PWM: Individual Child Counseling (2006)
Children:
- 6-11 y of age, screened for obesity at school
- Weigh > 20% of recommended weight-for-height and weight-for-gender. % overweight = 100 x (actual weight - desirable weight), according to the National Center for Health Statistics growth charts
- No history of psychiatric disorders
- Living with both parents
Parents:
- Agreed to attend group sessions
- Completed 2 questionnaires--Social Demographic Questionnaire and Activity Health Questionnaire
- Agreed to undergo regular physical checkups
Primary reasons for exclusion included:
Children:
- Reluctance to undergo blood sampling
Parents:
- Denial of their child being obese or needing treatment
Recruitment
Families recruited through a public school system in a city in Israel. 160 grade school children were identified as being obese, 140 met the inclusion criteria, and 60 agreed to participate in the study.
Design
Pariticipating families randomly assigned to two groups matched for sex and age.
Experimental Group: Parent participation only.
The parents attended 14 hour-long support and educational group sessions led by a clinical dietitian. Couples met in groups of 15 per session. The first four sessions were held weekly, the next four biweekly, and the last six once every 6 weeks. During the last 7 months of the intervention, each seperate family had 5 15-minute sessions (the short sessions were primarily to maintain contact with the family and to get height and weight measurements).
Control Group: Child participation only.
Children met in group sessions (without parents) of 15 children per group. Group sessions were lead by a clinical dietitian. Each child was prescribed a diet providing 6.3 MJ/d. Thirtyhour- The first eight sessions were conducted weekly and the remainder biweekly for a total of 1 year.
Children received individual counseling sessions when they missed the group session, encountered difficulties in adhering to the implemented change, or asked for a change in his or her diet prescription.
Blinding used (if applicable)
none
Intervention (if applicable)
Experimental Group: Parents Only
The topics discussed in parent only sessions included:
Control Group: Child Only
The topics discussed in child only sessions included:
Data Collection Methods
Anthropometrics (child and both parents)--Height and weight were obtained using standardized protocols. Obtained at beginning and end of study. In addition, anthropometric measurements were obtained for children at 6 mo follow-up.
Obesity defined as: Child--->20% recommended weight-for-age, weight-for-height, weight-for sex according the National Center for Health Statistics growth charts; Parents-->20% recommended for height based on the Metropolitan Life Insurance Company charts.
Body frame (child and both parents): elbow breadth by calipers.
Biochemical measurements (child and both parents)--not described in article
Dietary--(family)--7 day food records validated by a 24-hour recall
Questionnaires (completed by parents)--Social Demographic Questionnaire and Activity Health Questionnaire. Completed at beginning and at end of study. Reliability and validity examined (exact data not provided)
Blinding used:
None
Statistical Analysis
Intergroup data were compared by chi-square tests, t tests, and analysis of covariance (ANCOVA).
Interactions between variables were analyzed by multivariate ANCOVA (MANCOVA). Pearson’s correlation coefficients were used to determine relations between the variables.
P values < 0.05 were considered statistically significant.
Timing of Measurements
Anthropometric measurements and biochemical analyses were performed at initial clinic visit, last clinic visit (at 1 year). Children were invited back 6 months after the last clinic visit for measurement.
Dependent
- Child weight--percentage of change
- Parent weight--percentage of change
- Attrition (drop out rate and
- Adherance to program
Independent
- Success of treatment
- Treatment group (experimental or control); agent of change
Control variables
- Children randomly chosen for both groups were gender and age matched
- Parents' socioeconomic status (SES)
- Parents' educational status
- Parents' occupation
- Parents' country of origin
Initial N: 60 Families, 30 experimental group, 30 control group.
Attrition (final N):
Experimental group: 29 (3% attrition)
Control group: 21 (30% attrition)
Age:
| Experimental Group (range) |
Control Group (range) | |
| Children | 8.9 ± 0.33 (6–11) | 9.2 ± 0.2 (6–11) |
| Mothers |
37.5 ± 1.0 (26–47) |
38.3 ± 0.8 (29–50) |
| Fathers |
41.2 ± 1.1 (32–56) |
40.3 ± 0.9 (29–53) |
Ethnicity: not specified
Other relevant demographics: Families in final sample were primarily middle class.
