Pediatric Weight Management

PWM: Prescribed Diet Plan and Nutrition Education (2006)

Citation:

Israel AC, Guile CA, Baker JE. An evaluation of enhanced self-regulation training in the treatment of childhood obesity. J Pediatr Psychol 1994; 19:737-49.

PubMed ID: 7830214
 
Study Design:
Randomized controlled trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:
  1. To examine the contribution of the inclusion of a multiple-component self-regulation intervention.
  2. To enhance and examine multiple aspects of child self-regulation components of an obesity treatment program to assess contribution to treatment effectiveness.
Inclusion Criteria:
Children age 8-13 years, at least 20% overweight according to weight for height, age, and gender norms (standards not specified), with at least one parent willing to attend sessions and cooperate with requirements, with medical clearance from a physician, with absence of any physical or psychological difficulties suggesting that the program would be an inappropriate intervention, and with informed consent of both parent and child to the treatment program and associated research
Exclusion Criteria:
None specified
Description of Study Protocol:

Four component model of self-regulation, including goal setting, self-monitoring, self-evaluation, and self-consequation as core of intervention.

Participants recruited through newspaper articles, letters to pediatricians and school nurses.

Families randomly assigned to one of two treatment conditions: standard treatment (ST) and enhanced child involvement (ECI).

Parents and children met in separate groups of 5-7 families for 8 weekly 90 minute sessions followed by 9 biweekly sessions for total of 26 weeks of treatment.

Treatment using discussions and homework assignments based on CAIR approach – Cue control, physical Activity, food Intake and Rewards. Treatment for ST condition emphasized parent responsibility; treatment for ECI focused more on children’s management of own weight loss efforts, including training in self-management skills.

Follow up assessments conducted at 1 year and 3 years following end of treatment.

Data Collection Summary:

Dependent

  • height, weight, triceps skinfold thickness measured on site on week 1 of treatment, week 26 and at 1 year follow up;
  • height and weight measurements at 3 year follow up obtained from pediatric or school records or on site;
  • Locus of Control Scale for Children and Self-Control Rating Scale to measure self regulation and self control.

Independent

Emphasis on parent responsibility or child involvement in self-regulation.

Control Variables

Baseline % overweight

Statistical Analysis

mixed model analysis of covariance (ANOVA)

Description of Actual Data Sample:

Original Sample: Thirty six families with overweight children between ages of 8 years 11 months and 13 years 0 months.

Withdrawals/Drop-Outs:

Two families did not meet criteria for participation (one child receiving pharmacological treatment, one father refused to complete questionnaires); 8 families beginning treatment failed to complete 26 weeks of treatment; 6 families completing treatment not available for follow-up at both 1 and 3 years post treatment.

Final Sample: 11 families in ST condition, 9 families in ECI condition.

Female/male not specified

Location: not specified

Race/Ethnicity: not specified

SES: not specified

Summary of Results:

Children in both conditions achieved significant reduction in percentage overweight and triceps skinfold during 6 month treatment period (p<.01).

Follow-up period of 3 years characterized by increases above post-treatment levels, but some suggestion in 3 year follow-up results and long term patterns of benefit of enhanced child involvement approach.

Author Conclusion:

Overall concluded that multifaceted behavioral treatment program was successful in producing weight loss in children, though success is short lived and yields only modest results.

During follow-up period, overall pattern of weight gain (not loss) observed, and only 3 children maintained nonobese status, indicating that initial success in treatment was short-lived.

Failure in present investigation to find uniform relationships between aspects of self-regulation and outcome may be due to measures employed to assess components of self regulation.

Assignment of greater responsibility to the child does not seem to have impaired treatment effectiveness.

Funding Source:
Government: National Institute for Child Health and Human Development
Reviewer Comments:

Weaknesses: small sample size

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? 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? ???
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) Yes
  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.) 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? 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? Yes
  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? 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)? Yes
  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? No
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