EAL

AWM: New Technology and Telenutrition (2013)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To develop a counseling method that would assist African American breast cancer survivors with weight loss maintenance.

Inclusion Criteria:

Females who had been diagnosed with stage I, II, or IIIA breast cancer within the last 10 years and who identified themselves as African American
BMI 30 to 45kg/m²
Completed chemotherapy or radiation therapy at least three months previous (with the exception of tamoxifen)
Between the ages of 18 and 70 years
Willing and able to follow diet and exercise recommendations
Having spiritual influences in their lives as determined from a spirituality index screening questionnaire
Not presently on a special diet for a medical condition or currently participating in a formal weight reduction program.

Exclusion Criteria:

A low score of three or more of the items on the spirituality screening index
Women with a recurrence, a second primary tumor or other history of malignant tumors.

Description of Study Protocol:

Recruitment

Direct solicitation of clinic patients by their providers
Presentations and mailings to an AA breast cancer support group
Community advertising through a local newspaper
Brochures placed in the Karmanos Cancer Institute breast care clinic.

Design

Randomized controlled trial (pilot study).

Blinding Used

Implied with measurements.

Intervention

Dietitian led counseling for weight loss maintenance
Spirituality and dietitian counseling for weight loss maintenance
Dietitian-led counseling was individualized and completed by telephone
Free Weight Watchers coupons were provided to all participants for 18 months.

Statistical Analysis

Wilcoxon matched pairs tests were used to assess pre- and post-intervention changes within a single group
Mann-Whitney test or Wilcoxon matched pairs test was used for comparing continuous variables between two study groups
Kruskal-Wallis test was used to compare continuous variables across three groups
Fisher's exact test was used to compare categorical variables across three groups
Spearman rank correlations were computed between select pairs of continuous variables.

Data Collection Summary:

Timing of Measurements

Measurements were made at baseline.
At subsequent visits (six,12 and 18 months) a health update questionnaire was administered to capture any changes.

Dependent Variables

Body weight was measured to the nearest quarter pound in light clothing without shoes using a health-o-meter professional beam scale
Height was measured without shoes while standing on a stadiometer
Hip and waist measures were obtained without restrictive garments to the nearest 0.1cm.

Independent Variables

RD-led counseling was provided to all subjects for 18 months and done in person at baseline, six- and 12-month visits with telephone contacts
Weight watchers coupons were provided for free weekly attendance throughout the study
Subjects asked to decrease fat to 20% to 25% of calories and to keep protein at 20% of calories
Subjects also asked to exercise at least 30 minutes most days each week (at least five days) using their preferred mode of exercise)
Subjects were instructed to take 10,000 steps a day and were provided pedometers for self-monitoring. They were also asked to keep a log of time spent on exercise.
Spiritual counseling was done by a counselor with a Master's degree in counseling psychology and a certificate in biblical counseling
Contacts with the counselor were by phone and scheduled weekly for three months, biweekly for the next three months and then monthly
Subjects were taught to use daily meditation, daily readings and recording of thoughts in a journal
Reflection journal was used to develop understanding between experiences and feelings and making sense of those feelings that can affects faith
Physical activity patterns were captured using Stanford seven-day physical activity recall
Spiritual well-being questionnaire was administered
Block food frequency questionnaire was administered at beginning and end of study
Log of all spiritual influences not related to study before assessment visits at six, 12, and 18 months.

Control Variables

Health status questionnaire captured demographic information, gynecological history, medical history and body weight at baseline
Cancer diagnosis and treatment information was obtained from oncologist notes.

Description of Actual Data Sample:

Initial N: 81 women contacted the study initially. 31 enrolled and 24 were randomized after six months
Attrition: 22 total (11 in the Dietitian only group and 11 in the Spirituality + Dietitian only group)
Age: 18 to 70 years
Ethnicity: African American
Anthropometrics: No significant differences between groups at baseline
Location: Wayne State University and greater Detroit area.

Summary of Results:

Key Findings

Weight loss in the study was modest, with a mean of 2% at baseline weight at six months (SD, 5.7; N=24) and weight loss from baseline to six months did not differ significantly by diet arm assignment being 2.5% in RD-only arm and 1.5% in the spirituality arm
The sub-scale of the well-being questionnaire indicated that the mean overall score at baseline for spirituality in this study (mean 40.0, SD, 5.9; N=31) and there was no significant difference in mean score by diet arm.

Other Findings

Mean CES-D scores improved in both study arms indicated by a lower score with a slightly greater improvement in the spirituality arm vs. the RD-only arm.

Author Conclusion:

The spirituality counseling framework may be further refined and useful for other health promotion studies with African American populations.

Funding Source:

Industry:

Weight Watchers Group

Food Company:

University/Hospital:

NCI Cancer Center Support Grant CA-22453

Other:

NCI-CAM grant 1R21 CA100720

Reviewer Comments:

Limitations of the study include the small sample size and very modest initial weight loss, which made examination of weight loss maintenance difficult. Another limitation is that the spirituality counseling was administered by telephone, which may be less effective than in person counseling.

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?	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?	No
	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?		No
	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)?	No
	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?	No
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