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

NCT ID: NCT01853332

Last Updated: 2017-07-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2014-05-31

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

Detailed Description

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:

1. Glucose finger stick for diabetes screening

2. Vital signs (such as blood pressure) and anthropometrics (such as waist circumference).

3. Measuring the amount of fat in the patient's body using bioelectrical impedance analysis. This test will measure the resistance to the naturally occurring flow of electrical currents within the nerves and muscles using a few electrical sensors (similar to the EKG) attached to the patient's wrist and ankle for less than a minute. This procedure is not painful and uses the same principle as weighing oneself on a scale that provides body mass index.

4. Measuring the patient body's ability to use sugar through an oral glucose tolerance test (OGTT). A nurse will place an intravenous (IV) catheter (a small tube) in the patient's arm. It will be taped to stay in place for approximately four hours. The patient will drink a mixed nutrient drink called Boost. The patient's blood will be drawn through the catheter 15 min after the Boost is given and then at 30-minute intervals for 3 hours to measure how they metabolize the nutrient drink.

5. EKG

Conditions

Cardiovascular Disease; Type 2 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

1. 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.

2. 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Judge Baker Children's Center

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Christos Mantzoros

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christos Mantzoros, MD, DSc

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Judge Baker Children's Center

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25912185 (View on PubMed)

Other Identifiers

R01AG032030

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2008P000424

Identifier Type: -

Identifier Source: org_study_id