Trial Outcomes & Findings for Physical Health in Midlife: Influences of Adversity and Relationships Over Time (NCT NCT01853332)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

210 participants

Primary outcome timeframe

2.5 years

Results posted on

2017-07-24

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	210
Overall Study COMPLETED	151
Overall Study NOT COMPLETED	59

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cross-Sectional n=151 Participants New and Former Participants
Age, Continuous	45.6 years STANDARD_DEVIATION 3.5 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2.5 years

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.

Outcome measures

Outcome measures
Measure	Cross-Sectional n=151 Participants New participants and former participants
Hormonal Levels glucose	910000 ng/ml Interval 840000.0 to 960000.0
Hormonal Levels insulin	5.8 ng/ml Interval 3.2 to 10.3
Hormonal Levels adipokines (leptin)	22.8 ng/ml Interval 6.9 to 37.0
Hormonal Levels myokines (irisin)	171.8 ng/ml Interval 142.5 to 214.2
Hormonal Levels triglycerides	820000 ng/ml Interval 600000.0 to 1170000.0
Hormonal Levels HDL-cholesterol	530000 ng/ml Interval 450000.0 to 650000.0
Hormonal Levels proinflammatory markers (CRP)	16000 ng/ml Interval 6000.0 to 37000.0

PRIMARY outcome

Timeframe: 2.5 years

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).

Outcome measures

Outcome measures
Measure	Cross-Sectional n=151 Participants New participants and former participants
Psychosocial Adversity Cumulative Adversity Score	3.24 units on a scale Standard Deviation 2.73
Psychosocial Adversity Overall Childhood Adversity	22.41 units on a scale Standard Deviation 29.98
Psychosocial Adversity Social Adjustment Scale	2.47 units on a scale Standard Deviation 1.21
Psychosocial Adversity Psychosocial Risk Factors	1.03 units on a scale Standard Deviation 0.88

PRIMARY outcome

Timeframe: 2.5 years

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).

Outcome measures

Outcome measures
Measure	Cross-Sectional n=151 Participants New participants and former participants
Psychosocial Health Risk Factors Correlated With BMI Cumulative Adversity Score with BMI	0.17 Pearson Correlation Coefficients
Psychosocial Health Risk Factors Correlated With BMI Psychosocial Risk Factors with BMI	0.23 Pearson Correlation Coefficients
Psychosocial Health Risk Factors Correlated With BMI Social Adjustment with BMI	-0.17 Pearson Correlation Coefficients
Psychosocial Health Risk Factors Correlated With BMI Cumulative Adversity Score with Health Risk Factor	0.14 Pearson Correlation Coefficients
Psychosocial Health Risk Factors Correlated With BMI Psychosocial Risk Factors with Health Risk Factors	0.49 Pearson Correlation Coefficients
Psychosocial Health Risk Factors Correlated With BMI Social Adjustment with Health Risk Factors	0.45 Pearson Correlation Coefficients

PRIMARY outcome

Timeframe: 2.5 years

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%).

Outcome measures

Outcome measures
Measure	Cross-Sectional n=151 Participants New participants and former participants
Social Adjustment Scale	2.47 units on a scale Standard Deviation 1.21

SECONDARY outcome

Timeframe: cross-sectional

BMI is calculated as weight in kilograms divided by height in meters squared.

Outcome measures

Outcome measures
Measure	Cross-Sectional n=151 Participants New participants and former participants
Body Mass Index (BMI)	30.41 kg/m^2 Standard Deviation 7.22

SECONDARY outcome

Timeframe: cross-sectional

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).

Outcome measures

Outcome measures
Measure	Cross-Sectional n=151 Participants New participants and former participants
Health Risk Factors	1.33 sum of health risk factors Standard Deviation 1.06

Adverse Events

Cross-Sectional

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christos Mantzoros

Beth Israel Deaconess Medical Center

Phone: 6176678630

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place