EAL

PWM: Individual Child Counseling (2006)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

Initially, a 12-month randomized intervention study was conducted. Of the 60 children and parents who were recruited for the initial program (children were randomly assigned to either the parent-only group-only--parents were targeted, or the child-only group--children were targeted), 50 were located and followed prospectively for 7 years.

The purpose of the follow-up was:

To report the long-term change in children's overweight following completion of a family-based, health-oriented approach for the treatment of childhood obesity, in which the parents served as the exclusive agents of change (experimental) compared with
a conventional approach, in which the children served as the primary agents of change (control).

Inclusion Criteria:

Children:

The child was overweight (>20% of the recommended weight-for-age, weight-for-height, and weight-for-sex)
Aged 14 to 19 years at 7-year-follow-up

Parents:

Agreed to attend group sessions
Agreed to undergo regular checkups
Provide written, informed consent

Exclusion Criteria:

Not discussed in this prospective, follow-up study.

Description of Study Protocol:

Recruitment

Originally, families were recruited from the public school system of Rehovot, Israel. 60 overweight children who met inclusion criteria agreed to participate in the initial study.

Blinding used (if applicable)-None

Intervention (if applicable)- For the initial 12-month intervention study, 60 children were randomly assigned to either the experimental or the control group. After termination of the initial program, 50 of the 60 children were located and followed up for 7 years. Both experimental and control groups were matched for age and sex.

Initial Study Protocol:

Experimental (family-based and parents-only)

Parents attended 14 hour-long support and educational group sessions led by a clinical dietitian. All suggested changes were intended for the entire family. The topics included:

limits of responsibilities
nutrition education
eating and activity behavior modification
decreasing stimulus exposure
parental modeling
problem solving
cognitive restructuring
coping with resistence

Parents were encouraged to practice authoratative parenting style.

Control (children-only; family environment not directly targeted)

Each child was prescribed a diet providing approximately 1,500 kcal/d.

Children participated in 30 1-hour-long group sessions led by a clinical dietitian. The topics included:

physicial activity
eating behavior modification
stimulus control
self-monitoring
nutrition education
problem solving
cognitive restructuring

Individual counseling by dietitian was provided if a child missed a group session, encountered difficulties adhering to change, or asked for change in his/her diet prescription.

Statistical Analysis --Repeated measures ANOVA to test differences in groups in percent overweight at different time periods. Chi-square used to compare groups in percent of youth who achieved nonobese status (<20% overweight).

P<0.05 was considered significant

Data Collection Summary:

Timing of Measurements--Weight and height were measured on children and parents at 1, 2, and 7 years follow-up using standardized techniques.

Dependent Variables

type of group child randomly assigned to: parent-only or child-only
follow-up points (end of intervention and 1, 2, and 7 years follow-up after intervention termination)

Independent Variables

percent weight loss change (children's)

Control Variables

children in both groups were age and sex matched

Description of Actual Data Sample:

Initial N: 60 children initially randomly recruited for this study

Attrition (final N): 50 at 7-year follow-up (5 lost to follow-up in both groups-- family-oriented parent-only or child-only)

Age: at 7-year follow-up: 14-19 years of age (16 + 0.5 years)

Ethnicity: not discussed

Other relevant demographics: number of males and females not presented

Location: Rehovot, Israel

Summary of Results:

At follow-up:

Percent overweight calculated as: 100 X (actual weight-desirable weight*/ desirable weight).

* Desirable weight for children based on 50th percentile weight for a particular age, sex, and height using U.S. National Center for Health Statistics data.

Weight loss determined by deducting the final percent overweight from the percentage overweight at baseline.

No significant difference in socioeconomic status (SES) were found between groups.

Children's Weight loss at Termination of Intervention and Follow-up Points:

At Termination of Intervention (12-month)

The children in the parent-only group achieved a significantly higher mean reduction in overweight compared with the children in the child-only group (14.6% vs. 8.4%; p<0.03).

35% of the children in the parents-only group reached a nonobese status compared with only 14% of the children in the child-only group (p<0.01)

Follow-up Points:

1-Year after termination of program: The mean weight loss in the children in the parent-only group was significantly different compared with the children in the child-only group (13.6% vs. 0%, p<0.05).

2-Years after termination of program: There was a 15% mean reduction in overweight in the children in the parent-only group compared to a mean increase of 2.9% in children in the child-only group (p<0.01).

