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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG032030 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Judge Baker Children's Center | OTHER |
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to determine the effects of individual characteristics, life stresses, and relationships over time on psychosocial outcomes (e.g. marriage, parenting, work) and physical health
Research Procedures: If a patient choose to take part in this research study, they will undergo these research procedures:
The patient will participate in a total of two meetings and four phone calls over the course of the study (two and a half years). The meetings will be held at the beginning and end of the two and a half year period. The first part of each meeting will take place at Beth Israel Deaconess Medical Center (BIDMC) where they will sign this consent form and then be interviewed for medical history, given a physical examination, and have blood tests described below. The patient will then be transported to Judge Baker Children's Center (JBCC), where they will have lunch, complete questionnaires, and participate in taped interviews (approximately 4 hours). The phone calls will be approximately every six months and the patient will be contacted by the people at JBCC. More detailed information on the study procedures is outlined below and on the JBCC consent form for the study.
Interviews, Questionnaires, and Phone calls: These aspects of the study are covered in the Judge Baker Children's Center consent form. Briefly, the patient will be asked to discuss relationships with their partner, family, and friends, their career, their current goals in life, their health status, etc. These sessions will be recorded so that the patient's answers can be coded and analyzed at a later time. All information will be kept strictly confidential.
Medical Examination: The patient will arrive fasting to the medical examination. During the medical exam, a physician will ask the patient questions about their physical health and family history. The doctor will then conduct a physical examination which includes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cross-Sectional | New participant: The purpose of the study is to learn about physical health in midlife and how it has been influenced by experiences and relationships. The study specifically targets health differences and the development of heart disease and diabetes. | ||
| Longitudinal | Former participants (or the partner of a former participant) of the Adolescent and Family Development Project, Young Adult Development Project, Across Generations Project, and/or Paths Over Time Project may already know that this research shows how people grow, individually and as part of a familial and social network, throughout the course of life. This study focuses on learning about former participants' physical health in midlife and how it has been influenced by their experiences and relationships. |
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| Measure | Description | Time Frame |
|---|---|---|
| Hormonal Levels | To assess clinically significant physical health outcomes including 1) establishing risk factors for CVD and type 2 diabetes mellitus (DM) 2) establishing novel risk factors for CVD and DM (e.g., inflammatory markers, hormonal mediators ), and 3) determining the prevalence of established CVD and DM.
| 2.5 years |
| Psychosocial Adversity | Cumulative adversity occurring before age 18 was assessed using a) the Evaluation of Lifetime Stressors, b) SCID, and c) the Adult Attachment Interview. A cumulative adversity sum score was obtained (range 0-13, higher more).An overall adversity score was created by multiplying the number of childhood adversities×the overall severity of childhood adversity × the overall chronicity of childhood adversity. Scores for overall adversity ranged from 0 (no) to 156 more adversity).The Social Adjustment Scale is a semi-structured interview assessing functioning in the preceding 2 months and ranges from 1 (excellent) to 7 (very poor adjustment). An index score of psychosocial risk factors was created. Education less than a Bachelor's degree, unemployment, and a social adjustment scale score indicative of non-optimal functiong (≥ 3) were considered risk factors, coded as "1", and then tallied. Range of scores 0 (less)-3 (more risk). | 2.5 years |
