EAL

TN: Telenutrition Interventions by Registered Dietitians (2012)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To evaluate differences between rural older adults with diabetes reporting the presence or absence of food insecurity with respect to meal planning, preparation, shopping, obesity and glycemic control after receiving nutrition counseling through telemedicine.

Inclusion Criteria:

Subjects were Medicare beneficiaries with diabetes in federally designated, medically underserved rural areas of upstate New York
Subjects were participants from the Informatics for Diabetes Education and Telemedicine (IDEATel) project.

Exclusion Criteria:

None specifically mentioned.

Description of Study Protocol:

Recruitment

Subjects were participants from the Informatics for Diabetes Education and Telemedicine (IDEATel) project, and had been recruited via telephone contact from 189 rural IDEATel intervention participants residing in 14 rural counties of central and northern upstate New York.

Design

Descriptive study.

Intervention

Subjects had received diabetes self-management training by certified diabetes educators (both nurses and dietitians) using home telemedicine units for two to six years
Subjects had monthly video visits with a nurse diabetes educator and dietitian diabetes educator, such that there was a dietitian televisit every other month.

Statistical Analysis

Data are presented as mean ± standard deviation or number (percentage)
Group differences for continuous variables were measured by T-tests and categorical variables by Pearson chi-square tests
Categories of unknown, refusal and not applicable were excluded from all analyses.

Data Collection Summary:

Timing of Measurements

Data were collected between June 2006 and February 2007
Information concerning demographics, general health, food selection, food preparation, compliance with dietitian's advice and cooking/meal preparation activities was obtained annually.

Dependent Variables

Food insecurity assessed by the 12-item short form of the USDA Food and Nutrition Service Food Security/Hunger Core Module Survey, excluding questions about children
Questions about general health and cooking/meal preparation practices were selected from the Short Form Health Survey (SF-36) and the Comprehensive Assessment and Referral Evaluation Instrument
Additional categorization of subjects' attitudes and capabilities for meal planning and food selection was determined in part with questions from the Health Care Financing Administration/American Diabetes Association Diabetes Self-Care Activities module Diabetes Quality Improvement Project education variables
Supplementary questions related to food choices, following dietitian's advice and eating outside of the home were also asked by telephone.

Independent Variables

Telephone nutrition counseling as part of IDEATel project.

Control Variables

Subject personal and demographic questions were adapted from instruments used in the Hebrew Home for the Aged At Riverdale/United Hospital Fund community-based study of home healthcare and the Hebrew Home for the Aged At Riverdale/New York State Department of Health study of Adult Day Health Care.

Description of Actual Data Sample:

Initial N: 189 IDEATel subjects recruited via telephone contact
Attrition (final N): 74 participants included in the analysis
- 102 subjects did not answer the phone
- Six subjects had disconnected telephones
- Seven declined to participate due to hospitalization in a rehab facility (N=1), incapacitation due to cancer (N=1), deceased (N=2), had become aphasic (N=1) and declined to give a reason for refusal (N=2)
Age:
- 11% were aged 55 to 64 years
- 19% were aged 65 to 69 years
- 30% were aged 70 to 74 years
- 22% were aged 75 to 79 years
- 19% were aged 80 years or older
Ethnicity: 96% Caucasian
Other relevant demographics: 70% lived alone
Anthropometrics: Mean BMI was 31.6±6.5kg/m²
Location: Upstate New York.

Summary of Results:

Key Findings

Hemoglobin A1c was less than 7% in 47 (63%), 7.0% to 7.9% in 19 (26%), and more than 8% in eight (11%)
17 subjects (23%) were classified as having mild food insecurity, while none were classified as having severe food insecurity
30 subjects (41%) used a good assistance program such as Meals on Wheels or programs at senior centers during the previous year
Although reported food insufficiency was rare (N=71), 96% responded that they had enough food to eat, seven (10%) worried food would run out before they had enough money to buy more, six (8%) expressed that sometimes or often food purchased didn't last and they didn't have money to get more and 10 (14%) responded at least sometimes (N=8, 11%) or often (N=2, 3%) that they could not afford to eat balanced meals
Most purchased fresh produce (97%) and considered the dietitian's advice when purchasing food, 85% of the time
Dietitian's advice was the main reason for their food choice 45% of the time
Respondents stated that they understood how to make appropriate food choices (N=69, 93%) but only 38 (51%) reported that they followed the dietitian's advice five to seven days per week
Factors considered in making food choices were price (N=39, 53%), ease of preparation (N=41, 55%), access (N=33, 45%) and taste (N=60, 81%)
The most striking finding was the significantly higher rate of obesity among subjects classified with mild food insecurity
Participants reporting mild food insecurity (23%) had higher BMI (35.5±7.1kg/m² vs. 30.5±6.0kg/m², P=0.01) and lower household incomes (P=0.03) and were more likely to consider cost of ingredients in food preparation compared to food-secure participants (P=0.03)
The use of food assistance programs was similar between participants classified with mild food insecurity and food secure
Participants with mild food insecurity were more than twice as likely to consider cost of ingredients as those who were food secure, but both groups report similar adherence to dietitians' advice and had similar glycemic control.

Author Conclusion:

Strategies to address higher levels of obesity associated with food insecurity are needed.

Funding Source:

Government:

Cooperative Agreement 95C-90998 from CMS

Reviewer Comments:

Questionnaire not shown to be valid or reliable. Authors note the following study limitations:

Subjects were Medicare beneficiaries living in medically under-served areas participating in a telemedicine demonstration project and were primarily Caucasian, so the results of this study cannot be generalized to other rural populations with differing ages and ethnicities
Relatively small sample size, with approximately 40% of eligible subjects participating in the survey
Data concerning meal preparation and food choices were obtained by self-report, which has inherent limitations
There was no severe food insecurity.

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?		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?	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?	No
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?	Yes
	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.)	Yes
	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?	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?	???
	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?		N/A
	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.)	N/A
	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?	N/A
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	Yes
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	N/A
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	N/A
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	N/A
	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?		???
	7.1.	Were primary and secondary endpoints described and relevant to the question?	N/A
	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?	N/A
	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?	???
	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?	N/A
	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)?	N/A
	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