The SCULPT-Job Cohort Study

NCT06965075 | Completed

• 1 other identifier: 18-26093 B
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Cumulative Stress

  Baseline and 12 month

• Impulsivity

  Baseline and 12 month

• Cellular Aging Biomarkers

  Baseline and 12 month

• Binge Eating

  Baseline and 12 month

Study Arms (1)

Diabetes Prevention Program

EXPERIMENTAL

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

Behavioral: Diabetes Prevention Program

Interventions

Diabetes Prevention Program 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.

Also known as: DPP

Diabetes Prevention Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• American Heart Association: collaborator

Study Sites (1)

YMCA-Bayview

San Francisco, California, 94124, United States

Location

Related Publications (7)

• 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.

  PMID: 14569036 BACKGROUND

• 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.

  PMID: 10681894 BACKGROUND

• 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.

  PMID: 17875256 BACKGROUND

• 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.

  PMID: 16259149 BACKGROUND

• 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.

  PMID: 17365120 BACKGROUND

• 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.

  PMID: 7080884 BACKGROUND

• 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.

  PMID: 28938955 BACKGROUND

MeSH Terms

Conditions

Weight Loss; Stress, Psychological; Occupational Stress; Obesity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Occupational Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Michelle A Albert, MD

  University of California, SF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 11, 2025
• Study Start: December 14, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)