Pediatric Weight Management

Family-based Counseling to Reduce Childhood Overweight (2006)

Citation:

Eliakim A, Friedland O, Kowen G, Wolach B, Nemet D. Parental obesity and higher pre-intervention BMI reduce the likelihood of a multidisciplinary childhood obesity program to succeed--a clinical observation. J Pediatr Endocrinol Metab. 2004 Aug;17(8):1055-61.

PubMed ID: 15379415
 
Study Design:
Non-Randomized Controlled Trial
Class:
C - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:
  1. To assess the effects of a multidisciplinary pediatric weight loss program.
  2. To identify factors associated with successful weight loss.
Inclusion Criteria:
  • Children must be obese
  • aged 6-16 years
Exclusion Criteria:
No organic cause for his/her obesity and none received any medication which would interfere with growth or weight control (e.g., corticosteroids, thyroid hormones).
Description of Study Protocol:

 Six month extention of the 3 and 6 month results reported in Eliakim A, Kaven G, et al 2002 (for a total of 12 months)

Recruitment

Not described.

Design

Research design is described in Eliakim A, Kaven G, et al 2002. The multi-component design included dietary, physical activity, and behavioral interventions, and included family members in some aspects of the behavioral intervention (see Eliakim A, Kaven G, et al 2002 for details).

The last six months of the intervention was voluntary and differed from the first six-month intervention in that it focused primarily on exercise. The exercise program included:

  • group sessions twice a week for one hour
  • activities organized mostly as games and focused on endurance (with some attention to flexibility and coordination)
  • direction by professional youth coaches
  • encouragement for the participants to include another 30-45 minutes per week of walking or sport activity.

Diaries were used to track physical activity.

Obese children who were not able to participate in the multi-component program, but who were followed by the clinic served as controls (n=37).

In order to identify factors associated with weight loss success, treatment subjects were divided into quartiles based on the BMI percentile change. Subjects in the lowest quartile

Blinding used (if applicable)

Not described.

Statistical Analysis

Student's T used to compare baseline characteristics and responders versus non-responders to program interventions. ANOVA was used to compare changes in weight, BMI and BMI percentiles. Significance determed to be p<.05.

Data Collection Summary:

Timing of Measurements

Height, weight, and BMI were measured on a weekly basis. Results are presented for baseline, 3 months, 6 months, 12 months.

Dependent Variables

  • BMI
  • Weight 

Independent Variables

Participation vs. non-participation in the multi-component program.

Control Variables

  • Weight at baseline.
  • Parental weight.
Description of Actual Data Sample:

Initial N: 267 children began the 3 month program.

Attrition (final N): Continuing beyond the three month period for another three month intervention was optional. A final six month intervention (mainly exercise) was optional as well. 77 subjects finished the 12 month intervention.

Age: 6-16

Ethnicity: Not described.

Anthropometrics: Treatment and control groups were not significantly different on variables examined.

Location: Kfar Saba, Israel.

Summary of Results:

Comparison of 6-month and 12-month Outcomes

Variables

Treatment Group

Change from baseline (SEM)

Control group

Change from baseline (SEM)

Statistical Significance of Group Difference

Weight

6-Month

-1.1±0.5

2.9±0.3

P<.05

12-Month

1.2±0.6

6.5±0.6

P<.05

BMI

6-Month

-1.1±0.3

0.6±0.1

P<.05

12-Month

-1.3±0.3

1.4±0.3

P<.05

BMI Percentile

6-Month

-2.6±0.5

0.5±0.3

P<.05

12-Month

-4.7±0.8

0.5±0.7

P<.05

For treatment subjects over the 12-month period:

  • 43% lost weight
  • 70% had reduced BMI
  • 91% had reduced BMI percentile
  • BMI decreased (baseline to 12-months): 25.9±0.4 to 24.5±0.4 (p<.0005)
  • BMI percentile decreased (baseline to 12-months: 97.3±0.2 to 92.6±0.9 (p<.0005)

Other Findings: Responders versus Non-Responders

  • Non-responders were significantly (p<0.01) more obese at baseline than responders
  • Non-responders had a significantly (p<0.01) higher prevalence of family obesity
  • All non-responders had at least one obese parent, while 47% of responders had no obese parents

An interesting finding was that 12 of the 77 subjects who participated for the entire 12-month program gained weight at both 6 months and 12 months. The authors questioned the subjects and their parents about their continued participation despite lack of weight loss. The most common responses were that the participants enjoyed the physical activity sessions, and felt more fit. (Authors report that the participants who gained weight still improved their fitness--though no measures were provided in the article).

Author Conclusion:

Participation in the program was associated with a significant decrease in BMI over the 3-month treatment period, and this decrease in BMI was maintained over the 12-month period.

In contrast, children who did not participate in the program gained weight and increased BMI.

Funding Source:
University/Hospital: Tel Aviv University (Israel), University of California
Reviewer Comments:

Limitations:

  • No blinding
  • Many factors, such as ethnicity, SES, method of recruitment, etc. were not described.
  • Only 29% of the subjects who began the program continued until the 12-month period.

Strengths:

  • Concurrent controls
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? 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? 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
  2.2. Were criteria applied equally to all study groups? No
  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? 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) 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? 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? 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
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? 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
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? No
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? Yes
  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? 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? No
  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? ???
  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)? No
  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? No
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? No
  10.2. Was the study free from apparent conflict of interest? Yes