EAL

PWM: Individual Child Counseling (2006)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To test the hypothesis that treatments that are designed to target and reinforce habit change and weight loss in obese parents and children together will be superior over 10 years to treatments that focus on child habits and weight change independent of parent success or to a control treatment that targets and reinforces the family members for attendance only.
To assess whether treatment for childhood obesity during developmental periods when the child is growing will influence final height.

Inclusion Criteria:

Children >20% ideal weight for age, height, and sex (Jeliffe, WHO, 1966 for kids, Met Life tables, 1959 for adults); triceps skinfold >95^th percentile for children their age, with at least one obese parent. No history of psychiatric contact for children; both parents living at home; and a parent willing to attend treatment meetings with their child.

Exclusion Criteria:

See above.

Children were excluded if they had a history of psychiatirc problems.

Description of Study Protocol:

Families were randomized to one of three groups based on target for reinforcement for weight loss and behavior change:

child and parent target
child target
non-specific target [control] (reinforced families for attendance).

All families were provided 8 weekly treatment meetings & 6 additional monthly meetings over next 6 mos. All received same diet [traffic light diet], exercise [aerobic & stretching] and behavior management [contracting, self-monitoring, social reinforcement & modeling; contingency mgmt (groups 1 & 2 only)] training. Follow-up at 21, 60 (5 years) and 120 mos (10 years).

Compensation: $100 for both parent & child at 5 years; $100 for each at 10 years or $25 for self-report

Data Collection Summary:

Dependent

Percent overweight (ideal weights for parents based on sex & heights AND average weights for children based on age, sex, and height; in 4 cases, the only way to obtain the child measurements at follow-up was self-report – the self-reports were adjusted for potential overestimating of height & underestimation of weight.)

Independent

Randomization to one of 3 groups that were provided similar diet, exercise, and behavior management training but differed in the reinforcement for weight loss and behavior change.

Child & parent target: reinforced parent & child behavior change & weight loss.

Child target: reinforced child behavior change & weight loss.

Nonspecific target: reinforced families for attendance.

Variables controlled for

Age
Gender

Statistical Analysis

Analyses of covariance to assess changes in child and parent overweight over time, Tukey post hoc tests to compare means across groups, Pearson Product-Moment Correlation Coefficients to examine relationships between child and parent percent overweight changes and height.

Description of Actual Data Sample:

N: 55 of the 76 families enrolled initially in the study (72% retention; loss to follow-up:

Attrition:

Psychiatric problems (n=1 after tx, n=6 more at 10 y)
Death (n=1 at 10 y)
Unable to contact (n=8 at 5y, n=5 more at 10y)

Ethnicity: 53 families white (96%)

SES: Middle class

Location: Pittsburgh

Selection: Families were selected from a sample of 185 families who applied for entrance to study

Baseline characteristics: No difference in Table 1 (missing) characteristics at baseline.

Summary of Results:

Child’s Results

% Overweight

Children in the child & parent group showed significantly greater decreases in % overweight after 5-10 years (-11.2% and -7.5%, respectively) than children in the nonspecific control group (7.9% and 14.3%, respectively).

Children in the child group showed increases in % overweight after 5 and 10 years (2.7% and 4.5 %, respectively) that were midway between those for child and parent and nonspecific groups and yet not significantly different from either.

Weight Gain

Children in groups 2 and 3 were significantly heavier than children in group 1 (P<0.05) at the 10 year follow-up.

Height

No significant group or by group over time difference were noted in the heights of the children.

The child 10-year heights were similar across groups and similar to the heights of parents of the same sex.

Weight regulation had no effect on height in this program.

Parent’s Results

% Overweight

No significant loss at 21 mos

Returned to baseline at 5 years,

Increase at 10 y [+9.1%, +4.6%, +10.6% for groups 1, 2 & 3, respectively)

10 year Relationship between child & parent weight and Height

Overweight: Not Significant (r=.07, p>.05)
Height: Similar between child & parent of same gender (see paper for results); also no significant differences in height between groups.

Author Conclusion:

These results are the first evidence for the long-term treatment of childhood obesity from preadolescence through young adulthood, as evidenced by significant differences between treatment and control groups for family-based treated children after both 5 and 10 years.

Behavioral treatments that focus on changing eating, exercise, and behavioral skills are related to long-term success in treating obese children.

Funding Source:

Government:

National Institutes of Health

Reviewer Comments:

Strengths:

long period of follow-up

Weaknesses:

no intent to treat analysis;
limited generalizability (all intact, middle class, white families);
could not tell the number of children that were not overweight at end of study (due to missing figure?);
said ‘identical’ education, but some differences between 1, 2 vs. 3 (in terms of behavioral procedures),
subject compliance with training or meeting attendance not described;
length of meetings and follow-up not described in order that applicability to other populations could be easily done (in other publications?)

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