Anthropometrics: Authors report that there were no significant differences between groups on anthropometric measures, and no important social differences between groups.
Location: Rehovot, Israel
Experimental group: 18 girls and 12 boys
Control group: 19 girls and 11 boys
Ethnicity: No ethnicity breakdown was provided
The results of the study are summarized in the following table.
|
Family Member |
Experimental Group percent excess weight lost (significance) |
Control group percent excess weight lost (significance) |
Statistical Significance of Group Difference |
|
Children |
-14.6% excess weight (p<.001) 79% lost >10% of excess weight |
-8.1% excess weight (p<.01) 38% lost >10% of excess weight |
Differences in amount of excess weight lost between groups was significant (p<.03) |
|
Mothers |
no significant difference |
no significant difference |
no significant difference |
|
Fathers |
-4.4% excess weight (p<.05) |
no significant difference |
Differences in amount of excess weight lost between groups was significant (p<.05) |
Children
Both the experimental and control groups lost a significant amount of weight from baseline to the end of treatment. However, the experimental group lost significantly more weight.
While 79% of children in the experimental group lost >10% of their excess body weight, only 38% of children in the control group did so. Additionally, in the experimental group 35% of children reached non-obese status (i.e., <10% overweight), while only 14% of children in the control group did so.
At 6 months following treatment the experimental group maintained 85% of their weight loss while only 40% of the control group maintained their weight loss.
Parents
Mothers in neither group lost a significant amount of weight. However, fathers in the experimental group lost a significant amount of weight (4.4% of their excess weight), while fathers in the control group did not lose a significant amount of excess weight.
Attrition
The experimental group had far fewer dropouts than the control group (3% versus 30%).
According to the authors, "Six of the nine children in the control group who left the study did so at their parents initiative. (The parents claimed that the program had been causing too much frustration and tension; two children were caught stealing sweets from the supermarket.) The other three children left the study at their own initiative; they could not control their snacking and they felt stressed and irritated."
"Treatment of childhood obesity with a family-based approach in which the parents are the sole agents of change has several advantages over the conventional approach in which children are the agents of change:
-
a lower dropout rate,
-
increased weight loss,
-
and better maintenance of weight loss in the children;
-
potential weight loss in the parents;
-
cost effectiveness;
-
and possible avoidance of some of the adverse effects of dieting.
This method may be easily integrated in educational as well as health care systems."
| University/Hospital: | University of Tel Aviv, Geha Psychiatric Hospital, Rabin Medical Center, Felsenstein Medical Center |
Strengths
- randomized design
Weaknesses
- Conclusions by the authors included cost effectiveness, avoidance of adverse effects of dieting for which no data was presented.
- High attrition rate; the parents and children who stayed may be different from those who dropped out (may be more health conscious and motivated)
- Small sample sizes
- Questionable generalizability to other ethnic groups, sociodemographic groups and age groups (children and parents in this study were from a city in Israel, mostly middle-class and ages 6-11)
- Unknown diet, physical activity; did not give results
- Study not blinded
- A number of potentially important variables were not controlled for, e.g., physical activity that could have affected the outcome
- No limitations provided
- No figure showing the percentage of overweight mothers and percent weight loss; both Figure 3 and 4 are the same (showing results for fathers)
- In discussion, author mentioned the possibility of power struggles in households between the parents; ? affect results; needs further study
- Use of old growth charts for children (1979); there are newer charts (ex., CDC)
- Also Height and Weight tables for adults may be outdated (1984)
- Indicated reliability and validity were examined for the questionnaires filled out by the parents was "acceptable." What is "acceptable"
|
Quality Criteria Checklist: Primary Research
|
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| 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? | 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? | Yes | |
| 2.2. | Were criteria applied equally to all study groups? | Yes | |
| 2.3. | Were health, demographics, and other characteristics of subjects described? | No | |
| 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) | 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? | No | |
| 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? | No | |
| 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? | No | |
| 6.7. | Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? | No | |
| 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? | N/A | |
| 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? | No | |
| 7.5. | Was the measurement of effect at an appropriate level of precision? | ??? | |
| 7.6. | Were other factors accounted for (measured) that could affect outcomes? | No | |
| 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)? | No | |
| 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? | No | |
| 9. | Are conclusions supported by results with biases and limitations taken into consideration? | No | |
| 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 | |