| Psychosocial Health Risk Factors Correlated With BMI | Correlations of scales with BMI score. Cumulative adversity occurring before age 18 was assessed using a) the Evaluation of Lifetime Stressors, b) SCID, and c) the Adult Attachment Interview. A cumulative adversity sum score was obtained (range 0-13; higher is more adversity). An overall adversity score was created by multiplying the number of childhood adversities × the overall severity of childhood adversity × the overall chronicity of childhood adversity. Scores for overall adversity ranged from 0 to 156 (higher is more adversity). The Social Adjustment Scale is a semi-structured interview assessing functioning in the preceding 2 months and ranges from 1 (excellent adjustment) to 7 (very poor adjustment). Psychosocial risk factors is an index of 1 to 3 (higher is more risk). Health risk score adds smoking, non-optimal drinking (>7/14 drinks/week for women/men), a score in the bottom tertile of the AHEI, and minimal exercise (<6 hours/week)and tallied (scores0-4 with higher worse). |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) | BMI is calculated as weight in kilograms divided by height in meters squared. | cross-sectional |
| Health Risk Factors | An index score of health behavior risk factors was created. Any amount of smoking, non-optimal drinking (≥ 7 drinks per week for women; ≥ 14 drinks per week for men), a score in the bottom tertile of the AHEI, and minimal exercise (< 6 metabolic hours per week) were considered risk factors, coded as "1", and then tallied. The range of scores for health risk factors in the current sample was between 0 and 4 health risk factors (where 4 is more risk factors). |
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Inclusion Criteria:
Exclusion Criteria: (based on interference with key assessments)
Two exceptions will be made to the usual exclusion criteria:
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Approximately 165 former participants and 250 new participants will take part in this study at Beth Israel Deaconess Medical Center (and Judge Baker Children's Center). The new sample will include 250 African American and Black Caribbean midlife men and women with the goal of recruiting 80% as couples. A total of 415 people will take part in this study at all study sites. Spouses and long-term significant others (with bonuses to couples for joining) will be encourage to also participate in the study. Targeting couples in this way will be parallel for the community and longitudinal samples
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| Name | Affiliation | Role |
|---|---|---|
| Christos Mantzoros, MD, DSc | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Judge Baker Children's Center | Boston | Massachusetts | 02120 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25912185 | Derived | Ko BJ, Park KH, Shin S, Zaichenko L, Davis CR, Crowell JA, Joung H, Mantzoros CS. Diet quality and diet patterns in relation to circulating cardiometabolic biomarkers. Clin Nutr. 2016 Apr;35(2):484-490. doi: 10.1016/j.clnu.2015.03.022. Epub 2015 Apr 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cross-Sectional | New participants: The purpose of the study is to learn about physical health in midlife and how it has been influenced by experiences and relationships. The study specifically targets health differences and the development of heart disease and diabetes. AND Former participants (or the partner of a former participant) of the Adolescent and Family Development Project, Young Adult Development Project, Across Generations Project, and/or Paths Over Time Project may already know that this research shows how people grow, individually and as part of a familial and social network, throughout the course of life. This study focuses on learning about former participants' physical health in midlife and how it has been influenced by their experiences and relationships. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cross-Sectional | New and Former Participants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hormonal Levels | To assess clinically significant physical health outcomes including 1) establishing risk factors for CVD and type 2 diabetes mellitus (DM) 2) establishing novel risk factors for CVD and DM (e.g., inflammatory markers, hormonal mediators ), and 3) determining the prevalence of established CVD and DM.
| Posted | Mean | Inter-Quartile Range | ng/ml | 2.5 years |
|
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at cross-sectional or longitudinal visit
Adverse Events would be those noticed at a visit. As no interventions were given/this is an observational study, no adverse events were expected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cross-Sectional | New and Former Participants | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christos Mantzoros | Beth Israel Deaconess Medical Center | 6176678630 | cmantzor@bidmc.harvard.edu |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Serum and plasma are stored to be analyzed for biomarkers related to metabolic syndrome.
