Study Summary
This trial is looking at how well weight loss, weight maintenance, and cardiovascular disease work in people who are disadvantaged.
Eligible Conditions
- Obesity
- Weight Loss
- Job Stress
- Diabetes Prevention
- Cardiovascular Risk
- Weight Maintenance
- Stress
- Cardiovascular Disease
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 4 Secondary · Reporting Duration: 12 month and 18 months
Month 18
Ideal Cardiovascular Health
Baseline and 12 month
BMI Change
BMI Maintenance
Binge Eating
Cellular Aging Biomarkers
Cumulative Stress
Impulsivity
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Diabetes Prevention Program
1 of 2
Diabetes Prevention Program + Job and Legal Services
1 of 2
Active Control
Experimental Treatment
200 Total Participants · 2 Treatment Groups
Primary Treatment: Diabetes Prevention Program + Job and Legal Services · No Placebo Group · N/A
Diabetes Prevention Program + Job and Legal Services
Behavioral
Experimental Group · 1 Intervention: Diabetes Prevention Program + Job and Legal Services · Intervention Types: BehavioralDiabetes Prevention Program
Behavioral
ActiveComparator Group · 1 Intervention: Diabetes Prevention Program · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 month and 18 months
Who is running the clinical trial?
American Heart AssociationOTHER
284 Previous Clinical Trials
5,823,775 Total Patients Enrolled
23 Trials studying Obesity
2,446 Patients Enrolled for Obesity
University of California, San FranciscoLead Sponsor
2,288 Previous Clinical Trials
11,577,926 Total Patients Enrolled
32 Trials studying Obesity
10,679 Patients Enrolled for Obesity
Michelle A Albert, MDPrincipal InvestigatorUniversity of California, SF
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are from a disadvantaged background.
Who else is applying?
What state do they live in?
| California | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| YMCA-Bayview | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
- BAUM, ANDREW, J. P. GAROFALO, and ANN MARIE YALI. 1999. “Socioeconomic Status and Chronic Stress: Does Stress Account for SES Effects on Health?”. Annals of the New York Academy of Sciences. Wiley. doi:10.1111/j.1749-6632.1999.tb08111.x.
- Melius, Janella, Daheia J. Barr-Anderson, and Olubunmi Orekoya. 2019. “Consideration of Factors Influencing Weight Outcomes Among U.S. Racial-ethnic Minority Populations in the Social Work Literature”. Social Work in Public Health. Informa UK Limited. doi:10.1080/19371918.2019.1575309.
- Gormally, Jim, Sionag Black, Sandy Daston, and David Rardin. 1982. “The Assessment of Binge Eating Severity Among Obese Persons”. Addictive Behaviors. Elsevier BV. doi:10.1016/0306-4603(82)90024-7.
- Baranowski, Tom, Karen W. Cullen, Theresa Nicklas, Deborah Thompson, and Janice Baranowski. 2003. “Are Current Health Behavioral Change Models Helpful in Guiding Prevention of Weight Gain Efforts?”. Obesity Research. Wiley. doi:10.1038/oby.2003.222.
- Lantz, Paula M., James S. House, Richard P. Mero, and David R. Williams. 2005. “Stress, Life Events, and Socioeconomic Disparities in Health: Results from the Americans' Changing Lives Study”. Journal of Health and Social Behavior. SAGE Publications. doi:10.1177/002214650504600305.
- SPINELLA, MARCELLO. 2007. “Normative Data and A Short Form of the Barratt Impulsiveness Scale”. International Journal of Neuroscience. Informa UK Limited. doi:10.1080/00207450600588881.
- Albert, Michelle A., Eva M. Durazo, Natalie Slopen, Alan M. Zaslavsky, Julie E. Buring, Ted Silva, Daniel Chasman, and David R. Williams. 2017. “Cumulative Psychological Stress and Cardiovascular Disease Risk in Middle Aged and Older Women: Rationale, Design, and Baseline Characteristics”. American Heart Journal. Elsevier BV. doi:10.1016/j.ahj.2017.06.012.
- Gormally J, Black S, Daston S, Rardin D. The assessment of binge eating severity among obese persons. Addict Behav. 1982;7(1):47-55. doi: 10.1016/0306-4603(82)90024-7.
- Baranowski T, Cullen KW, Nicklas T, Thompson D, Baranowski J. Are current health behavioral change models helpful in guiding prevention of weight gain efforts? Obes Res. 2003 Oct;11 Suppl:23S-43S. doi: 10.1038/oby.2003.222.
- Spinella M. Normative data and a short form of the Barratt Impulsiveness Scale. Int J Neurosci. 2007 Mar;117(3):359-68. doi: 10.1080/00207450600588881.
- Albert MA, Durazo EM, Slopen N, Zaslavsky AM, Buring JE, Silva T, Chasman D, Williams DR. Cumulative psychological stress and cardiovascular disease risk in middle aged and older women: Rationale, design, and baseline characteristics. Am Heart J. 2017 Oct;192:1-12. doi: 10.1016/j.ahj.2017.06.012. Epub 2017 Jun 28.
- Baum A, Garofalo JP, Yali AM. Socioeconomic status and chronic stress. Does stress account for SES effects on health? Ann N Y Acad Sci. 1999;896:131-44. doi: 10.1111/j.1749-6632.1999.tb08111.x.
- Lantz PM, House JS, Mero RP, Williams DR. Stress, life events, and socioeconomic disparities in health: results from the Americans' Changing Lives Study. J Health Soc Behav. 2005 Sep;46(3):274-88. doi: 10.1177/002214650504600305.
- 2021. "ObeSity and Jobs in SoCioeconomically Disadvantaged CommUnities: A Randomized CLinical Precision Public HealTh Intervention --The SCULPT-Job Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04709549.
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Conditions
Cancer Related
Treatments