Physical Health in Midlife: Influences of Adversity and Relationships Over Time

NCT01853332 | Completed Results

• 2 other identifiers: 2008P000424R01AG032030
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Disease; Type 2 Diabetes

Keywords

Cardiovascular Disease; Diabetes; Adjustment; Adversity; Psychology; Midlife; Functioning; Socioeconomic; Psychosocial outcomes

Outcome Measures

Primary Outcomes (4)

• 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. 1. Both insulin and glucose will be measured. 2. Adipokines. 3. Myokines. 4. Triglycerides and HDL cholesterol will be considered in light of their relevance to CVD. 5. Proinflammatory markers.

  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).

  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

Secondary Outcomes (2)

• Body Mass Index (BMI)

  cross-sectional

• Health Risk Factors

  cross-sectional

Study Arms (2)

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.

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male and female participants between 35 and 55 years of age.

You may not qualify if:

• Abnormal hepatic function (liver function tests \>2X upper normal);
• abnormal renal function (creatinine \>1.3 mg/dl);
• conditions/illnesses such as active infection, significant malabsorption/malnutrition, cancer;
• active hormonal disease such as overt hypo/hyperthyroidism, hypogonadism, hyper-cortisolism, or treatment with steroids or growth hormone.
• Known Diabetes Mellitus (DM) and Cardiovascular Disease (CVD) will be screened for by a detailed history and systems review.
• Baseline laboratory analysis with chemistries, CBC, hormone levels, and EKG will be completed.
• Original subjects with DM or CVD will not be excluded, since that would result in bias in that sample and loss of opportunity to examine predictors associated with these outcomes.
• Community adults diagnosed with these disorders at the screening visit will be retained and referred for medical treatment as needed. In both groups, those with DM and/or CVD will be followed for psychosocial and relevant biomedical variables, excluding assessments interfered with by CVD and DM relevant medications. Those with DM and CVD will at times be separately analyzed, together with participants who develop these disorders in the years of this new study phase.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Judge Baker Children's Center: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Judge Baker Children's Center

Boston, Massachusetts, 02120, United States

Location

Related Publications (1)

• 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.

  PMID: 25912185 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma are stored to be analyzed for biomarkers related to metabolic syndrome.

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Christos Mantzoros
• Organization: Beth Israel Deaconess Medical Center

cmantzor@bidmc.harvard.edu

6176678630

Study Officials

• Christos Mantzoros, MD, DSc

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 15, 2013
• Study Start: January 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 24, 2017
• Results First Posted: July 24, 2017

Record last verified: 2017-04

Locations

US (1)