EAL

PWM: Prescribed Diet Plan and Nutrition Education (2006)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To investigate the role of motivational methods and progressive exercise as means of increasing physical activity in children enrolled in a multidisciplinary pediatric weight management program.

Inclusion Criteria:

Not specified

Exclusion Criteria:

Evidence of cardiovascular disease, diabetes, or other chronic systemic disease.

Description of Study Protocol:

1 year repeated measure outcome clinical trial.

Subjects were assigned to three treatment groups according to severity of obesity: Phase I (30 weeks) for severely obese (>200% ideal body weight (IBW)); Phase II (20 weeks) for moderately obese (150% to 199% IBW); Phase III (10 weeks) for mildly obese (121% to 149% IBW). When goal weight attained (<120% IBW), subjects began Phase IV “maintenance” phase.

Routine evaluation by comprehensive medical history and physical exam.

Anthropometric measurements done at enrollment, 10 weeks, and 1 year. Physical activity measured at baseline and after 10-30 weeks.

Program is 4 phase, multidisciplinary intervention model entitled “Committed to Kids Pediatric Weight Management.” Clinical intervention used protein sparing modified fast (PSMF) diet (2g protein per kg IBW per day supplied by lean meat or fish; approximately 600-800 kcal/day; carbohydrate intake limited to maximum of 20-25g/day to induce ketosis; diets supplemented with fluid, minerals, vitamins), behavior modification, and progressive (gradually increasing in volume) exercise program of moderate intensity (45-55% volume of oxygen consumed at maximal exercise effort).

PSMF followed for 30 weeks by Phase I, 20 weeks by Phase II, 10 weeks by Phase III; followed by long-term reinforcement period 22-42 weeks of balanced calorie-deficit diet of 1200 kcal, exercise, nutrition education, and behavior modification.

Exercise program specific to level of obesity (severely obese had shorter beginning durations and frequencies); recommended exercises for moderately and severely obese were arm-specific and less weight bearing. Students chose type of aerobic activity from list provided in handbooks and videos.

Data Collection Summary:

Dependent

Weight (electronically calibrated scale); height (stadiometer);
IBW% (based on National Center for Health Statistics percentiles for height and weight);
BMI (calculated as weight in kg/height in meters squared); relative fat (%)
fat free mass (determined by formula of Slaughter et al) calculated by measurement of triceps and subscapular skinfolds (Harpenden calipers); physical activity level (self report scale); v
olume (frequency and duration) of activity each week (on exercise record cards).

Independent

Phase I, II or III.

Control Variables

None specified.

Statistical Analysis

ANOVA, Newman-Keuls test to compare differences in initial body weights, mean %IBW, percent fat, mean BMI.

Description of Actual Data Sample:

Original Sample: 73 children (33M, 40F) aged 7-17 years (mean age 11.8 years)

Withdrawals/Drop-Outs: 25 did not complete 1 year program

Final Sample: 69 (95%) completed initial phase of 10, 20 or 30 weeks; 48 (67%; 18M, 30F) completed 1 year program

Location: New Orleans, LA

Race/Ethnicity: not specified

SES: not specified

Summary of Results:

Dropouts not statistically different from overall group of patients except for male preponderance.

Initial body weights significantly decreased at 10 weeks from 64.5kg to 57.9kg in mildly obese, 78.2kg to 69.0kg in moderately obese, 105.7kg to 90.9kg in severely obese (p<.001).

Mean %IBW significantly decreased at 10 weeks from 172.0% to 145.9% and maintained at 52 weeks at 147.2% (p<.001).

Percent fat significantly decreased at 10 weeks from 43.1 ± 7.1% to 33.9 ± 7.1% and maintained at 52 weeks at 34.5 ± 6.2% (p<.0001).

Mean BMI decreased from 32.9 ± 7.1 to 28.4 ± 6.4 at 10 weeks and maintained at 52 weeks at 28.0 ± 5.4 (p<.001).

Among subjects completing 10-30 week program, significant increase in self-reported daily activity levels (p<.05).

Fat free mass did not change significantly.

Author Conclusion:

Exercise is important factor in treating childhood obesity.

Progressive exercise used in conjunction with nutrition and behavior modification provides successful motivational strategies. These strategies encourage increased physical activity patterns, adoption of regular structured exercise training, and loss of excess body fat.

Funding Source:

University/Hospital:

Louisiana State Medical School

Reviewer Comments:

Weaknesses: no control group, no demographic information

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?	Yes
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?	???
	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?	???
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)	Yes
	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.)	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?	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?		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?	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?	N/A
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	N/A
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	N/A
	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?	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?	N/A
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	N/A
	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?	N/A
	7.5.	Was the measurement of effect at an appropriate level of precision?	N/A
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	N/A
	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?	N/A
	8.2.	Were correct statistical tests used and assumptions of test not violated?	N/A
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	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)?	N/A
	8.6.	Was clinical significance as well as statistical significance reported?	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?		Yes
	9.1.	Is there a discussion of findings?	N/A
	9.2.	Are biases and study limitations identified and discussed?	N/A
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	N/A
	10.2.	Was the study free from apparent conflict of interest?	N/A