TN: Telenutrition Interventions by Registered Dietitians (2012)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:

To examine:

  • The longer-term effects on behavioral, biologic and psychosocial outcomes at the 12-month follow-up (six months after the last face-to-face contact)
  • The implementation across multiple, diverse interventionists
  • The generalization of results across patients from the different clinics and interventionists participating in the study.
Inclusion Criteria:
  • Patients with type 2 diabetes
  • Living independently
  • Have a telephone
  • Not planning to move out of the area during the next year.
Exclusion Criteria:

Subjects with type 1 diabetes were excluded.

Description of Study Protocol:

Recruitment

Participants represented a broad cross-section of type 2 diabetes patients of primary care physicians at 12 medical offices located in one of six small- to moderate-sized communities within 30 miles of Eugene, Ore.

Design

Randomized 2x2 factorial trial. Participants were randomly assigned within providers to eliminate confounding of intervention and provider effects, but methods of randomization not noted.

Blinding used

Not applicable.

Intervention

All subjects received the basic intervention for the first six months: meetings at baseline (lasting 60 to 120 minutes), and meetings at three and six months with a health counselor at the Center for Healthy Living, at which tailored dietary goals were set with the aid of a multimedia touchscreen computer program. The computer program concluded with a tailored dietary fat reduction goal based on the participant's eating patterns and preferences and a one-page goals printout summarizing the information was provided. 

Basic intervention participants received no further intervention other than a general pamphlet about low-fat eating. Subjects were then randomly assigned to either the incremental effects of adding telephone follow-up or a community-resources utilization component.

  • Telephone follow-up only consisted of brief, structured calls to provide ongoing support and reinforcement for participants via continued contact with the same interventionist who met with the participant at the initial session. The protocol called for participants to receive seven gradually spaced follow-up calls prior to the final 12 months' assessment. Callers followed a flexible script for each session and calls lasted 15 to 20 minutes on average.
  • Telephone follow-up plus community support consisted of telephone follow-up as described above, a three-ring binder of indexed community resources (on eating out, grocery shopping, media, organizations), eight newsletters spaced over 12 months, and goal-setting at face-to-face meetings at baseline and at three- and six-month follow-up.

There were four interventionists: a nurse/CDE, RD, doctoral-level psychologist and an education major. All intervention staff were crossed with conditions, continued with a participant throughout the study and saw approximately an equal number of patients in each condition.

Statistical Analysis

  • Descriptive analyses using means, standard deviations, and distributions were used to clean the data, determine whether transformations were needed and describe overall level of improvement and implementation
  • Paired T-tests were used to evaluate overall change across conditions from baseline to the 12 months of follow-up assessments
  • MANCOVA was used to compare long-term results at the 12-month follow-up across conditions, intervention agents and office settings
  • Follow-up univariate ANCOVAs were conducted to reveal the source of effects only when the MANCOVA was significant for a given domain (behavioral, biological or psychosocial).
Data Collection Summary:

Timing of Measurements

Baseline and at six and 12 months.

Dependent Variables

  • Behavioral outcomes assessed through improvements on the validated Kristal Fat and Fiber Behavior Scale and the NCI Block fat screener
  • Biological outcomes evaluated by hemoglobin A1C and serum lipid profile, assessed through standard laboratory methods
  • Psychosocial outcomes included measures of quality-of-life, self-efficacy and community resources.
    • Quality-of-life assessed through Illness Intrusiveness scale
    • Self-efficacy assessed using four-item scale developed for the project
    • Use of community resources assessed by Chronic Illness Resources Survey.

Independent Variables

Assignment to:

  • Basic intervention
  • Telephone follow-up only
  • Telephone follow-up and community resources.

Control Variables

Baseline values.

Description of Actual Data Sample:

Initial N: 320 patients with type 2 diabetes were randomized; 56% female

Attrition (final N): 271 to 282 patients (84% to 93%) completed across conditions. Analyses of the dropouts vs. participants present at follow-up revealed no significant differences.

Age: Mean age, 59.7 years

Ethnicity: Approximately 90% white

Other relevant demographics: Had been diagnosed an average of 6.4 years

Anthropometrics: There were no differences between conditions on any of the demographic or medical characteristic variables collected

Location: Oregon.

 

Summary of Results:

Key Findings

  • Intervention components were implemented relatively consistently across conditions and across different interventionists. There were no differences across the intervention conditions or across the intervention staff on implementation rates.
  • There were few consistent differences between conditions, but results were robust across interventionists and clinics.
  • The T-tests to evaluate overall long-term improvement revealed consistent changes across the various outcomes: six of the seven T-tests showed significant improvement from baseline to the 12-month follow-up (P < 0.001).
  • Only the Illness Intrusiveness scale failed to show improvement.
  • All conditions showed comparable improvement.
  • The telephone follow-up component seemed to enhance long-term results on the lipid ratio (P < 0.02).
  • In contrast, the telephone follow-up component appeared to produce less improvement on the psychosocial measures and specifically on the Chronic Illness Resources Survey (P < 0.02) than conditions not receiving that component.
  • Additional analyses revealed no significant differences between interventionist and clinic; there were no significant main effects or interactions involving either interventionist or clinic on any of the MANCOVA analyses.
Author Conclusion:

The RE-AIM model is well-suited for evaluating the practical implications of the findings from this study. Our present results indicate that these interventions can be consistently implemented by staff from a variety of backgrounds and with patients from a variety of primary care practices. Thus, we conclude that the basic intervention seems to be applicable across a variety of primary care referral sites, patients and interventionists and most importantly, can produce lasting results at least six months after in-person intervention activities have concluded. Our findings also suggest that a brief, computer-assisted goal-setting intervention for dietary self-management may be a useful supplement to primary care.

Funding Source:
Government: National Institute of Diabetes Digestive and Kidney Diseases Grant R01-35524
Reviewer Comments:

Authors note the following strengths:

  • Randomized design
  • Reasonably large primary care sample
  • Investigation of possible interventionist effects
  • Multivariate analyses
  • Use of RE-AIM framework
  • Comprehensive set of outcome measures
  • Relatively low attrition rate.

Authors note the following limitations:

  • Absence of a significant proportion of minority participants
  • Relatively weak linkage to or involvement of the patients' primary care team.
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? Yes
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) ???
  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? ???
  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? 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? Yes
  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? Yes
  10.2. Was the study free from apparent conflict of interest? Yes