ObeSity and Jobs in SoCioeconomically Disadvantaged CommUnities: A Randomized CLinical Precision Public HealTh Intervention --The SCULPT-Job Study (SCULPT-Job)
Primary Purpose
Weight Maintenance, Weight Loss, Stress, Psychological
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes Prevention Program + Job and Legal Services
Diabetes Prevention Program
Sponsored by
About this trial
This is an interventional prevention trial for Weight Maintenance
Eligibility 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).
Sites / Locations
- YMCA-Bayview
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Diabetes Prevention Program
Diabetes Prevention Program + Job and Legal Services
Arm Description
The DPP is a behavioral obesity and diabetes prevention program run by the YMCA, over a 12-month period.
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.
Outcomes
Primary Outcome Measures
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.
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
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.
Secondary Outcome Measures
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.
Impulsivity
The following indicators will be obtained: Self-reported indicators of trait impulsivity via the Barratt Impulsiveness Scale.
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)
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.
Full Information
NCT ID
NCT04709549
First Posted
November 4, 2020
Last Updated
August 22, 2022
Sponsor
University of California, San Francisco
Collaborators
American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT04709549
Brief Title
ObeSity and Jobs in SoCioeconomically Disadvantaged CommUnities: A Randomized CLinical Precision Public HealTh Intervention --The SCULPT-Job Study
Acronym
SCULPT-Job
Official Title
ObeSity and Jobs in SoCioeconomically Disadvantaged CommUnities: A Randomized CLinical Precision Public HealTh Intervention --The SCULPT-Job Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
American Heart Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Maintenance, Weight Loss, Stress, Psychological, Job Stress, Diabetes Prevention, Obesity, Cardiovascular Risk Factor, Cardiovascular Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diabetes Prevention Program
Arm Type
Active Comparator
Arm Description
The DPP is a behavioral obesity and diabetes prevention program run by the YMCA, over a 12-month period.
Arm Title
Diabetes Prevention Program + Job and Legal Services
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Prevention Program + Job and Legal Services
Other Intervention Name(s)
DPP + Job and Legal Services
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Prevention Program
Other Intervention Name(s)
DPP
Intervention Description
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.
Primary Outcome Measure Information:
Title
BMI Change
Description
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.
Time Frame
Baseline and 12 month
Title
BMI Maintenance
Description
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
Time Frame
Baseline and 12 month
Title
Ideal Cardiovascular Health
Description
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.
Time Frame
12 month and 18 months
Secondary Outcome Measure Information:
Title
Cumulative Stress
Description
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.
Time Frame
Baseline and 12 month
Title
Impulsivity
Description
The following indicators will be obtained: Self-reported indicators of trait impulsivity via the Barratt Impulsiveness Scale.
Time Frame
Baseline and 12 month
Title
Cellular Aging Biomarkers
Description
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)
Time Frame
Baseline and 12 month
Title
Binge Eating
Description
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.
Time Frame
Baseline and 12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle A Albert, MD
Organizational Affiliation
University of California, SF
Official's Role
Principal Investigator
Facility Information:
Facility Name
YMCA-Bayview
City
San Francisco
State/Province
California
ZIP/Postal Code
94124
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
14569036
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.
Results Reference
background
PubMed Identifier
10681894
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.
Results Reference
background
PubMed Identifier
17875256
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.
Results Reference
background
PubMed Identifier
16259149
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.
Results Reference
background
PubMed Identifier
17365120
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.
Results Reference
background
PubMed Identifier
7080884
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.
Results Reference
background
PubMed Identifier
28938955
Citation
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.
Results Reference
background
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ObeSity and Jobs in SoCioeconomically Disadvantaged CommUnities: A Randomized CLinical Precision Public HealTh Intervention --The SCULPT-Job Study
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