HD: Effectiveness of Nutrition Intervention Methods (2010)
Anderson-Loftin W, Barnett S, Bunn P, Sullivan P, Hussey J, Tavakoli A. Soul food light: Culturally competent diabetes education. Diabetes Educ. 2005 Jul-Aug; 31(4): 555-563.PubMed ID: 16100331
To test the effects of a culturally competent dietary self-management intervention on physiological outcomes and dietary behaviors for African Americans with type 2 diabetes in rural South Carolina.
- African American living in rural South Carolina (SC)
- Diagnosis of type 2 diabetes
- 18 years of age or older
- At least one of the modifiable indicators of high-risk diabetes
- AIC 8% or higher
- Cholesterol 200mg per dL or higher
- Triglycerides 200mg per dL or higher
- Low-density lipoprotein (LDL) cholesterol 100mg per dL or higher
- BMI 25kg/m2 or higher
- High-fat dietary patterns as defined by Food Habits Questionnaire (FHQ) score of 2.5 or higher.
Mental or physical limitations that would preclude participation in group activities and discussion.
- Referrals from rural SC primary care physicians at three practice sites, followed by telephone interview from a research assistant (RA)
- All participants received $15 for attendance, Soul Food Light sweatshirts, small token gifts and door prizes at each intervention or testing session and results of their laboratory tests.
- Participants randomly assigned to experimental or control groups by a computer-generated table of random numbers
- 48 to 49 participants were recruited every six months for a year to maintain small group size.
RA blinded to group assignment.
A culturally competent behavioral intervention targeting high-risk persons with diabetes utilizing:
- Educational classes in low-fat dietary strategies: Four weekly 1 1/2-hour classes focusing on planning, purchasing and preparing healthy low-fat meals and making healthy eating choices away from home
- Peer-professional group discussions:
- Four monthly one-hour discussion groups with a peer-professional that focused on group education and peer discussion
- Nurse case manager certified as a diabetes educator led group discussion and answered questions
- Follow-up by a nurse case manager: Weekly telephone follow-up used for additional educational support, early identification of complications, problem solving and help in making informed choices.
Received referrals to a local eight-hour traditional diabetes class.
- Multiple analysis of covariance (MANCOVA) used to evaluate effects of intervention from baseline to post-intervention
- Repeated measures analysis of covariance used to account for medications that changed over time.
Timing of Measurements
- Six months post-intervention.
- Physiological outcomes
- Hemoglobin A1C
- Dietary behaviors
- Assessed using the FHQ adapted for southern African Americans
- Total scale scores greater than 2.5 indicate high-fat good habits.
Culturally competent dietary self management behavioral intervention.
- Medical history
- Medications and treatment
- Diabetes education
- Initial N: 97 agreed to participate and were confirmed for eligibility; 49 in treatment group, 48 in control group
- Attrition (final N): 65 participants retained throughout study, 67% retention rate; 38 in treatment group, 27 control group
- Treatment group: 58.9 years mean age
- Control group: 55.7 years mean age
- Youngest 32 years, oldest 86 years.
- Ethnicity: African American from rural SC
- Other relevant demographics:
- Majority were women, unmarried, unemployed and in their late 50s
- Fewer than half had completed high school
- Mean A1C for entire sample: 7.8% (SD = 2.2)
- Majority were obese and reported high-fat food habits
- Half had elevated total cholesterol, LDL cholesterol and reported one or more other chronic disease
- Differences between groups at baseline:
- Duration of diabetes
- Treatment group: 10.4 years (SD = 7.9)
- Control group: 6.4 years (SD = 5.9)
- Retention in treatment group: 78% vs. retention in control group = 56%
- Duration of diabetes
- Location: Rural South Carolina.
|Variables||Treatment Group||Control Group|
|Measures and Confidence Intervals||Measures and Confidence Intervals|
|Body Mass Index|
|Six months post-intervention||35.58±8.0||36.32±8.5|
|Statistical significance of group difference||P=0.009|
|Food Habits Questionnaire|
|Six months post-intervention||
|Statistical significance of group difference||P=0.005|
- Men significantly increased in BMI by 2kg/m2 at six months compared to women at 0.16kg/mm2
- At six months, weight decreased a mean of 1.8kg for the treatment group and increased a mean 1.9kg for the control group
- Treatment group lowered high-fat dietary behaviors to a moderate level while the control group continued high-fat dietary behaviors
- Women lost 1.5 lbs while men gained 5.4 lbs; men gained weight even though they decreased their dietary fat behaviors significantly more than women did.
- The results of this study imply an 8% reduction in risks of diabetes complications and a 6% reduction in diabetes-related deaths
- Results suggest that programs like Soul Food Light can produce significant differences in weight and dietary behaviors in vulnerable African American populations.
|Government:||National Institute of Nursing Research|
- Unsure how N was found in Table 1, cannot reproduce percentage for control group
- 69% of participants attended at least half of the eight intervention sessions, mean attendance was 4.8 sessions. Analysis included all participants regardless of attendance.
- Numbers in text do not match numbers in Table 2
- Tables 1 and 2 describing results are unclear as to how numbers were produced; text and tables do not match up
- Low retention rate in study with more dropouts in the control group, no explanation or details given. Results should take this into consideration.
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?||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?||No|
|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?||No|
|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")?||???|
|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?||No|
|4.5.||If diagnostic test, was decision to perform reference test not dependent on results of test under study?||Yes|
|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?||Yes|
|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?||???|
|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?||Yes|
|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?||Yes|
|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?||N/A|
|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?||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?||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)?||Yes|
|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?||Yes|
|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|