EAL

TN: Telenutrition Interventions by Registered Dietitians (2012)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

The purpose of this study was to evaluate whether an intervention of foods high in soluble fiber from psyllium or oats, plus a telephone-based, personalized behavior change support service, could improve lipid profiles and elicit cholesterol-managing lifestyle changes.

Inclusion Criteria:

Eligibility was determined at an initial screening visit
Potential participants with LDL-cholesterol at least 3.37mmol per L, but less than the 90th percentile for age and gender were screened into the study
Between the ages of 25 and 70 years
Participants provided written informed consent.

Exclusion Criteria:

Taking lipid-lowering medication
Receiving dietary treatment for hyperlipidemia
Having triglycerides (TG) over 4.5mmol per L; diabetes mellitus; uncontrolled high blood pressure; body mass index over 42; gastrointestinal disorders; present or past substance abuse; taking steroid medication; being pregnant or lactating; having any serious medical condition or abnormal lab value that precluded study participation.

Description of Study Protocol:

Recruitment

Newspaper, radio advertisements and flyers were distributed in the community to recruit subjects.

Design

Randomized controlled trial
A stratified randomization scheme was implemented to ensure that baseline LDL-cholesterol was balanced for the two treatment groups
Participants were stratified based on screening LDL values (3.37mmol to 3.12mmol per L or 4.14mmol per L), with pairs from each stratum randomly-assigned to the intervention or Usual Care (control) Group.

Blinding Used

Implied with measurements.

Intervention

Seven-week intervention that consisted of pre-packaged high-soluble-fiber foods, a personalized behavior change support service that included telephone conversations and supplemental mailings from a trained personal coach
The three personal coaches (a dietitian, a nurse and a counselor) received two weeks of targeted training in intervention protocols, data collection and documentation with support materials, daily assessment and a final assessment.

Statistical Analysis

A power analysis was performed to detect at least a 5% reduction in LDL-cholesterol with 80% power, alpha at 0.05 and an assumed dropout rate of 15%. Results suggested that a sample size of 150 participants divided between the two treatment groups would be adequate.
Statistical Assessment Software (SAS) procedure Proc Mixed was used with participants treated as a random effect
An a priori comparison tested if the amount of change experienced by the Intervention Group was significantly different from the amount of change experienced by the usual care group, alpha at 0.05.

Data Collection Summary:

Timing of Measurements

Participants were scheduled for clinic visits at baseline (Week Zero), Week Three and Week Seven
Each week, participants visited the study site to select their weekly supply of high-fiber-study foods. At these visits, participants met with the study coordinator to review their daily tracking sheet forms.
At each clinic visit, two sitting blood pressure measurements were obtained and averaged.

Dependent Variables

Serum lipids, measured using enzymatic assays, were used to determine total cholesterol (TC), high-density lipoprotein, cholesterol, TG, lipoprotein a, apolipoproteins A and B and glucose
Blood pressure.

Independent Variables

High-soluble-fiber food intake: Participants were instructed to consume four or more servings of high-soluble-fiber foods containing a psyllium or oats to achieve a total intake of six grams soluble fiber per day
Telephone-based, personalized behavior change support service: Personal coach provided telephone-based, individualized, interactive guidance and support to make lifestyle changes consistent with the NCEP's cholesterol-lowering guidelines. The three coaches were a dietitian, nurse and a counselor and they all received two weeks of targeted training in intervention protocols, data collection and documentation with support materials, daily assessments and a final assessment. All calls were recorded and randomly checked for quality assurance by trainers, project manager and an on-site manager. Weekly group phone calls were held with the trainer and project manager to discuss issues raised by the coaches and questions that arose from listening to tapes. The support service was based on documented best practices for successful behavior change, which included skill and confidence-building related to problem-solving and planning ahead, tracking goals and directed self-assessments.
24-hour dietary recall interviews from each participant for three randomly-selected days (two weekdays and one weekend day)
Validated food portion posters were used to estimate portion sizes
Dietary recalls were collected and analyzed using the Nutrition Data System for Research (NDS-R) software, version 4.0
A multiple-pass technique of 24-hour dietary recall was facilitated by the use of NDS-R, which contains an interactive interface
Three-day average intakes of energy and nutrients were calculated to estimate the baseline diet of each participant.
A validated questionnaire was used to assess physical activity at baseline and Week Seven clinic visit. Participants were asked how many times per week they engaged in strenuous, moderate and mild forms of exercise.

Control Variables

Gender
Age
Marital status
Education level
Employment
Income.

Description of Actual Data Sample:

Initial N: 150 individuals were initially screened into the study. 108 were randomized at Hershey Medical Center and 42 at the University Park Campus. Two individuals, one randomized to the Intervention and one to the Usual Care Group, did not return for clinic visits after the initial screening and were not included in the analysis.
Attrition (final N): 148 total: 32 men and 42 women in the Intervention Group and 34 men and 40 women made up the Usual Care Group
Age: 25 years to 70 years, with a mean age of 52±11 years
Ethnicity: Not described
Other relevant demographics: Not reported
Anthropometrics: No differences in age, sex, race or study end-points at baseline
Location: Pennsylvania State University.

Summary of Results:

Key Findings

In the Intervention Group, total cholesterol (TC) decreased 5.6%; low-density lipoprotein (LDL-C) cholesterol, 7.1%; low-to-high-density lipoprotein (HDL-C) cholesterol ratio, 5.6%; triglycerides (TG), 14.2% (P<0.0167)
Decreases in TC and LDL-C were significantly different from the Usual Care Group
In the Usual Care Group, TC decreased 1.9%; LDL-C, 1.2%; LDL-HDL-C ratio, 1.9%; TG, 4.4% (all not significant).

Other Findings

The Intervention Group also reported an increase in their knowledge, ability and confidence to make cholesterol-managing diet and exercise changes, compared with the Usual Care Group (P<0.05)
The Intervention Group had a greater decrease in energy intake from saturated fat (-1.6%) and increase in soluble fiber intake (7.3%) than the Usual Care Group (P<0.05)
The Intervention Group reported an increase in exercise vs. the Usual Care Group (P<0.05)
Both Intervention and Control Groups had a minimal reduction (less than 1%) in body weight, compared with baseline (P<0.0167).

Author Conclusion:

This study demonstrated the effectiveness of a seven-week intervention model that features both individualized, interactive support for behavior change and inclusion of select cholesterol-lowering foods
These results may have implications for dietitians in clinical practice, although it will be essential to test the long-term effectiveness of this approach.

Funding Source:

Government:

GCRC Grant M01 RR 10732

Industry:

Kellogg Company

Food Company:

University/Hospital:

Pennsylvania State University, Nutrition Department

Reviewer Comments:

A unique aspect of this study was the integration of behavior change theories and documented best practices into tailored, telephone-based support for lifestyle changes, while also providing high-soluble fiber foods
There was strong rationale for a telephone-based system in terms of efficacy and cost effectiveness in facilitating change.

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)	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?		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?	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?	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)?	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