EAL

MNT: RDN in Medical Team (2015)

Citation:

Kellow, N. Evaluation of a rural community pharmacy-based waist management project: Bringing the program to the people. Aust J Prim Health. 2011; 17(1): 16-22. PubMed ID: 21616019

Study Design:

Before-After Study

Class:

D - Click here for explanation of classification scheme.

Quality Rating:

NEGATIVE: See Quality Criteria Checklist below.

Research Purpose:

To determine the effectiveness of a person-centered, multi-disciplinary healthy lifestyle pilot program based in rural pharmacies in Australia on body weight and health-related behaviors before and after implementation of the program .

Inclusion Criteria:

Adults aged 18 years to 50 years
Not currently accessing hospital-based health services
At least one risk factor for chronic disease development:
- Obesity
- Sedentary lifestyle
- Takes blood pressure (BP) or cholesterol-lowering medication
- Diagnosis of pre-diabetes/diabetes (DM)
- Family history of DM or cardiac disease
- Smokes
- Inadequate intake of fruits and vegetables
- More than one alcoholic drink per day for women, more than two for men.

Exclusion Criteria:

None stated.

Description of Study Protocol:

Recruitment

Advertisements in the local newspaper
Posters placed in general practitioners (GP) clinics
WMP information brochures in community pharmacies
Community pharmacists recruitment efforts
Referrals from local GPs and allied health professionals.

Design

Pre-experimental or before-and-after study
No comparison or control group.

Intervention

Nutrition-related:

Free individual nutritional assessment by a dietitian
Initial session with dietitian to explain WMP, collect baseline measures, establish one to three lifestyle changes clients wanted to make. Dietitian assessed readiness and motivation to make changes using motivational interviewing and solution-focused coaching. Action plans were established.
Monthly sessions with dietitian lasting 30 to 45 minutes. Behavioral goals were modified as needed, strategies to overcome barriers to change discussed and nutrition education and diet recommendations provided as requested by clients
Dietitian referred clients to pharmacist for medication review, to GP for tests and changes in medication needed, to an WMP health promotion officer if the client is interested in home garden set-up and maintenance and provided free gym voucher to meet with fitness instructor if interested in setting up a fitness program.

Statistical Analysis

Descriptive statistics used to summarize baseline demographic, anthropometric and clinical variables
Paired T-tests used to assess differences in variables pre-program and post-program.

Data Collection Summary:

Timing of Measurements

Program ran from March 2009 to February 2010, with staggered enrollment
Average time spent in program was 8.6±2.7 months
Range was more than 5.9 months to 11.3 months.

Dependent Variables

Body weight (kg) was measured using electronic calibrated scale and height (cm) was measured with a stadiometer
Waist circumference (cm) was measured by one observer using tape measure midway between lower rib and iliac crest
Dietary fruit and vegetable intake (servings per day) was determined from self-report dietary histories obtained by dietitian
Exercise was by self reported moderate-intensity, organized exercise (minutes per week)
Depression was measured from responses to the Hospital Anxiety and Depression Scale (HADS).

Independent Variables

Provided as requested by clients, and were not consistently provided across all participants.

Counseling provided by dietitian
Exercise program
Home gardening
GP visits
Medication review.

Description of Actual Data Sample:

Initial N: N=41 participant clients.
Attrition (final N): N=40 was reported. Not everyone completed all components of the program.
- 25 (62.5%) completed a four-month gym membership
- 20 (50%) participated in home vegetable gardening
- 17 (42.5%) attended at least one supermarket tour
- 13 (32.5) attended at lease one cooking class.
Age: 38.1±7.7 years
Other relevant demographics: Gender not reported
Anthropometrics: Baseline BMI of 33.5kg/m² (6.3kg/m²)
Location: South Gippsland, Australia.

Summary of Results:

Key Findings

A total of 19 (48%) WMP participants lost the initial goal of 5% body weight within nine months
Mean percentage weight loss was 4%
A total of 17 (43%) achieved 5% reduction in waist circumference within nine months
Mean percentage waist circumference loss was 3.9%.

	Mean (SD)	P-value
Dietitian visits	7.1 (3.5)	Not applicable
Body weight change (kg)	-3.8 (6.7)	<0.001
Waist circumference change (cm)	-3.9 (6.5)	<0.001
Fruit intake change (servings per day)	1.2 (0.2)	<0.001
Vegetable intake change (servings per day)	1.6 (1.0)	<0.001
Change in amount of exercise (minutes per week)	88.0 (47.7)
Change in HADS	Not applicable	P=0.75

Author Conclusion:

The pilot project demonstrated positive and significant improvements in body weight, waist circumference, fruit and vegetable intake and amount of exercise. Further research is needed to determine if health programs delivered in rural pharmacies are effective long-term and in other geographic locations.

Funding Source:

Government:

Rural Pharmacy Workforce Program -funded by Australian Government Department of Health and Ageing

Reviewer Comments:

Role of dietitian was supported and central to the study
Outcomes positive but many threats to validity
Selection bias evident
Lack of control group
Intervention not consistent for all participants
Time between measures not consistent for all participants
One site limits generalizability, especially without a control group for random assignment
One person taking measures
Not clear if parametric statistical tests should be used on certain variables with limited range (fruit and vegetable intake)
No control for other variables on outcomes
Full range of demographics not provided.

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)	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?	N/A
	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?	No
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?		No
	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%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	No
	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?		No
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	No
	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.)	No
	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?		No
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	No
	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?	No
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	???
	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?	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?		No
	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?	No
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	No
	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?	No
	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)?	No
	8.6.	Was clinical significance as well as statistical significance reported?	No
	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?		No
	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