EAL

AWM: New Technology and Telenutrition (2013)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To assess if diet and lifestyle modifications would improve dietary compliance and quality of life for individuals with coronary heart disease.

Inclusion Criteria:

Males with established CHD
Postmenopausal females with established CHD.

Exclusion Criteria:

Subjects with diabetes
Uncontrolled angina or hypertension
Severe disease.

Description of Study Protocol:

Recruitment

From the greater Boston area

Design

Intervention

Eight-week dietary and lifestyle modification
Baseline three-day food diary analyzed by a dietitian
Three study visits to the Lipid and Heart Disease Prevention Program of New England Medical Center. Anthropometrics, fasting lipids, a health survey, quality of diet questionnaire and three-day food diary were obtained at each visit.
Baseline and weekly telephone calls from the dietitian. Each subject had personal calorie goals based on the Harris-Benedict equation.
Prepared meals and snacks were delivered to the subjects in coolers packed in dry ice
Rotating menus were dietitian-designed and met the guidelines for the National Education Cholesterol Program Step 2 diet
Vitamin and mineral fortification was within the tolerable upper intake level based on the Dietary Reference Intakes.

Statistical Analysis

Food records analyzed using Nutritionist 5 v.2.1.
Automated standardized enzymatic methods were used to measure lipid profiles
HDL cholesterol was measured after precipitation of other lipoproteins
LDL cholesterol was measured directly following immunoseparation using reagents and standards from the Genzyme Corporation
Cholesterol, triglyceride and HDL assays are standardized via the Centers for Disease Control
Between and within coefficients of variation for all assays are less than 10%
Student-Newman-Keuls test with statistical significance of P<0.05.

Data Collection Summary:

Timing of Measurements

Baseline three-day food diary analyzed by a dietitian
Three study visits to the Lipid and Heart Disease Prevention Program of New England Medical Center
Anthropometrics, fasting lipids, a health survey, quality of diet questionnaire and three-day food diary were obtained at each visit
Baseline and weekly telephone calls from the dietitian
Eight-week dietary and lifestyle modification.

Dependent Variables

Variable 1: Lipid profiles
Variable 2: Anthropometrics
Variable 3: Dietary intake.

Independent Variables

Home-delivered, heart-healthy meals.

Description of Actual Data Sample:

Initial N: 47
Attrition (final N): 35 (21 men, 14 women)
Age: mean age 62 years (40 to 79 years)
Ethnicity: Not described
Other relevant demographics: Not described
Anthropometrics: Mean body mass index 31.5kg/m²
Location: Greater Boston area, Massachusetts.

Summary of Results:

Between baseline and week eight, significant reductions were noted in dietary energy, total fat, protein, cholesterol, saturated fat, monounsaturated fat, polyunsaturated fat and sodium (P<0.05)
Between baseline and week eight, there was a significant increase in dietary carbohydrate and fiber (P<0.05)
Mean baseline BMI was 31.4 and went down to 30.2 at week eight
There were reductions (not significant) in weight, hip circumference and BMI from week four to week eight
Statistical improvement in mean fasting serum lipid profiles at week eight for total cholesterol and LDL cholesterol
Significant improvements (P<0.05) in diet quality of diet at week eight compared with baseline
For the quality of life questionnaire (scale of zero to 100), there was significant improvement from baseline to week eight with the following standard deviations:

Life Area	Baseline	Week 8
General health	65±19	71±19
Vitality	56±22	68±18
Physical function	79±19	84±15
Mental health	79±15	83±16

Author Conclusion:

Individuals who receive dietary and lifestyle education or counseling and are able to have their questions answered by a health professional show improvement in fat intake, lipid profile and body mass index.

Funding Source:

Industry:

Lifespring Nutrition, Inc.

Food Company:

Reviewer Comments:

The subjects in this study were given home-delivered meals, which may have made it easier to adhere to a heart-healthy diet. A longer study comparing the outcomes of healthful home-delivered and self-selected diets would be recommended. The regular contact from the dietitian, even if by telephone, seemed to increase subjects' knowledge of good food choices. However, 34 of the 35 subjects had previous nutrition education, so it may not be safe to assume that this study alone promoted changes.

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)	Yes
	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)	???

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?		Yes
	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?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	Yes
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	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?	N/A
	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%.)	Yes
	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?	N/A
	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?		N/A
	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?	N/A
	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?	???
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	Yes
	6.6.	Were extra or unplanned treatments described?	No
	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?	???
	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)?	No
	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