Clinical trial NCT01853332: Physical Health in Midlife: Influences of Adversity and Relationships Over Time
Official title: Physical Health in Midlife: Influences of Adversity and Relationships Over Time
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Type 2 Diabetes
Keywords: Cardiovascular Disease
Diabetes
Adjustment
Adversity
Psychology
Midlife
Functioning
Socioeconomic
Psychosocial outcomes
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Judge Baker Children's Center
name: National Institute on Aging (NIA)
First posted: 2013-05-15
Enrollment: 210
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria: (based on interference with key assessments)

* 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.

Two exceptions will be made to the usual exclusion criteria:

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.

Primary outcomes:
measure: Hormonal Levels
timeFrame: 2.5 years
measure: Psychosocial Adversity
timeFrame: 2.5 years
measure: Psychosocial Health Risk Factors Correlated With BMI
timeFrame: 2.5 years
measure: Social Adjustment Scale
timeFrame: 2.5 years
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: cross-sectional
measure: Health Risk Factors
timeFrame: cross-sectional
Other outcomes:
Locations:
city: Boston
country: United States
facility: Judge Baker Children's Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Christos Mantzoros, MD, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.