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MNT: Weight Management (2015)

Citation:

Richardson CR, Brown BB, Foley S, Dial KS, Lowery JC. Feasibility of adding enhanced pedometer feedback to nutritional counseling for weight loss. J Med Internet Res. 2005; 7 (5): e56.

PubMed ID: 16403720
 
Study Design:
Non-Randomized Controlled Trial
Class:
C - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:

The objective was to test the feasibility of adding tailored, computer-generated, step-count feedback to a face-to-face nutritional counseling weight-loss intervention.

Inclusion Criteria:
  • Adult veterans affairs patients who were referred by a VA physician for outpatient nutritional counseling
  • Ambulatory, sedentary
  • Overweight with BMI of 28 or greater
  • At high risk for cardiovascular disease, by having at least one of the following cardiovascular disease risk factors: 
    • Type 2 diabetes
    • Hypertension
    • Hypercholesterolemia
    • Obesity (BMI greater than 30)
    • Known coronary artery disease.
Exclusion Criteria:
  • Participants reporting chest pain, shortness of breath, lightheadedness while walking, who had been advised by a physician not to walk, or who were undergoing a cardiac work-up
  • Individuals who had been enrolled in another nutritional counseling program within the past 28 days
  • If they could not comfortably communicate in English
  • If they were not competent to give informed consent.
Description of Study Protocol:
  • Recruitment: 12 participants were recruited from September to December 2003, four from each of three Department of Veterans Affairs Medical Centers.
  • Design: Non-randomized clinical trial 
  • Blinding used: Not applicable 
  • Intervention
    • Participants attended one-on-one counseling sessions with a registered dietitian for four sessions over three weeks, for both diet and physical activity counseling 
    • At the initial one-hour session, each participant received an enhanced SportBrain First Step pedometer to record time-stamped, step count data
    • Participants wore the device daily throughout the intervention
    • At the three follow-up sessions, the dietitian uploaded the computer data, reviewed a Web-based graphical display of step-count feedback, and helped set new walking goals
    • Participants received $10 for each of the four visits attended.
  • Statistical Analysis
    • Study was not powered to be able to detect clinically significant weight loss or increase in average daily step counts
    • Means and standard deviations were used to estimate the time spent in both the step-count and nutritional counseling components of the intervention
    • Mean participant satisfaction and percentage of sessions attended were also calculated
    • For pre-post comparisons, paired T-tests were used, such as for weight loss and mean daily step counts for the first seven days of the intervention with the final seven days of the intervention
    • The counseling time difference between the second and fourth visits were compared
    • Participant comments in response to the open-ended questions about the intervention were tabulated and reviewed for common themes.
Data Collection Summary:

Timing of Measurements

Participant weight measured at every visit. Daily step count uploaded to the website during the final week of the intervention.

Dependent Variables

  • Participant satisfaction measured through brief satisfaction survey
  • Participant weight measured without shoes using a single clinical scale
  • Mean daily step count
  • Participant self-efficacy for adhering to a walking program as measured by participant response to a single question: "I am confident that I can reach my new step-count goals next week."

Independent Variables

  • Participants attended one-on-one counseling sessions with a registered dietitian for four sessions over three weeks, for both diet and physical activity counseling 
  • Participant adherence to the intervention measured through attendance at visits, self-report of number of study days the pedometer was worn and electronic step-count data indicating days that the pedometer was worn
  • Counseling time required to deliver the physical activity and nutritional counseling components of the intervention
  • Technical problems with uploading the pedometer data.
Description of Actual Data Sample:
  • Initial N: 12 participants, 11 males, one female
  • Attrition (final N): 12 participants
  • Age: Mean 52.7 years
  • Ethnicity: Not described
  • Other relevant demographics: BMI averaged 37±6.5
  • Location: Three Veterans Affairs Medical Centers in the United States.
Summary of Results:

Other Findings

  • All 12 participants attended all four scheduled study visits
  • The average total time per face-to-face counseling session was 33 minutes
  • Initial mean weight was 255±49 lbs, and weight loss was 4.1 lbs over three weeks (P=0.004)
  • Weight loss ranged from -1.8 lbs to 9.7 lbs
  • Only one participant gained weight
  • Mean daily step counts during the first week averaged 6,019 steps per day, increasing to an average of 7,358 per day after the third week (average increase of 1,339 steps per day, or 0.6 miles, or 12 minutes of walking, N=10, P=0.04)
  • There was no significant change in self-efficacy between the first and final session.
Author Conclusion:

Enhanced pedometers with Web-based, step count feedback in conjunction with nutritional counseling is feasible and results in significant weight loss and increased walking among individuals at high risk for cardiovascular disease. Further research and randomized controlled trials with assessment of long-term outcomes are needed to test the impact of incorporating enhanced pedometer step-count feedback into routine medical care for high-risk individuals.

Funding Source:
University/Hospital: Health Services Research and Development Center for Practice Management and Outcomes Research, VA Medical Center, Ann Arbor, MI
Reviewer Comments:
  • Small number of subjects
  • Measurements not completed in all subjects
  • Short study duration
  • Authors note that they did not power this feasibility study to be able to detect clinically significant weight loss or increase in daily step counts.
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? ???
  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? ???
3. Were study groups comparable? N/A
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) N/A
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? N/A
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) N/A
  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? N/A
  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? ???
  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? ???
  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? N/A
  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? ???
  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? N/A
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)? 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