FNOA: Assessment of Overweight/Obesity (2012)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:

To identify factors associated with remaining free of chronic disease in later life.

Inclusion Criteria:
  • Men and women
  • Aged 65 years and older
  • Community dwelling
  • Did not require a proxy respondent at baseline
  • Participants in the Cardiovascular Health Study.
Exclusion Criteria:

Those who required a proxy respondent at baseline.

Description of Study Protocol:

Recruitment

Participants were recruited as part of the Cardiovascular Health Study (CHS), using Medicare eligibility lists of the Health Care Finance Administration from four communities.

Design

Prospective cohort study 

Blinding used

Implied with measurements

Intervention

Not applicable

Statistical Analysis

  • Age and cohort-adjusted bivariate association were calculated to identify behavioral and other factors that predict remaining healthy in each cohort
  • To account for different follow-up times in two different cohorts, survival analysis models were generated using time to first event as the dependent variable
  • Baseline hazard function as modeled with a Weibull distribution, and parameters were determined using SAS statistical software
  • Stepwise models were run in two stages, first to determine the most significant behavioral factors and then to identify the most significant predictors among traditional risk factors and measures of subclinical disease.

 

Data Collection Summary:

Timing of Measurements 

  • Data was collected at baseline and every six months over a maximum of seven years. There were two cohorts; one recruited in 1989-1990 and another recruited in 1992-1993. The follow-up on the second cohort averaged 3.5 years of follow-up.
  • The baseline exam consisted of a home interview and a clinic examination.

Dependent Variables

The outcomes of interest included cancer, COPD, angina, coronary angioplasty, coronary artery bypass surgery, claudification, congestive heart failure, acute myocardial infarction, stroke, transient ischemic attack or any fatal event.

  • Cancer as measured by self-report
  • CVD as verified from hospital and physician records: Subclinical measures of CVD considered included carotid artery wall thickness and ankle-arm BP index
  • COPD as measured by self-report or a physician's diagnosis
  • HTN as defined by blood pressure readings (≥160/95) using a mercury sphygmomanometer or use of hypertensive medication
  • Impaired glucose tolerance as defined according to American Diabetes Association guidelines (fasting glucose 110-125mg/dL)
  • Diabetes as defined according to American Diabetes Association guidelines (fasting glucose ≥126mg/dL) or participant was taking insulin or oral hypoglycemic agents.

Independent Variables

  • Participants were asked to fast for 12 hours and then serum was collected for a complete blood count (CBC), serum chemistry, serum insulin, plasma lipids, and coagulation factors
  • Blood pressure was measured
  • Anthropometric measurements included height, weight, waist circumference, and hip circumference 
  • Functional status was assessed using an interviewer-administered questionnaire. Self-reported difficulty in activities of daily living (ADL) and instrumental activities of daily living (IADL) were evaluated.
  • Dietary intake was assessed using a modified Block food frequency questionnaire administered via picture card of foods sorted by frequency of use
  • Participants were asked about type and frequency of exercise
  • Participants were asked about their past medical history and reported cardiovascular events were confirmed by a medical record review or by contacting the participant's physician
  • Behavioral risk factors were evaluated by self-report during the participant interviews and included physical activity, alcohol consumption, smoking status, social support, self-reported health, influenza vaccination status, regular aspirin use, demographic factors, and hormone replacement therapy (HRT) in women.

Control Variables

Age

Description of Actual Data Sample:
  • Initial N: 5,888 participants took place in the baseline exam. Only 3,342 were included in the data analysis; these were the participants who were disease-fee at baseline and included 2,043 women and 1,299 men. The second cohort included 687 men and women (gender breakdown was not provided).
  • Attrition (final N): All participants were accounted for: no attrition was reported
  • Age: 65 years of age and older. The majority of the participants (2,341) were between 65 and 74.
  • Ethnicity: Unspecified, except that the second cohort was described as African American
  • Other relevant demographics: Information on income level and education level was obtained but baseline information was not reported
  • Anthropometrics: Baseline information on height, weight, BMI, and waist circumference was obtained but not reported 
  • Location: Participants were from four areas of the country:
    • Forsyth County, North Carolina
    • Sacramento County, California
    • Washington County, Maryland
    • Allegheny County, Pennsylvania.

 

Summary of Results:

Key Findings

  • The risk of incident events increased with age and the event rates were higher in men then women. On the average, a majority of participants remained free of CVD, COPD, and cancer and remained alive.
  • A number of behavioral factors were associated with continued health in older adults, including high-intensity exercise, never having smoked (or quit smoking), higher educational status (in men) and higher incomes
  • Self-reported health was a strong predictor of future health
  • Use of HRT in women was not associated with remaining healthy
  • Regular use of aspirin was associated with a decreased risk of remaining healthy
  • Dietary factors were associated with remaining healthy, with a lower percentage of calories from fat and a higher percentage of calories from carbohydrate (women only) in those who remained healthy
  • Wine-drinking was associated with remaining healthy
  • CVD risk factors and subclinical markers of disease were related to continued health
  • Lower systolic BP and absence of a history of HTN were associated with remaining healthy in both men and women
  • Lower C-reactive protein and higher baseline HDL-cholesterol were significantly associated with remaining healthy for both men and women
  • The absence of diabetes was significantly related to remaining disease-free.

