ObeSity and Jobs in SoCioeconomically Disadvantaged CommUnities: A Randomized CLinical Precision Public HealTh Intervention --The SCULPT-Job Study

NCT ID: NCT04709549

Last Updated: 2024-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-10

Study Completion Date

2024-01-20

Brief Summary

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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

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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.

Conditions

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Weight Maintenance Weight Loss Stress, Psychological Job Stress Diabetes Prevention Obesity Cardiovascular Risk Factor Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Due to the nature of lifestyle behavioral intervention, the study design prevents participants and study staff blinding to allocation. However, to minimize bias, outcomes will be assessed by independent study staff blinded to allocation status.

Study Groups

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Diabetes Prevention Program

The DPP is a behavioral obesity and diabetes prevention program run by the YMCA, over a 12-month period.

Group Type ACTIVE_COMPARATOR

Diabetes Prevention Program

Intervention Type BEHAVIORAL

Diabetes Prevention Program (DPP) is a one-year lifestyle modification program that helps adults at risk for developing type 2 diabetes gain tools for healthy living.

Diabetes Prevention Program + Job and Legal Services

Participants meet with service connectors to receive an individual assessment of your needs and create an individual service plan for job services and be referred to legal support services if also needed.

Group Type EXPERIMENTAL

Diabetes Prevention Program + Job and Legal Services

Intervention Type BEHAVIORAL

Diabetes Prevention Program (DPP) is a one-year lifestyle modification program that helps adults at risk for developing type 2 diabetes gain tools for healthy living.

Job readiness services will be provided by YMCA SF service connectors, trained staff with expertise in employment services who are bi-lingual in English/Spanish and/or Cantonese/English to serve the needs of the community. Service Connectors will assist with providing employment services (e.g job search, potential placement and retention services, relationship development with partners and employers) and job readiness instruction/training.

Interventions

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Diabetes Prevention Program + Job and Legal Services

Diabetes Prevention Program (DPP) is a one-year lifestyle modification program that helps adults at risk for developing type 2 diabetes gain tools for healthy living.

Job readiness services will be provided by YMCA SF service connectors, trained staff with expertise in employment services who are bi-lingual in English/Spanish and/or Cantonese/English to serve the needs of the community. Service Connectors will assist with providing employment services (e.g job search, potential placement and retention services, relationship development with partners and employers) and job readiness instruction/training.

Intervention Type BEHAVIORAL

Diabetes Prevention Program

Diabetes Prevention Program (DPP) is a one-year lifestyle modification program that helps adults at risk for developing type 2 diabetes gain tools for healthy living.

Intervention Type BEHAVIORAL

Other Intervention Names

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DPP + Job and Legal Services DPP

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle A Albert, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, SF

Locations

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YMCA-Bayview

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 14569036 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10681894 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17875256 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16259149 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17365120 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7080884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28938955 (View on PubMed)

Other Identifiers

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18-26093

Identifier Type: -

Identifier Source: org_study_id

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