7-Years after termination of program: Both children in the parent-only group and children in the child-only group demonstrated weight loss. However, the difference between the two groups was statistically significant (p<0.05). The children in the parent-only group had a mean reduction of 29% compared to 20.3% in children in the child-only group.

60% of the children in the parent-only group achieved nonobese status compared with only 31% of the children in the child-only group.

Over all follow-up times:

Mean reduction in percent overweight was greater at all follow-up points in children of the parent-only group compared with those in the children-only group (p<0.05).

Results from the repeated measure ANOVA indicated that boys' overweight was greater than the girls' and this trend continued at all follow-up times (p<0.007). However, the rate of overweight reduction did not differ between boys and girls.

Author Conclusion:

A family-based, health-centered approach that target solely parents was found to result in greater weight loss in obese children at all time periods--intevention termination, and at 1, 2, and 7-year follow-up visits.

Future studies should include comparision between parent-only and parent-child approaches, both targeting a health-centered approach rather than weight loss.

Studies need to be conducted to explore ways to enhance parent compliance and partnership in implementing the changes needed in the house, in accordance with the observation that some parents (particularly morbidly obese) were less cooperative, claiming that their personal freedom was threated.

In conclusion:

Parents should be the main change agent in weight-related interventions for their children, because their involvement is crucial to the induction of a healthy environment, parental modeling of healthy eating and physical activity, and improvement in the child's practices and weight status in the long term.

A health-centered, family-based approach rather than weight-centered approach may be the most appropriate intervention for the treatment and prevention of childhood obesity.

Funding Source:

University/Hospital:

Hebrew University of Jerusalem (Isreal), University of Minnesota

Reviewer Comments:

Weaknesses:

Unclear inclusion and exclusion criteria.
As reported in the initial article which described the methodology (including subjects) for the intervention program (Golan, Weizman et al., 1998) the treatment group lost one subject while the control group lost 9 subjects. The description in the follow-up study that each group lost 5 subjects is inconsistent with previous study.
Questionable generalizability
Lack of control for variables that might have affected results (ex., physical activity)
Modest sample sizes
Study not blinded

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
	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
	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
	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
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
	1.	Was the research question clearly stated?	No
1.	Was the research question clearly stated?		No
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	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?	No
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	No
	1.3.	Were the target population and setting specified?	No
	1.3.	Were the target population and setting specified?	No
	2.	Was the selection of study subjects/patients free from bias?	No
2.	Was the selection of study subjects/patients free from bias?		No
	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
	2.1.	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?	No
	2.2.	Were criteria applied equally to all study groups?	No
	2.3.	Were health, demographics, and other characteristics of subjects described?	No
	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?	No
	2.4.	Were the subjects/patients a representative sample of the relevant population?	No
	3.	Were study groups comparable?	No
3.	Were study groups comparable?		No
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	No
	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?	No
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	No
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	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?	No
	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
	3.5.	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
	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?	No
4.	Was method of handling withdrawals described?		No
	4.1.	Were follow-up methods described and the same for all groups?	No
	4.1.	Were follow-up methods described and the same for all groups?	No
	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%.)	No
	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%.)	No
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	No
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	No
	4.4.	Were reasons for withdrawals similar across groups?	No
	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
	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.	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
	5.1.	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
	5.2.	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
	5.3.	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
	5.4.	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
	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.	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?	No
	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
	6.2.	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
	6.3.	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?	No
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	No
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	No
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	No
	6.6.	Were extra or unplanned treatments 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
	6.7.	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
	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?	No
7.	Were outcomes clearly defined and the measurements valid and reliable?		No
	7.1.	Were primary and secondary endpoints described and relevant to the question?	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?	No
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	No
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	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?	No
	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?	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
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	No
	7.7.	Were the measurements conducted consistently across groups?	No
	7.7.	Were the measurements conducted consistently across groups?	No
	8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?	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
	8.1.	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
	8.2.	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
	8.3.	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
	8.4.	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)?	No
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	No
	8.6.	Was clinical significance as well as statistical significance reported?	No
	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
	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?	No
9.	Are conclusions supported by results with biases and limitations taken into consideration?		No
	9.1.	Is there a discussion of findings?	Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	No
	9.2.	Are biases and study limitations identified and discussed?	No
	10.	Is bias due to study's funding or sponsorship unlikely?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	No
	10.1.	Were sources of funding and investigators' affiliations described?	No
	10.2.	Was the study free from apparent conflict of interest?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes