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NC: Maintenance of Health/Behavior Change Following Short-term CBT (2008)

Citation:

Miura J, Arai K, Tsukahara S, Ohno M, Ikeda Y. The long-term effectiveness of combined therapy by behavior modification and very low calorie diet: Two years follow-up. Int J Obes. 1989; 13 Suppl 2: 73-77.

PubMed ID: 2613431
 
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:

The purpose of this study was to evaluate the effect of combined therapy (VLCD and behavior modification) on long term weight maintenance during two years of observation.

Inclusion Criteria:

Refractory obese subjects.

Exclusion Criteria:

None noted.

Description of Study Protocol:
  • Recruitment: Not described
  • Design: 70 obese patients were assigned to one of three interventions
  • Blinding used: Not noted.

Intervention

  1. Very-low-calorie diet alone (VLCD; Optifast 70)
  2. Behavior modification alone
  3. Combined therapy by VLCD and behavior modification.

Statistical Analysis

  • Paired T-test
  • Data expressed as mean±SD.
Data Collection Summary:
  • Timing of measurements: Weight loss was measured at one month, four months and two years
  • Dependent variables: Weight loss.
Description of Actual Data Sample:
  • Initial N: 70 obese subjects
  • Attrition (final N): Not noted.
VLCD Behavior Modification Combined Therapy
N

15
M:F=6:9

39
M:F=12:27

16
M:F=6:10

Age 32.9± 9 36±14 37±14
IBW 158n±15% 137±16% 165±23%
  • Ethnicity: Not noted
  • Other relevant demographics: None noted
  • Location: Jikei University School of Medicine, Tokyo, Japan.
Summary of Results:

 

Variables

VLCD alone

Measures and confidence intervals

Behavior Modification

Measures and confidence intervals

Combined Therapy

Weight loss, One month

Mean, SD

7.5±2.1kg

Mean, SD

Mean, SD

8.3±2.3kg

Weight loss, Four months

 

4.5±2.3kg

 10.7±3.9

Mean weight loss, two years

Mean weight gain, two years

8.6kg

4.5kg

4.5kg

-1.3kg

 10.7kg

-1.3kg

Author Conclusion:

Weight reducing effect of combined therapy by behavior modification and VLCD was almost identical with that obtained by VLCD alone in a short term observation of a month. However, weight regain observed in the combined therapy group at 24 months follow-up was far less than that observed in the VLCD alone group. Therefore, the combined therapy of very-low-calorie diet and behavior modification was considered to be effective for the treatment of refractory obese patients.

Funding Source:
Reviewer Comments:
  • Statistical significance was not used in this study.
  • The subjects in the combined therapy group were older and weighed relatively more than the other two study groups.
  • This is an early study that looked at a specific VLCD product (Optifast) and specific behavior modification program (LEARN, University of Pennsylvania).
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? ???
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? No
  2.2. Were criteria applied equally to all study groups? ???
  2.3. Were health, demographics, and other characteristics of subjects described? ???
  2.4. Were the subjects/patients a representative sample of the relevant population? ???
3. Were study groups comparable? ???
  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? ???
  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? No
  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? ???
  4.1. Were follow-up methods described and the same for all groups? ???
  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%.) ???
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? ???
  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? ???
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? ???
  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.) ???
  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? No
  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? N/A
  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? ???
  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? N/A
  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? ???
  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? ???
  8.3. Were statistics reported with levels of significance and/or confidence intervals? No
  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)? ???
  8.6. Was clinical significance as well as statistical significance reported? No
  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