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

NCT04709549 | Completed

• 1 other identifier: 18-26093
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

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.

  12 month and 18 months

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 (2)

Diabetes Prevention Program

ACTIVE COMPARATOR

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 + Job and Legal Services

EXPERIMENTAL

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.

Behavioral: Diabetes Prevention Program + Job and Legal Services

Interventions

Diabetes Prevention Program + Job and Legal Services 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.

Also known as: DPP + Job and Legal Services

Diabetes Prevention Program + Job and Legal Services

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:

• 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).

You may not qualify if:

• 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).

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

Interventions

Occupations; dentin sialophosphoprotein

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

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Michelle A Albert, MD

  University of California, SF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: January 14, 2021
• Study Start: February 10, 2021
• Primary Completion: January 20, 2024
• Study Completion: January 20, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)