EAL

PWM: Individual Child Counseling (2006)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To evaluate the effect of family therapy on childhood obesity.

Inclusion Criteria:

Families of children 10-11 years who were screened for obesity at school. Obese = BMI > 23, cutoff representing mean +2.4 times the standard deviation of the screened population. Severe obesity = BMI > 30.

Exclusion Criteria:

none specified.

Description of Study Protocol:

Both treatment groups received comparable dietary counseling and medical checkups for a period of 14 – 18 months, while one of the groups also received family therapy.

Behavioral treatment is focused on the process of behavioral change and on giving direct advice to patients and their parents. Six general aspects are involved:

self-monitoring,
stimulus control,
reducing the rate of eating,
nutrition education,
cognitive restructuring
increased physical activity.

Conventional treatment consisted of dietary counseling by a dietitian and regular visits to an experienced pediatrician with an interest in weight problems. The diet prescribed contained 1500-1700 calories, and the families were also advised to reduce energy content of the fat in the food to 30%.

Family therapy group received the same dietary counseling, and they received medical check-ups by another pediatrician; in addition, the pediatrician and a psychologist offered six family therapy sessions spread over 1 year.

Data Collection Summary:

Dependent

BMI (measured height & weight);
Skinfold Thickness (triceps, subscapular & suprailiac skinfold);
Physical fitness (Bicycle ergometer).

Independent

family therapy,
conventional treatment & untreated control subjects – see study protocol above.

Control Variables

untreated controls were age-matched with the two treatment groups.

Statistical Analysis

Mann Whitney U test, Fisher’s Exact Test, Chi-squared test, ANOVA.

Description of Actual Data Sample:

Original Sample: 44 obese children divided into two treatment groups & 50 untreated control children.

Withdrawals/Drop-Outs: 4 dropped out of the family therapy group after one session & another 2 after 3 sessions (wt & ht of these children were obtained by the school nurse).

Final Sample: 20 children in the family therapy group, 19 children in the conventional treatment group & 48 in the control group.

Location: Lund, Switzerland

Race/Ethnicity: not specified.

SES: not specified.

Age: 10-11 y; Controls were age-matched with the two treatment groups

Summary of Results:

No pretreatment differences between groups in any of the above mentioned variables.

BMI

At end of treatment, family therapy group manifested a sig. smaller increase in BMI (expressed in % of the initial value) than convectional treatment group (0.66% vs 2.31%; P=0.042), & a reduction in subscapular skinfold thickness (-16.8% vs +6.8%; P=0.034).

At follow-up 1 year after the end of treatment, the mean BMI differed sig. between the family therapy and the untreated control groups (P=0.046), and there was a sig. smaller increase of BMI in the family therapy group than in the untreated control group (mean +5.1% vs +12.0%; P=0.022).

None of the differences between family therapy and conventional treatment groups, or between the convectional treatment & the untreated control groups were statistically significant.

At the 1-yr follow-up, Fisher’s Exact Test showed sig. fewer children with severe obesity in family therapy group than in the control group (5% vs 29%, P=0.024). The difference between the family therapy & conventional treatment groups did not reach stat sig. (P=0.08).

Skinfolds

No untreated control group was available for comparison of skinfold thickness & physical fitness data.

Sig. differences were found in % of change for the triceps, subscapular & suprailiac regions between family therapy & the conventional treatment groups (with greater decreases noted in the family therapy group).

Physical fitness

Physical fitness was measured before treatment & at 1-year follow-up. At the 1-yr follow-up the family therapy group manifested sig. better results.

Other

At 1-yr follow-up, ANOVA showed that gender & puberty status did not contribute to variation of BMI with treatment type as a third factor.

Author Conclusion:

Family therapy seems to be effective in preventing progression to severe obesity during adolescence if the treatment starts at 10 to 11 years of age.

Funding Source:

Industry:

Forenade Liv Mutual group Life Insurance Company

Other:

University/Hospital:

Malmo General Hospital, University of Lund (Sweden)

Not-for-profit

Foundation associated with industry:

Reviewer Comments:

Strengths

Children were randomly assigned to one of the two treatments groups, the family therapy group being larger to allow for the expected higher dropout rate in that group.

Study showed a significant improvement in obesity with family therapy controlled to no therapy.

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?	N/A
	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?	N/A
	2.4.	Were the subjects/patients a representative sample of the relevant population?	No
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?	???
	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")?	Yes
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?	Yes
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?	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?	???
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?	N/A
	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?	Yes
	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?	Yes
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?	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)?	Yes
	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?	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?	N/A