and boys in each study group.
Control and Treatment (guided imagery) interventions will be delivered in weekly, 1.5 hour sessions over a 12-week period in the late afternoon after school. Each session will begin with a 45-minute lifestyle education component delivered in groups of 4-8 subjects, followed immediately by an individual 45 minute guided imagery module for each subject in the Treatment Group, or an individual 45 minute Digital Storytelling module for each subject in the Control Group, in order to ensure equal contact time.
The lifestyle education program curriculum consists of 12 weekly modules focused on decreased intake of added sugars and increased intake of whole grains and fiber in the diet, combined with the non-dieting philosophy of intuitive eating. Educational content relating to principals of healthy nutrition and physically active lifestyle contained within the proposed lifestyle education curriculum are fully consistent with expert committee recommendations for obesity intervention in adolescents.
The guided imagery program curriculum consists of 12 weekly, one-on-one imagery modules based on 2 major underlying theoretical principles: 1) relaxation/stress reduction imagery; and 2) imagery designed to improve eating and physical activity behaviors. The protocol of each one-on-one imagery module will follow the standard procedures of Interactive Guided ImagerySM, consisting of 3 essential aspects: 1) foresight (identification of the issue to be addressed in imagery); 2) insight (the facilitated imagery experience itself); 3) hindsight (discussion and integration of the imagery experience).
The digital storytelling program curriculum, to control for contact time with research staff, consists of 12 weekly 45-minute modules delivered one-on-one immediately following the lifestyle education class each week. Subjects will learn to create and edit their own short films by writing a script, gathering media (images and music), and editing the complete product. The subjects will be free to choose their own topic for their project, excluding topics relating to obesity or health behaviors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Imagery | Experimental | Behavioral: Guided ImageryThe guided imagery program curriculum, added to the lifestyle education curriculum, consists of 12 weekly, 45-minute modules, delivered one-on-one immediately following the lifestyle education class each week. Guided imagery was based on 2 major underlying theoretical principles: 1) relaxation/stress reduction imagery; and 2) imagery designed to improve eating and physical activity behaviors. |
| Digital storytelling ("Control") | Active comparator | Behavioral: Digital StorytellingThe digital storytelling program curriculum, to control for contact time with research staff, consists of 12 weekly 45-minute modules delivered one-on-one immediately following the lifestyle education class each week. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 14-17, girls and boys; enrolled/attending high school
- Latino ethnicity (self-reported all 4 grandparents of Latino heritage);
- Obese: BMI > 95th percentile for age and gender
- Live within 10 mile radius of medical center
Key exclusion criteria (10 listed)
- Participation in any weight loss program, or weight loss of 5% or more of body weight, within the 6 months preceding entry to study
- Regular participation (present or past) in mind-body stress reduction/ relaxation practices such as meditation, hypnotherapy, yoga, biofeedback, etc.
- Serious chronic illness; or physical, cognitive or behavioral disability that would prevent ability to fully receive intervention.
- Prior diagnosis of medical condition or medication that may effect body composition or insulin sensitivity/secretion (e.g. diabetes, untreated hypothyroidism, prednisone).
- Prior diagnosis of clinical eating disorder or psychiatric disorder.
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 |
|---|---|---|
| Guided Imagery | Behavioural | Guided Imagery |
| Digital Storytelling | Behavioural | Digital storytelling ("Control") |
Primary outcome
Insulin sensitivity/resistance
Time frame: Baseline and 12-weeks (post-intervention)
Insulin sensitivity measured by the frequently sampled IV glucose tolerance test; insulin resistance measured by HOMA insulin resistance index
2 secondary outcomes
Physical activity
Time frame: Baseline and 12-weeks (post-intervention)
Dietary intake
Time frame: Baseline and 12-weeks (post-intervention)
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 10 Jul 2013.
- Derived from this study: PubMed 24433565Weigensberg MJ, Lane CJ, Avila Q, Konersman K, Ventura E, Adam T, Shoar Z, Goran MI, Spruijt-Metz D. Imagine HEALTH: results from a randomized pilot lifestyle intervention for obese Latino adolescents using Interactive Guided ImagerySM. BMC Complement Altern Med. 2014 Jan 17;14:28. doi: 10.1186/1472-6882-14-28.
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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 Guided Imagery and Digital Storytelling 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 4 inclusion and 10 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 10 Jul 2013. 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?
Insulin sensitivity/resistance (time frame: Baseline and 12-weeks (post-intervention)). 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 NCT01895595, which also lists 1 linked publication.
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 10 Jul 2013.