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

University of California San Francisco (UCSF)

Status: Completed

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

Treatments: Behavioral: Diabetes Prevention Program + Job and Legal Services; Behavioral: Diabetes Prevention Program

Study type: Interventional

Funder types: Other

Identifiers

NCT04709549

18-26093

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups

Diabetes Prevention Program

Active Comparator group

Description:

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

Treatment:

Behavioral: Diabetes Prevention Program

Diabetes Prevention Program + Job and Legal Services

Experimental group

Description:

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.

Treatment:

Behavioral: Diabetes Prevention Program + Job and Legal Services