NC: Diabetes Management (2007)
- The purpose of the study was to evaluate longer-term effects of a Mediterranean lifestyle program
- The main hypothesis was that those participants in the MLP, compared to the usual care (UC) condition, would show greater 12- and 24-month improvements in targeted lifestyle behaviors, including eating patterns, physical activity, stress management and psycho-social variables, including perceived social support, problem-solving, self-efficacy and quality of life.
Women were recruited from primary care clinics with the following criteria:
- Having type 2 diabetes for at least six months
- Living independently
- Having a telephone
- Ability to read English
- Not being developmentally disabled
- Living within 30 miles of the intervention site (Eugene, OR, USA).
Women were excluded if:
- Older than 75 years of age
- Planning to move away from the area within the study's time span.
- A total of 279 post-menopausal women with type 2 diabetes, who were patients of participating primary care clinics, were recruited for the study
- All patients that met inclusion criteria were sent letters from their primary care providers, followed by phone calls inviting them to participate
- 51% of eligibile women contacted agreed to participate in the study.
- The basis of the MLP program combined Social Cognitive Theory, Goal Systems and Social Ecological Theory
- This model included social support.
- The MLP was delivered by an RD, an exercise physiologist, a stress management instructor and a combination of professional and lay support group leaders
- The program started with a 2.5-day non-residential retreat, which was followed by four-hour weekly meetings consisting of topics of physical activity, stress management and support group
- The intervention was conducted in four sequential waves two months apart, with approximately 40 treatment condition and 30 control condition participants in each wave.
- One-way analyses of variance (ANOVA)
- Repeated-measures multi-variate analyses of covariance (MANCOVA)
- Follow-up univariate analyses of covariance (ANCOVA).
Timing of Measurements
Baseline, six, 12 and 24 months.
- Diet: FFQ (Food Frequency Questionnaire) and saturated fatty acids from plasma fatty acid profile
- Physical activity: The CHAMPS Activities Questionnaire for Older Adults scale and seven days with the Yamax DW-500 pedometer to record the number of steps taken daily were averaged for the four study time points
- Stress management: Self-monitoring form consisting of number of minutes of stretching, breathing or medication or visualization for each of seven days
- Social desirability: Balanced Inventory of Desirable Responding
- Social resources: The Brief Chronic Illness Resources Survey (CIRS)
- Problem-solving ability: The Diabetes Problem-Solving Interview
- Self-efficacy: Confidence in Overcoming Challenges to Self-Care and Sallis Self-Efficacy for Diet and Exercise Behavor instrument
- Depression: Center for Epidemiologic Studies Depression Scale (CES-D)
- Perceived stress: Perceived Stress Scale
- Quality of life: The Diabetes Distress Scale (DDS).
Mediterranean Lifestyle Program (MLP), which consisted of healthful eating, physical activity, stress management, smoking sensation and social support.
Usual care in primary care practice.
- Initial N
- Usual Care: 116
- MLP: 163.
- Attrition (final N): 237 (85%)
- Usual Care: 60.7
- MLP: 61.1.
- Ethnicity: Primarily Caucasian
- Other relevant demographics: Homogenous in income, education level, present living arrangement
- Anthropometrics: Similar in weight, BMI, age diagnosed with diabetes, years taking diabetic medications
- Location: Eugene, Oregon.
Statistical Significance of Group Difference
Diet (Percentage of Calories from Fat)
Physical Activity (kcal/kg/hour Moderate Activity)
Stress Management (Daily Practice Minutes)
|Flexibility (Sit-and -Reach Percentage Score)||12 months||32.2||28.6||Yes
|Social Support (UCLA Negative Summary Score)||12 months||
|Social Support (UCLA Positive Summary Score)||12 months||3.28||3.00||Yes
|Self Efficacy for Diet and Exercise||12 months||
|Quality of Problem-Solving||12 months||4.1||3.9||Yes
- From an RE-AIM perspective, the MLP produced strong Reach, Adoption, Effectiveness and Maintenance results
- The MLP produced enhancements rather than decrements in quality of life, an important finding with a program requiring a significant time committment.
- The MLP produced consistent and significantly greater long-term (12- and 24-month) improvements than the UC in all of the four CHD behavioral risk factors: Eating patterns, physical activity, perceived social support and stress management and in percentage calories ingested from saturated fat, frequency, duration and intensity of moderate-intensity exercise, flexibility and number of daily minutes they practiced stress-management techniques and problem-solving skills
- The authors stated the strengths of the program were that the sample of high-risk females were a general representation, that the sample was randomized, many measures were employed, intensive intervention, extended length of follow up and the ability to retain 85% of the participants
- They also stated that because of a higher cost with the MLP, cost-conscious health care systems may not be interested in implementing this program.
|Government:||National Heart, Lung, and Blood Institute (ROI HL62156)|
- The authors demonstrated significant improvements in lifestyle and health outcomes with 12 to 24 months of MLP, as compared to usual care
- Many behavioral markers, as opposed to just clinical markers, were measured, such as stress management, quality of life, self-efficacy and social support, which may be better indicators of long-term health changes
- They did a thorough and organized discussion of their findings, strengths and limitations.
Quality Criteria Checklist: Primary Research
|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|
|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?||N/A|
|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)||Yes|
|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?||Yes|
|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?||???|
|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.)||???|
|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?||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?||Yes|
|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?||N/A|
|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)?||Yes|
|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?||N/A|
|10.2.||Was the study free from apparent conflict of interest?||Yes|