Family-based Counseling to Reduce Childhood Overweight (2006)
Mellin LM, Slinkard LA, Irwin CE. Adolescent obesity intervention: validation of the SHAPEDOWN program. J Am Diet Assoc 1987; 87:333-8.PubMed ID: 3819254
- To evaluate the effectiveness and transferability of the group application of the program.
- To confirm that participation in SHAPEDOWN would be associated with reduced relative weight, decreased frequency of obesity-related behavior, improved self-esteem and weight management knowledge, and less depression.
- To confirm that the positive outcomes would not be affected by site.
Nutritionists volunteered as group leaders, four selected and participated in training.
Test group subjects enrolled in group weight management program of 14 weekly sessions for test group subjects and two parent sessions utilizing SHAPEDOWN program materials. Each 90 minute session included voluntary weigh-in, group interaction and exercise period.
Fees for intervention consistent with each site’s normal charges for such services.
Control group subjects received no treatment initially but were informed they could enroll in the next program commencing in 6 months.
- relative weight,
- obesity-related behavior,
Questionnaires, height and weight measurements taken at baseline, 3 months and 15 months.
Relative weight determined by standard height and weight measurement; determined by dividing actual weight by expected weight (from nationally representative height and weight data).
Weight related behavior measured by Habit Inventory questionnaire.
Self esteem measured by Rosenberg’s Self-Esteem scale questionnaire.
Depression measured by Rosenberg’s Depressive Affect Scale questionnaire.
Weight management knowledge determined by SHAPEDOWN Knowledge Test.
treatment or no treatment.
paired t-test to analyze mean scores, site differences.
Original Sample: 66 subjects, randomly assigned to test group (n=37) or control group (n=29);
52F, 14M; ages 12-18 years.
Three test group participants excluded from analysis of dependent variables and one from analysis of selected variables and relative weight because of missing data
Drop out rate was 16%.
33 in treatment group, 29 in control group
Location: four sites in northern California – rural health department, rural nutrition private practice, suburban medical clinic, urban medical center outpatient clinic.
Race/Ethnicity: 88% Caucasian, 5 Hispanic subjects, 1 Asian subject, 2 Black subjects.
SES: “wide range of socioeconomic groups”
At 3 months and 15 months, test group demonstrated significant improvement in relative weight (p<.001 at 3 months, p<.01 at 15 months), weight-related behavior, self-esteem and weight management knowledge, and less depression; control group significantly improved in self-esteem only. At 6 months, both test and control group decreased mean relative weight significantly (p value not specified).
No significant differences among sites in changes in these variables.
Change in relative weight for test group was –9.9±14.9% and for control group was –0.10± 13.2%.
At month 15, weight change in test group compared with controls was –5.15 kg.
For all variables in test group, mean change in relative weight at 1 year follow up was negative.
Program participation was associated with significant improvement at post-treatment and 1 year follow-up in relative weight, weight-related behavior, depression, and knowledge of weight management concepts.
Both groups at 3 and 15 months showed significantly improved self esteem, though increase was greater in test group.
None of variables appears to contraindicate participation, though sample size limits confidence.
Overall, study supports the effectiveness and transferability of the group application of the SHAPEDOWN program for adolescents.
|Government:||US Dept. Health and Human Services|
Strengths: 16% drop out rate among lowest reported by non-school integrated treatments.
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?||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?||No|
|2.2.||Were criteria applied equally to all study groups?||Yes|
|2.3.||Were health, demographics, and other characteristics of subjects described?||N/A|
|2.4.||Were the subjects/patients a representative sample of the relevant population?||N/A|
|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?||No|
|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.)||No|
|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?||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?||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?||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)?||N/A|
|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?||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|