The SCULPT-Job Cohort Study (SCULPT-Job)

ObeSity and Jobs in SoCioeconomically Disadvantaged CommUnities --The SCULPT-Job Study

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Obesity; Stress, Psychological; Weight Loss; Cardiovascular Risk Factor; Diabetes Prevention; Job Stress; Weight Maintenance
• Intervention / Treatment: Behavioral: Diabetes Prevention Program

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94124
      • YMCA-Bayview

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diabetes Prevention Program; The DPP is a behavioral obesity and diabetes prevention program run by the YMCA, over a 12-month period.	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.; Other Names: DPP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI Change	Weight will be measured using a calibrated digital scale to the nearest 0.1 kg. Height will be measured using a stadiometer. Waist and hip measurements will be performed using vinyl retractable tape to the nearest 0.1 cm at the smallest horizontal portion of the waist (highest horizontal point of the iliac crest with minimal respiration) and largest area of the hip.	Baseline and 12 month
BMI Maintenance	The primary analysis of the maintenance phase will include 18-month outcomes, allowing 0-to-12 and 12-to-18 month linear changes by study arm. This model will estimate and compare mean (95% CI) 0-to-18 month changes by study arm: under the hypothesis that differential changes through month 12 will be maintained over the following 6 months, 12- and 18-month differences (95% CI) between arms will be similar (i.e., same sample size calculation). For descriptive purposes, we will compare the later slopes to quantify differential recidivism; within-arm 95% CIs that exclude positive values will demonstrate maintenance of intervention-period weight loss	Baseline and 12 month
Ideal Cardiovascular Health	AHA 2020 ideal cardiovascular health score will be used as an index about cardiovascular health consisting of health behaviors and factors. Ideal cardiovascular health is defined as: BMI < 25 kg/m2, > 150 min/week of moderate physical activity, a healthy diet pattern including sufficient amounts of fruits and vegetables, optimal blood pressure (< 120/<80 mmHg), fasting glucose (< 100 mg/dL), total cholesterol < 200, and never smoking or quit smoking for more than 12 months For analysis, the investigators will score each item-level category as (0,0.5,1), respectively. This step expands the granularity of ICH Scores from 8 to 15 values, allowing finer measure of longitudinal change during the intervention and maintenance periods. For descriptive purposes,the investigators will compare the later slopes to quantify differential recidivism; within-arm 95% CIs that exclude positive values will demonstrate maintenance of intervention-period weight loss.	Baseline and 12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Stress	The construct "cumulative psychological stress"(CPS), will be used to capture eight types of stress that commonly affect individuals over a life-course. The stressors include negative and traumatic life events, work-family stress, work, financial stress, intimate partner stress, neighborhood stress, and everyday discrimination. The questionnaire was constructed using a battery of scales approach that utilizes scales that have good psychometric properties that were assembled for the Chicago Community Health Aging (CCAHS), American Changing Lives, and Alameda County and Detroit Area Studies. Weights were assigned to each of the 8 domains comprising the cumulative stress score based on the reciprocal of the standard deviation of the scores for questions in each domain. The 8 domain-specific weighted scores were then added to create the cumulative stress score (CPS; range 16-385), with higher values representing higher stress.	Baseline and 12 month
Impulsivity	The following indicators will be obtained: Self-reported indicators of trait impulsivity via the Barratt Impulsiveness Scale.	Baseline and 12 month
Cellular Aging Biomarkers	To measure the change in telomeres, telomere length processing will be performed using finger-stick blood samples collected from participants at baseline and 12 months. Approximately 30 microliters of blood will be collected. Relative mean telomere length will be measured from DNA by a quantitative polymerase chain reaction (qPCR) assay as (T)/(S) ratio. The inter-assay coefficient of variability for telomere length measurement is 3.7%. The intra-assay coefficient of variability is 2.5% (equivalent to 0.13 kilobases/baseline mean)	Baseline and 12 month
Binge Eating	BIS captures impulsive decision making, lack of planning, and impaired attention. We will assess binge eating by evaluating binge eating frequency using the methods from the Framingham Heart Study and severity from a 16 item binge eating scale, BES.	Baseline and 12 month

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Michelle A Albert, MD, University of California, SF

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2023
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: May 1, 2025
• First Submitted That Met QC Criteria: May 1, 2025
• First Posted (Actual): May 11, 2025

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 5, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Behavioral Symptoms; Body Weight Changes; Overweight; Occupational Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Occupational Stress; Obesity; Weight Loss; Cardiovascular Diseases; Stress, Psychological
• Other Study ID Numbers: 18-26093 B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No