EAL

PWM: Individual Child Counseling (2006)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To investigate the effects of a multidiscipliary body mass reduction program on body composition, muscle function, and motor performance in 50 obese teens.

Inclusion Criteria:

BMI>97th percentile for chronological age and gender (based on representative Italian population data)
No signs or symptoms of overt cardiovascular, respiratory or orthopaedic disease
Parental informed consent

Exclusion Criteria:

Not specified

Description of Study Protocol:

Recruitment

Not described

Design

Pre- post-test design. Single treatment group. 3 week inpatient program.

Blinding used

Not described. Presumably none.

Intervention

Multidisciplinary intervention:

Diet:

Balanced macronutrient calorie restricted diet (1400-1600 kcal per day): 21% protein, 53% carbohydrates, and 26% fat. Diet compliance evaluated daily by dietitian.

Nutrition Education:

Daily lectures by professional staff. Focus was on improving diet through increasing fruit and vegetable consumption and decreasing energy intake from fats. Sessions also included information on improving food consumption practices and the importance of physical activity.

Psychological Counseling:

Conducted by a clinical psychologist 2-3 times a week in individual or group sessions. Focus was on cognitive-behavioral strategies, e.g., stimulus control procedures,problem solving, stress management, development of healthy eating habits, assertiveness and social sills training, cognitive restructuring of negative maladaptive thoughts and relapse prevention training.

Family Participation:

"When possible" (approximately once a week) sessions were also held with parents (unclear whether in a group or in individual sessions), focusing on improving motivation in changing lifestyle and interpersonal communication.

Physical Activity:

5 training sessions per week under guide of a therapist. Sessions lasted 45-60 minutes, primarily aerobic activities of moderate intensity.

Statistical Analysis

Anova analyzing time effect controlling for gender and puberty stage (Tanner stage). Tukey post hoc test conducted if significant main effects or interactions were detected. Pearson correlation p<.05 considered statistically significant.

Data Collection Summary:

Timing of Measurements

Baseline and post-treatment (3 weeks)

Dependent Variables

BMI
Body composition (using bioelectrical impedance)
Anaerobic power (Stair climbing: time to cover 1.99 miles, subjects trained on using the equipment)
Vertical jump (5 vertical jumps with hands on hips. Height of jump measured using an electronic timer connected to an optical acquisitional system.)
Muscle strength (One repetition maximum measures on three isotonic machines: leg press, chest press, and vertical traction)

Independent Variables

Participation in the 3-week body mass reduction program.

Control Variables

Gender
Pubertal stage (Tanner stage)

Description of Actual Data Sample:

Initial N: 50 (24 boys, 26 girls)

Attrition (final N): no dropouts

Age: 14.6±1.7 years (mean±SD)

Ethnicity: Italian

Other relevant demographics:

Anthropometrics

Height was the only measure significantly different between boys and girls. Boys were taller.)

Height (m): 1.63±0.07 (boys: 1.66±0.07; girls: 1.60±0.06)

Body mass (kg): 98.1±18.4

Tanner Stage	Total	Boys	Girls
III	9	5	4
IV	14	10	4
V	27	9	18

Location: Piancavallo, Italy

Summary of Results:

Measures of Body Composition

Variables	Pre-treatment Mean±SD	Post-treatment Mean±SD	Statistical Significance Difference
BMI	36.7±5.4	34.9±5.2	p<.001
Fat Mass (kg)	41.7±11.6	38.5±	p<.001
Fat-free Mass (%)	57.8±5.3	59.1±5.1	p<.001

Measures of Strength and Fitness

Stair Climb

Stair climbing test (SCT) times significantly decreased (-3.9%, p<0.01)
SCT power significantly increased (8.2%, p<0.05)
Subjects in Tanner stage IV had higher SCT power than those in stage III (p<0.05)
Boys had higher SCT power than girls (p<0.01)

Vertical Jump

Vertical jump power significantly increased (8.9%m p<0.05)

Muscle Strength

Upper and lower limb strength significantly increased (legs: 24.7%; upper limbs: 24.7%; p<0.001)
Boys were significantly stronger than girls in the upper body strength (p<0.001)

Interactions

positive correlation between vertical jump power and SCT power (p=0.01)
positive correlation between vertical jump power and strength (p<0.01)
Initial power values inversely correlated to changes in SCT power (p<0.001) and jumping power (p<0.01). In other words, obese boys and girls with low power measures benefitted most from the program.

Author Conclusion:

The present study demonstrated significant improvements in body composition, muscle function and motor performance following a 3-week residential body mass reduction program involving physical activity, diet, nutritional education, and psychological support in obese boys and girl aged 12-17 years.

Funding Source:

University/Hospital:

Italian Institute for Auxology, University of Burgundy (Dijon France)

Reviewer Comments:

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)	???
	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)	???

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?	N/A
	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?		N/A
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	N/A
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	N/A
	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?		N/A
	4.1.	Were follow-up methods described and the same for all groups?	N/A
	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%.)	N/A
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	N/A
	4.4.	Were reasons for withdrawals similar across groups?	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
	5.1.	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?	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
	6.4.	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?	No
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	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?		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?	N/A
	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?	N/A
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)?	N/A
	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?	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