| 2.5 years |
| Social Adjustment Scale | The Social Adjustment Scale is a semi-structured interview assessing functioning in the preceding 2 months in domains of work (including employment functioning, homemaking and other household functions, and/or student/educational functioning), friendships/leisure, and relationships with extended family. If applicable, relationships with immediate family members (spouse/partner and/or children) are also assessed. The SAS is closely linked to mental health and can be used as a tool for assessing treatment response to psychotropic medications or therapies. Positive adjustment is the ability to carry out each activity/role effectively, deriving satisfaction/support from that domain, whereas poor adjustment reflects maladaptation, dissatisfaction, disengagement, and/or discord. Scores range from 1 (excellent adjustment) to 7 (very poor adjustment). Coding was completed during an audio-recorded interview; 12% were coded for agreement (91%). | 2.5 years |
| cross-sectional |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Psychosocial Adversity | Cumulative adversity occurring before age 18 was assessed using a) the Evaluation of Lifetime Stressors, b) SCID, and c) the Adult Attachment Interview. A cumulative adversity sum score was obtained (range 0-13, higher more).An overall adversity score was created by multiplying the number of childhood adversities×the overall severity of childhood adversity × the overall chronicity of childhood adversity. Scores for overall adversity ranged from 0 (no) to 156 more adversity).The Social Adjustment Scale is a semi-structured interview assessing functioning in the preceding 2 months and ranges from 1 (excellent) to 7 (very poor adjustment). An index score of psychosocial risk factors was created. Education less than a Bachelor's degree, unemployment, and a social adjustment scale score indicative of non-optimal functiong (≥ 3) were considered risk factors, coded as "1", and then tallied. Range of scores 0 (less)-3 (more risk). | Posted | Mean | Standard Deviation | units on a scale | 2.5 years |
|
|
|
| Primary | Psychosocial Health Risk Factors Correlated With BMI | Correlations of scales with BMI score. Cumulative adversity occurring before age 18 was assessed using a) the Evaluation of Lifetime Stressors, b) SCID, and c) the Adult Attachment Interview. A cumulative adversity sum score was obtained (range 0-13; higher is more adversity). An overall adversity score was created by multiplying the number of childhood adversities × the overall severity of childhood adversity × the overall chronicity of childhood adversity. Scores for overall adversity ranged from 0 to 156 (higher is more adversity). The Social Adjustment Scale is a semi-structured interview assessing functioning in the preceding 2 months and ranges from 1 (excellent adjustment) to 7 (very poor adjustment). Psychosocial risk factors is an index of 1 to 3 (higher is more risk). Health risk score adds smoking, non-optimal drinking (>7/14 drinks/week for women/men), a score in the bottom tertile of the AHEI, and minimal exercise (<6 hours/week)and tallied (scores0-4 with higher worse). | Posted | Number | Pearson Correlation Coefficients | 2.5 years |
|
|
|
| Primary | Social Adjustment Scale | The Social Adjustment Scale is a semi-structured interview assessing functioning in the preceding 2 months in domains of work (including employment functioning, homemaking and other household functions, and/or student/educational functioning), friendships/leisure, and relationships with extended family. If applicable, relationships with immediate family members (spouse/partner and/or children) are also assessed. The SAS is closely linked to mental health and can be used as a tool for assessing treatment response to psychotropic medications or therapies. Positive adjustment is the ability to carry out each activity/role effectively, deriving satisfaction/support from that domain, whereas poor adjustment reflects maladaptation, dissatisfaction, disengagement, and/or discord. Scores range from 1 (excellent adjustment) to 7 (very poor adjustment). Coding was completed during an audio-recorded interview; 12% were coded for agreement (91%). | Posted | Mean | Standard Deviation | units on a scale | 2.5 years |
|
|
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| Secondary | Body Mass Index (BMI) | BMI is calculated as weight in kilograms divided by height in meters squared. | Posted | Mean | Standard Deviation | kg/m^2 | cross-sectional |
|
|
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| Secondary | Health Risk Factors | An index score of health behavior risk factors was created. Any amount of smoking, non-optimal drinking (≥ 7 drinks per week for women; ≥ 14 drinks per week for men), a score in the bottom tertile of the AHEI, and minimal exercise (< 6 metabolic hours per week) were considered risk factors, coded as "1", and then tallied. The range of scores for health risk factors in the current sample was between 0 and 4 health risk factors (where 4 is more risk factors). | Posted | Mean | Standard Deviation | sum of health risk factors | cross-sectional |
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| 151 |
| 0 |
| 151 |
| 0 |
| 151 |
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| Title | Measurements |
|---|---|
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| Psychosocial Risk Factors |
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| Title | Measurements |
|---|---|
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| Cumulative Adversity Score with Health Risk Factor |
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| Psychosocial Risk Factors with Health Risk Factors |
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| Social Adjustment with Health Risk Factors |
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