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

Obesity Clinical Trial

— SCULPT-Job  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04709549
• Other study ID #: 18-26093
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: January 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: January 31, 2024
• Est. primary completion date: January 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	YMCA-Bayview	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	American Heart Association

Country where clinical trial is conducted

United States, 

References & Publications (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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Impulsivity	The following indicators will be obtained: Self-reported indicators of trait impulsivity via the Barratt Impulsiveness Scale.	Baseline and 12 month
Secondary	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
Secondary	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