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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: Diabetes Prevention Program + Job and Legal Services
* Behavioral: Diabetes Prevention Program


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diabetes Prevention Program<br>The DPP is a behavioral obesity and diabetes prevention program run by the YMCA, over a 12-month period. | Behavioral: Diabetes Prevention Program<br>* 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.<br>* Other names: DPP;|
| Experimental: Diabetes Prevention Program + Job and Legal Services<br>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<br>* 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.<br>* Other names: DPP + Job and Legal Services;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Impulsivity | The following indicators will be obtained: Self-reported indicators of trait impulsivity via the Barratt Impulsiveness Scale. | Baseline and 12 month | 
| 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 | 
| 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 |