- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02088294
Guided Imagery Lifestyle Intervention to Promote Health and Prevent Diabetes in Youth
12 października 2018 zaktualizowane przez: Marc Weigensberg, University of Southern California
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.
Przegląd badań
Status
Zakończony
Warunki
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
240
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
California
-
Los Angeles, California, Stany Zjednoczone, 90033
- University of Southern California
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
14 lat do 17 lat (Dziecko)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Brak interwencji: Non-intervention control
No intervention will be delivered.
|
|
|
Eksperymentalny: 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 .
|
See arm description
|
|
Eksperymentalny: LS + Stress Reduction Guided Imagery
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.
|
See arm description
See Arm Description
|
|
Eksperymentalny: LS + Activity/Eating Guided Imagery
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.
|
See arm description
See arm description
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Physical activity
Ramy czasowe: 3 months
|
Physical activity and sedentary behavior will be measured by accelerometry and 3-day physical activity recall.
|
3 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Salivary Cortisol, daily slope
Ramy czasowe: 3 months
|
Salivary cortisol will be collected on 3 successive days at awakening, 30-minutes post-awakening, and in the evening.
|
3 months
|
|
Change in Dietary intake
Ramy czasowe: 3 months
|
Dietary intake of macronutrients measured by 3-day diet record
|
3 months
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Perceived Stress
Ramy czasowe: 3 months
|
Measured by Perceived Stress Scale
|
3 months
|
|
Change in Well-Being
Ramy czasowe: 3 months
|
Measured by Psychological General Well-Being Index (GWBS) and the Arizona Integrated Outcomes Scale.
|
3 months
|
|
Change in Adiposity
Ramy czasowe: 3 months
|
BMI will be determined based on standards for age and sex, using clinical balance and stadiometer.
Percent body fat will be determined by bioimpedance.
|
3 months
|
|
Change in Insulin resistance
Ramy czasowe: 3 months
|
The Homeostatic Model Insulin Resistance Index will be determined based on measures of fasting glucose and insulin.
|
3 months
|
|
Change in Carotid artery intima media thickness
Ramy czasowe: 15 months
|
Determined by carotid artery ultrasound.
|
15 months
|
|
Change in Self-determination Theory Constructs
Ramy czasowe: 3 months
|
Constructs 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.
|
3 months
|
|
Change in Intuitive eating
Ramy czasowe: 3 months
|
Intuitive Eating Scale measures attitudes and behaviors relating to intuitive eating.
|
3 months
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 maja 2014
Zakończenie podstawowe (Rzeczywisty)
27 kwietnia 2018
Ukończenie studiów (Rzeczywisty)
31 lipca 2018
Daty rejestracji na studia
Pierwszy przesłany
26 lutego 2014
Pierwszy przesłany, który spełnia kryteria kontroli jakości
12 marca 2014
Pierwszy wysłany (Oszacować)
14 marca 2014
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
17 października 2018
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
12 października 2018
Ostatnia weryfikacja
1 października 2018
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- NCCAM 1 RO1 AT008330-01
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .