MNT: Effectiveness of MNT for Obesity (2009)
Holm RP, Taussig MT, Carlton E. Behavioral modification in a weight-reduction program. J Am Diet Assoc. 1983; 83(2): 170-174.PubMed ID: 6875145
This study confirmed the high prevalence of obesity in women of low socioeconomic status in the Medical Appointment Clinic at Grady Memorial Hospital, Atlanta.
None specifically mentioned.
None specifically mentioned.
All subjects were selected from the Medical Appointment Clinic at Grady Memorial Hospital. From February through December, 1979, house officers were informed about the formation of an obesity group-oriented behavioral modification program for any interested patient who could meet 1.5 hours per week for 12 weeks. During the 10-month period, 240 patients were referred. These were then each invited by mail to attend one of three groups, depending on the time of their referral.
Control participants were selected during the same 10-month period and matched to each behavioral modification group participant based on sex, race, age (±10 years) and percent ideal body weight (±25%).
Non-randomized clinical trial.
- Behavioral modification group-oriented weight reduction method was adapted for participants. Three separate behavioral modification programs were conducted by a physician and a registered dietitian to control group size. The sessions lasted approximately 1.5 hours each week.
- Behavioral modification focused on self-monitoring, environmental management, assertiveness training and exploration of alternative responses
- Controls received individualized counseling from a dietitian as the standard treatment for overweight outpatients.
No details provided on statistical analysis.
Timing of Measurements
- Over a four-day period in January, 1978, the charts of 660 clinic patients were surveyed for relative weights
- Over a two-day period in May, 1981, 337 clinic patients were surveyed to document who received financial assistance in making hospital or clinic payments
- Participants were weighed each week.
Weight measured with balance beam scale.
Behavioral modification vs. control group.
- Initial N: 80 participants and 80 controls, all women
- Attrition (final N): 80 completed the 12-week program. 31 matched pairs (62 individuals) had follow-up weights taken one year later. 74 participants were lost to follow-up for various reasons: They had moved, had become pregnant, would not return for a weight check, or were unreachable.
- Age: Mean age, 42.4 years
- Ethnicity: 148 African American women and 12 Caucasian women
- Anthropometrics: Groups were matched for age, sex, race and percent ideal body weight
- Location: Atlanta.
Short-term Weight Reduction for Three 12-Week Behavioral Programs
|Number Attending Two Sessions or More||Mean Weight Loss for Those Attending Two Sessions or More||Number Attending 10 Sessions or More||Mean Weight Loss for Those Attending 10 Sessions or More|
Behavioral 1 (N=25)
|22 (88%)||2.45 lbs||11 (44%)||5 lbs|
Behavioral 2 (N=22)
|Behavioral 3 (N=33)||29 (88%)||4.31 lbs||17 (52%)||7.7 lbs|
|Total (N=80)||70 (87%)||3.71 lbs||36 (45%)||6.5 lbs|
87% of the participants in the behavioral modification group attended two or more sessions, and 45% attended 10 or more sessions.
The mean weight loss for those attending 10 or more sessions was 6.5 lbs.
13% of the behavior modification group participants vs. 6.4% of the control participants maintained a loss of 20 pounds or more during the one year.
The mean weight loss for the behavioral modification group was 4.6% of their ideal body weight versus 0.9% for the control group.
The results of the behavioral modification program were statistically superior to those of the control program (P=0.058).
For the behavioral modification group, two persons directed 36 1.5-hour programs, resulting in 108 work hours.
For the control group, the dietitian spent 30 minutes on first-time patients and 15 minutes on their follow-up visits; therefore, approximately 60 hours were spent on 80 participants.
The control program required 55% as much time to care for 80 participants.
Overall, for participants whose mean weight was 241 pounds, it is difficult to conclude that a mean 5-pound weight loss represents a meaningful change or that this weight loss was due to behavioral modification. The results of this program among low socioeconomic status women, however, were comparable with the results of similar large, free-living programs among middle class participants.
|University/Hospital:||Grady Memorial Hospital|
Inclusion and exclusion criteria were not specifically mentioned. 61% dropout at one year; long-term results were not to be used in the evidence analysis.
Quality Criteria Checklist: Primary Research
|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|
|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?||No|
|2.2.||Were criteria applied equally to all study groups?||???|
|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?||Yes|
|3.1.||Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)||No|
|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?||???|
|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?||No|
|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?||No|
|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?||???|
|6.5.||Were co-interventions (e.g., ancillary treatments, other therapies) described?||N/A|
|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?||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?||???|
|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?||No|
|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?||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)?||???|
|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?||???|
|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?||No|
|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|