EAL

MNT: Weight Management (2015)

Citation:

Welty FK, Nasca MM, Lew NS, Gregoire S, Ruan Y. Effect of onsite dietitian counseling on weight loss and lipid levels in an outpatient physician office. Am J Cardiol. 2007; 100(1): 73-75.

PubMed ID: 17599444

Study Design:

Time Study

Class:

C - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To examine the effect of an outpatient-based diet and exercise counseling program on weight loss and lipid levels with an onsite dietitian who sees patients at the same visit with the physician and is fully reimbursable.

Inclusion Criteria:

Overweight or obese patients
With one or more cardiovascular risk factors (86%) or coronary heart disease (14%).

Exclusion Criteria:

None specifically mentioned.

Description of Study Protocol:

Recruitment

Patients were seen at the initial visit with one provider, a preventive cardiologist and a dietitian at the Cardiovascular Health and Lipid Center at Beth Israel Deaconess Medical Center from 2000 to 2004. More than 90% had been referred by their primary care physician for management of hyperlipidemia and weight management. Remaining patients were self-referred.

Design

Time series study.

Intervention

Subjects were counseled to exercise 30 minutes a day and eat a modified Dietary Approaches to Stop Hypertension (DASH) diet (saturated fat less than 7%, polyunsaturated fat to 10%, monounsaturated fat to 18%, low in glycemic index and sodium and high in fiber, low-fat dairy products, fruits and vegetables). Caloric decrease was recommended when indicated.
The dietitian spent 45 to 60 minutes at the initial visit and 15 to 30 minutes at follow-up visits
Behavioral and exercise counseling was completed by the physician.

Data Collection Summary:

Timing of Measurements

Outcomes were measured at one concurrent follow-up visit with the dietitian and physician and more than one additional follow-up with the physician.

Dependent Variables

Weight, height, BMI
Lipid levels
Blood pressure.

Independent Variables

Exercise and DASH diet.

Description of Actual Data Sample:

Initial N: Assumed 80 subjects
Attrition (final N): 80 subjects
Age: Mean age 55±12 years
Other relevant demographics: Baseline BMI, 30.1±6.4
Location: Massachusetts.

Summary of Results:

Maximum weight lost was an average of 5.6% (10.8 lb) at a mean follow-up of 1.75 years.

64 (81%) of these patients maintained significant weight loss (mean 5.3%) at a mean follow-up of 2.6 years.

Average weight regain was only 0.3% of the maximum weight loss for most patients.

Weight regain for all 80 patients was 1.6% at an average follow-up of 2.6 years.

Average decrease in LDL-cholesterol was 9.3% (from 142±30 to 129.0±26mg per dL), average decrease in triglycerides was 34% (from 297±105 to 196±67mg per dL), and average increase in HDL-cholesterol was 9.6% (from 48±9 to 53±13mg per dL).

Systolic blood pressure was lowered from 129 to 126mm Hg (P=0.21) and diastolic blood pressure from 79 to 75mm Hg (P=0.003).

Author Conclusion:

In conclusion, having a dietitian counsel patients concurrently with a physician in the outpatient setting is effective in achieving and maintaining weight loss and is fully reimbursable.

Funding Source:

Reviewer Comments:

Initial N assumed to be 80 subjects. Physicians responsible for both behavioral and exercise counseling. Measurements of outcome variables and compliance with dietary intervention not described. Statistical analysis not described; many results reported without statistical significance. Authors note the strength of the study is the significant weight loss and its long-term maintenance, but no limitations.

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)	Yes

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?		N/A
	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?	N/A
	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?	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?		???
	4.1.	Were follow-up methods described and the same for all groups?	???
	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%.)	???
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	???
	4.4.	Were reasons for withdrawals similar across groups?	???
	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?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	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?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	Yes
	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?	N/A
	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?		???
	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?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	???
	7.5.	Was the measurement of effect at an appropriate level of precision?	???
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	Yes
	7.7.	Were the measurements conducted consistently across groups?	N/A
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		No
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	No
	8.2.	Were correct statistical tests used and assumptions of test not violated?	???
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	No
	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?	No
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