Proportion of Healthy Years During Follow-Up Associated with Behavioral Risk Factors

Variables Proportion of Health Years
 Associated with Variable
95% Confidence Interval
Age (five years) 0.79* (0.75, 0.82) 
Male gender 0.74* (0.66, 0.83) 
Waist (10cm) 0.94** (0.90, 0.98) 

Exercise intensity

 No exercise

 Low

 Medium

 High

 


1.00*

1.30*

1.37*

1.53*

º

Cigarette smoking

 Never

 Former

 Current

1.00*

0.75*

0.56*

º
Wine drinking 1.11  (0.99, 1.24) 
Regular aspirin use 0.82*  (0.73, 0.91) 
Income (>$25,000)  1.19**  (1.06, 1.33) 
Recent change in finances  0.78**  (0.66, 0.93) 

ºCI's were not clear on original article due to formatting issues. Unable to report

*P<0.001

**P<0.01

Behavioral Factors Associated with Remaining Health During Follow-Up

Variables Proportion of Health Years
 Associated with Variable
95% Confidence Interval
Age (five years) 0.82* (0.78, 0.86) 
Male gender 0.82* (0.72, 0.92) 
Waist (10cm) 1.01 (0.96, 1.06) 

Exercise intensity

 No exercise

 Low

 Medium

 High

 

1.00**

1.25**

1.34**

1.42** 


 


(1.03, 1.52)

(1.09, 1.64)

(1.09, 1.85)

Cigarette smoking

 Never

 Former

 Current



 1.00*

0.78*

0.66*

 



(0.69, 0.88)

(0.56, 0.78)

Wine drinking 1.04 (0.93, 1.17) 
Regular aspirin use 0.83** (0.75, 0.93)
Income (>$25,000)  1.08 (0.96, 1.22)
Recent change in finances  0.75** (0.63, 0.90)

*P=0.01

**P=0.001

 Risk Factors, and Subclinical Disease Measures  Associated with Remaining Healthy

Behavioral Factors Proportion of Healthy Years Associated with Variable 95% Confidence Interval

Diabetes status

Impaired fasting glucose

Diabetes

 

0.94*

0.71*

 

(0.80, 1.10)

(0.62, 0.82)

Ankle/arm BP ratio <0.9

0.73*  (0.62, 0.86) 
Diastolic BP (1 standard deviation) 0.92**  (0.87, 0.97) 
HDL (1 standard deviation) 1.07**  (1.01, 1.14) 

Standardized carotid wall thickness (1 standard deviation)

0.85*  (0.81, 0.90) 
Ln (CRP) mg/L 0.93**  (0.88, 0.98) 

*P=0.01

**P=0.001

Author Conclusion:

The authors conclude that the data suggest that specific behavioral factors and medical interventions are associated with continued health in later life. Remaining physically active, refraining from smoking, consuming moderate amounts of wine, and maintaining weight are important prevention strategies. Controlling cardiovascular risk factors (diabetes, HDL cholesterol, and blood pressure) are associated with maintenance of good health in older adults.

Funding Source:
Government: National Heart, Lung, and Blood Institute
University/Hospital: Wake Forest University, University of Washington, University of Vermont, Johns Hopkins University, University of Pittsburgh, University of California
Reviewer Comments:
  • It is unclear to this reviewer if any anthropometric or biochemical analysis were conducted at any follow-up contacts that were made every six months. It appears that conclusions about good health over time were obtained from self-reports and hospital records but not follow-up data obtained as part of the study. Changes in weight, BR, dietary habits, and exercise habits could affect the study outcomes and do not appear to be accounted for.
  • This reviewer is concerned that BMI and waist circumferences were not reported at baseline. If the study population was mostly normal or underweight, the results may have been skewed. It is not clear to this review if obesity was one of the risk factors that was controlled for, although it does state "after controlling for traditional risk factors".
  • Demographic information, including SES and education level, were not reported at baseline. This information could affect participant's health status. It is not clear if data were controlled for SES or education level.
  • For the second cohort, the average length of follow up was 3.5 years. That is not adequate time to assess changes in health status, especially in "young old".
  • This reviewer was unclear as to how the two cohorts were integrated for the reporting of results.
Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) N/A
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) N/A
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? No
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? No
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? No
  2.4. Were the subjects/patients a representative sample of the relevant population? ???
3. Were study groups comparable? ???
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? ???
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) N/A
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? ???
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? N/A
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? Yes
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) N/A
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? N/A
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
5. Was blinding used to prevent introduction of bias? Yes
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? N/A
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) Yes
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? Yes
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? N/A
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? ???
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? N/A
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? Yes
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? ???
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? N/A
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? N/A
  6.6. Were extra or unplanned treatments described? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? Yes
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
7. Were outcomes clearly defined and the measurements valid and reliable? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? No
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? Yes
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? N/A
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? ???
  8.6. Was clinical significance as well as statistical significance reported? Yes
  8.7. If negative findings, was a power calculation reported to address type 2 error? N/A
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes