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 describe and evaluate the effectiveness of one of these approaches: A brief tailored telephone-administered dietary intervention designed to increase soy food consumption among peri- and post-menopausal women who entirely self-select their diets.

Inclusion Criteria:

Provided written informed consent
Had no history of breast cancer
Eligible if peri- or post-menopausal and between the ages of 45 and 55
Have no contraindications to hormone therapy
Average at least two vasomotor symptoms per day during two weeks, with at least six moderate to severe symptoms
Had not used hormone therapy within three months of the trial
Had not used herbal supplements within one month of trial.

Exclusion Criteria:

No exclusions were made based on baseline soy intake.

Description of Study Protocol:

Recruitment: Study participants were women in two of the five arms of the HALT trial, recruited from May 2001 to August 2003 by mail
Design: Randomized double-blind placebo controlled trial
Blinding used: All study staff, other than the RD, were masked as to which patients were in the soy arm (N=79), to prevent bias in ascertainment of the outcomes

Intervention

Telephone counseling intervention
Five telephone contacts were made with a registered dietitian during a 12-month intervention, with the goal to increase soy food consumption to two servings daily.

Statistical Analysis

Analysis completed by SAS; P<0.05 was considered significant
Associations between estimates of isoflavone intake from the soy FFQ and serum concentrations, estimated using Spearman correlations stratified by treatment assignment and time-point
Percentage reporting any soy consumption and percentage achieving the diet intervention goals were compared by randomization using X² tests
Descriptive statistics were used to characterize study sample in the soy intervention vs. the placebo arm
Change from baseline was estimated using unadjusted models and linear regression models, controlling for baseline values of the dependent variables, body mass index and baseline energy intake, as measured by the FFQ.

Data Collection Summary:

Timing of Measurements

Measurements were made at baseline, three, six and 12 months.

Dependent Variables

Blood samples were collected in the morning after an overnight fast. Serum daidzein and genistein concentrations were measured using fluoroimmunoassay.
Weight was measured to the nearest 0.1kg with a beam balance
Height was measured by a stadiometer to the nearest 1mm
BMI was calculated as kg/m²
Physical activity measured by Women's Health Initiative physical activity questionnaire
Soy intake was estimated at each study visit, using a validated soy food frequency questionnaire
Diet was assessed at baseline, using a 122-item self-administered semi-quantitative FFQ. The RD tabulated the total number of soy servings by summing the amount estimated from the 19 foods on the soy FFQ.

Independent Variables

Telephone counseling intervention to increase soy consumption (subjects randomized to placebo or soy arm)
In the placebo arm, subjects were sent a Take 5 book, aimed at increasing consumption of fruits and vegetables and instructed to take four capsules daily. Subjects in this group were contacted by an RD once during the 12-month period.
In the soy arm, subjects were sent a letter introducing a 34-page diet intervention book, titled Soy Foods: A guide to eating soy. In addition to this, subjects were contacted by an RD trained in motivational interviewing. The RD contacted the subjects five times during the 12-month intervention and calls lasted between 30 and 45 minutes.
During the call, the RD asked women to estimate their intake of soy, using the book as a guide. This information was used to tailor the call to the woman's intake.

Description of Actual Data Sample:

Initial N: 351 women were randomized. The report described 163 women in two of the five arms.
Attrition: 163 women; 74 (94%) in the soy arm and 75 (89%) in the placebo arm
Age: Mean age in the soy arm was 52.4±2.5. Mean age in the placebo arm was 52±2.5.
Ethnicity: Primarily white (94% white in the soy arm and 90% white in the placebo arm)
Other relevant demographics: Not reported
Anthropometrics: Subjects were evenly divided between normal weight, overweight and obese
Location: Pacific Northwest.

Summary of Results:

Key Findings

Mean intakes of soy were similar for the soy and placebo arms at baseline (0.6±1.0 vs. 0.4±0.8 servings per day; P<0.05)
At the 12-month follow-up visit, the mean ± standard deviation servings of soy per day were 1.6±1.4 for soy intervention, compared to 0.5±0.9 within the placebo arm (P<0.001)
There were concomitant increases in serum isoflavones at three and six months, from baseline in the soy arm only, with approximate two-fold increases in both daidzein (mean, 66.4nmol per L; 95% confidence interval, 39.0 to 93.9) and genistein (mean, 100.4nmol per L; 95% confidence interval, 60.9 to 139.9) concentrations
Mean weight changed by over one kg during the 12-month period in each group and physical activity remained stable, suggesting that participants incorporated soy foods into their diet by substituting for non-soy foods, rather than adding them to their diet.

Author Conclusion:

In conclusion, this intervention, delivered via phone and written materials, increased soy consumption by one serving per day
Future directions should include incorporating voice technology to automate delivery and e-mail or internet, would which help in disseminating the intervention more widely.

Funding Source:

Government:

National Institute of Aging, National Center for Complementary and Alternative Medicine

Reviewer Comments:

The authors noted a major challenge was reaching subjects by phone, as less than 40% of the intervention participants received all five intervention calls by the RD.

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?	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.)	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)?	No
	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