Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04709549
Recruitment Status : Enrolling by invitation
First Posted : January 14, 2021
Last Update Posted : July 26, 2021
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Weight Maintenance Weight Loss Stress, Psychological Job Stress Diabetes Prevention Obesity Cardiovascular Risk Factor Cardiovascular Diseases Behavioral: Diabetes Prevention Program + Job and Legal Services Behavioral: Diabetes Prevention Program Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: ObeSity and Jobs in SoCioeconomically Disadvantaged CommUnities: A Randomized CLinical Precision Public HealTh Intervention --The SCULPT-Job Study
Actual Study Start Date : February 10, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Arm Intervention/treatment
Active Comparator: 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 Name: DPP

Experimental: Diabetes Prevention Program + Job and Legal Services
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

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.

Other Name: DPP + Job and Legal Services




Primary Outcome Measures :
  1. BMI Change [ Time Frame: Baseline and 12 month ]
    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.

  2. BMI Maintenance [ Time Frame: Baseline and 12 month ]
    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

  3. Ideal Cardiovascular Health [ Time Frame: 12 month and 18 months ]

    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.



Secondary Outcome Measures :
  1. Cumulative Stress [ Time Frame: Baseline and 12 month ]
    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.

  2. Impulsivity [ Time Frame: Baseline and 12 month ]
    The following indicators will be obtained: Self-reported indicators of trait impulsivity via the Barratt Impulsiveness Scale.

  3. Cellular Aging Biomarkers [ Time Frame: Baseline and 12 month ]

    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)


  4. Binge Eating [ Time Frame: Baseline and 12 month ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04709549


Locations
Layout table for location information
United States, California
YMCA-Bayview
San Francisco, California, United States, 94124
Sponsors and Collaborators
University of California, San Francisco
American Heart Association
Investigators
Layout table for investigator information
Principal Investigator: Michelle A Albert, MD University of California, SF
Publications:
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04709549    
Other Study ID Numbers: 18-26093
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: July 26, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases
Obesity
Body Weight
Weight Loss
Occupational Stress
Stress, Psychological
Overnutrition
Nutrition Disorders
Overweight
Body Weight Changes
Behavioral Symptoms
Occupational Diseases