Clinical trial NCT04709549: ObeSity and Jobs in SoCioeconomically Disadvantaged CommUnities: A Randomized CLinical Precision Public HealTh Intervention --The SCULPT-Job Study
Official title: ObeSity and Jobs in SoCioeconomically Disadvantaged CommUnities: A Randomized CLinical Precision Public HealTh Intervention --The SCULPT-Job Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
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: 2021-01-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The parallel, interventional SCULPT-Job Study model randomizes persons to either the Diabetes Prevention Program (DPP) only OR the DPP plus job readiness/legal services.
Primary purpose: PREVENTION

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

Detailed description: The purpose of this study is to understand whether the incorporation of social determinants of health into a weight loss/maintenance study, along with a known behavioral intervention will result in improved efficacy than the behavioral intervention by itself. This study will examine the role of psychosocial, clinical, and behavioral factors in the context of the intervention.

The entire duration of the study will be 18 months. Study activities will occur virtually or at YMCA locations in the city of San Francisco or at other community centers.

Eligibility criteria: Inclusion Criteria:

* Participants from disadvantaged backgrounds (average median household approximately $31,000 household income/ 4 people,
* participants in the federal Medicaid insurance program or Medical,
* age \> 18 years old,
* and BMI \> 25 kg/m2 (for Asian ethnicity BMI\> 22 kg/m2).

Exclusion Criteria:

* 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),
* and 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.