Clinical trial NCT06965075: The SCULPT-Job Cohort Study
Official title: ObeSity and Jobs in SoCioeconomically Disadvantaged CommUnities --The SCULPT-Job Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Weight Maintenance
Weight Loss
Stress, Psychological
Job Stress
Diabetes Prevention
Obesity
Cardiovascular Risk Factor
Cardiovascular Diseases
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2025-05-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is an research study about clinical, psychosocial, and behavioral factors that impact weight loss, weight maintenance, and cardiovascular disease in socially disadvantaged persons.

Detailed description: This study aims to evaluate the impact of the Diabetes Prevention Program (DPP) at 12 months among socioeconomically diverse participants by examining: changes in body mass index (BMI); improvements in ideal cardiovascular health scores (based on AHA 2020 goals and Life's Essential 8, where sleep data is available); and reductions in psychosocial stress.

Eligibility criteria: Inclusion Criteria:

•. Inlcudes participants from socioeconomically diverse backgrounds, age \> 18 years old, and BMI \> 25 kg/m2 (for Asian ethnicity BMI\> 22 kg/m2).

Exclusion criteria will include pregnancy or post-partum state (\< 12 months post-partum), history of diabetes (type 1 or 2), history of myocardial infarction, stroke or cardiac arrest in the prior 2 years, history of physician diagnosed cognitive, developmental or psychiatric conditions, recent orthopedic diagnosis or surgery (\< 6 months) , inability to speak English, Spanish, or Chinese, persons facing housing eviction or undergoing an active housing leasing process (e.g getting their credit report in shape for a potential lease, in the process of getting a new housing lease).

Primary outcomes:
measure: BMI Change
timeFrame: Baseline and 12 month
measure: BMI Maintenance
timeFrame: Baseline and 12 month
measure: Ideal Cardiovascular Health
timeFrame: 12 month and 18 months
Secondary outcomes:
measure: Cumulative Stress
timeFrame: Baseline and 12 month
measure: Impulsivity
timeFrame: Baseline and 12 month
measure: Cellular Aging Biomarkers
timeFrame: Baseline and 12 month
measure: Binge Eating
timeFrame: Baseline and 12 month
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: YMCA-Bayview
state: California
Study officials:
affiliation: University of California, SF
name: Michelle A Albert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Kumanyika SK, Whitt-Glover MC, Gary TL, Prewitt TE, Odoms-Young AM, Banks-Wallace J, Beech BM, Halbert CH, Karanja N, Lancaster KJ, Samuel-Hodge CD. Expanding the obesity research paradigm to reach African American communities. Prev Chronic Dis. 2007 Oct;4(4):A112. Epub 2007 Sep 15.
citation: 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.
citation: 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.
citation: 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.
citation: 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.