PWM: Prescribed Diet Plan and Nutrition Education (2006)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:

To attempt to determine if structured parental problem-solving training would facilitate child weight loss in a family-oriented weight reduction program.

Inclusion Criteria:

Obese children between ages of 6-12 years, at least 20% overweight for age, sex and height (Hamill 1979), free of medical conditions or medication that might influence body weight, not involved in other weight reduction programs, able to attend all sessions with a parent.

Exclusion Criteria:

None specified.

Description of Study Protocol:

Obese children were recruited through media announcements.

Children and parents attended one pretreatment session during which heights and weights were obtained and $35 deposit was collected. Deposit was refunded at final follow up session depending on number of sessions attended and assignments completed.

Children were ranked according to percentage overweight and assigned randomly from stratified blocks to three groups: behavioral, problem-solving, or instruction-only.

Each of parent/child groups met for 8 weekly 60 minute sessions, where games, stories, and activities were used to teach treatment objectives.

Children recorded food intake with parent assistance using color coded charts adapted from Epstein and Center for Science in the Public Interest. Foods categorized according to nutritional value using traffic light pattern (red, yellow, green signifying low, medium, high levels of desired consumption frequency); food intake recorded during 1st and 8th treatment weeks.

Children recorded physical activity with parent assistance using color coded charts that assigned points to different activities according to calorie expenditure required and time spent on exercises. Red, yellow, green denoted minimal, moderate, desired activity levels.

Children recorded activities during 1st and 8th treatment weeks; weekly totals summed and compared with designated weekly goals.

Treatment Groups

For behavioral group, group leader reviewed food intake and activity sheets (10 mins) and then presented behavioral weight reduction methods (20 mins). Children were weighed (10 mins) and parents exchanged recipes and exercise ideas (20 mins).

Methods presented through puppets, stories, games, etc. included self-monitoring, diet information, exercise information, stimulus control strategies, family support, cognitive restructuring, peer relations, and maintenance strategies.

For problem-solving group, first 40 mins identical to behavior group. Final 20 minutes devoted to problem solving exercises targeted towards problems associated with children’s weight control.

For instruction only group, participants were presented with same diet and exercise information as other two groups; also required to exercise for 15 minutes. Children then weighed (10 mins) and parents exchanged recipe and exercise ideas (20 mins). Subjects self monitored food consumption and exercise during 1st and 8th treatment weeks but this was not introduced as a behavior change strategy.

All groups attended 1 month, 2 month, 3 month and 6 month follow up sessions where weights were checked and progress reviewed.

Data Collection Summary:

Dependent

Means-end problem solving (among parents at sessions 1and 8 and at 3 month and 6 month follow up using written social problem solving test adapted from Shure, scored and tested for reliability); weight and height (taken with children wearing clothes but not shoes using balance beam scale, measured to nearest 0.25 in); percentage above average weight for age, sex and height; Quetelet’s BMI (Kleinbaum); food intake percentages (number of servings of each color category divided by total number of food servings per week); weekly physical activity percentages (from points assigned to different activities); parental expectations/perceptions/involvement (using seven point Likert scale).

Independent

Treatment including behavioral weight reduction methods, treatment including problem solving methods for parents, treatment with instruction only.

Control Variables

Pretreatment body weight, BMI, problem solving, food consumption, parental expectation, physical activity.

Statistical Analysis

One way ANOVA to examine pretreatment variables; multivariate analysis of variance (MANOVA) to assess differential weight changes and change in food consumption; repeated measures ANOVA to assess problem solving ability changes and physical activity changes; Student Newman-Keuls post hoc tests to examine variance; Pearson product-moment correlations to examine body weight change and mediating variables.

 

Description of Actual Data Sample:

Original Sample: 40 obese children and families.

Withdrawals/Drop-Outs: 1 family did not complete 8 week treatment program, 8 families did not participate in 6 month posttreatment follow up.

Final Sample: 39 families completed program (97.5%) and 31 completed 6 month follow-up (77.5%).

Location: Not specified.

Race/Ethnicity: Not specified.

SES: Not specified.

Summary of Results:

No statistically significant pretreatment differences between groups found.

Children in problem solving and behavioral groups decreased body weights, percentages overweight, and body mass indices significantly from pre to post treatment, whereas instruction only children did not.

Decreases in all three weight measures significantly greater for children in problem solving group than children in behavioral and instruction only groups.

Differences maintained for pretreatment to 3 and 6 months; from post treatment to 3 month follow up only the problem solving group demonstrated significant changes in percentage overweight and body mass index.

Parents in problem solving group significantly increased problem solving ability from pre to post treatment, whereas behavioral and instruction only parents did not. Significant changes from pretreatment to 3 and 6 month follow up existed only for parents in problem solving group; no significant changes from post treatment to follow up.

Children in both problem solving and behavioral groups increased consumption of green foods and decreased consumption of red foods significantly more than instruction only children.

No significant group or sessions effect on measure of physical activity.

Pre to post treatment change in body weight significantly negatively correlated with pre to post treatment change in parental problem solving ability. Posttreatment to 6 month follow up change in body weight significantly negatively correlated with posttreatment to 6 month follow up change in parental problem solving ability.

Significant correlations found between pretreatment to posttreatment weight change and change in consumption of red foods and green foods. Significant negative correlation found between change in body weight and changes in physical activity levels from pre to post treatment.

Author Conclusion:

Results support the addition of parental problem solving training to a behavioral weight loss program for obese children.

Children in problem solving group demonstrated greatest weight change at post treatment and 6 month follow up and parents achieved greatest improvement in problem solving ability. Change in parent problem solving ability significantly correlated with child weight loss at post treatment and at 6 month follow up.

Children in behavioral and problem solving group significantly increased intake of desirable low calorie foods and decreased intake of undesirable high calorie foods; weight change was correlated with these patterns.

Physical activity changes shows significant but unimpressive correlation with weight change; none of the groups demonstrated significant physical activity increases.

Superior weight losses of problem solving subjects may have resulted from children and their parents appropriately remediating individual problem areas.

Significantly greater weight losses exhibited by the problem solving children at post test were maintained during follow up period.

Problem solving strategy was significantly more effective than behavioral weight loss intervention, but did not fulfill all expectations (e.g. greater weight loss and improved physical activity level).

Funding Source:
Industry:
BRACCO Imaging SpA (Italy)
Other:
University/Hospital: villa Garda Hospital, Catholic University, San Giuseppe Hospital, Unviersity of Modena and Reggio emilia, University of Bologna (all Italy)
Reviewer Comments:

Weakness:

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? ???
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? ???
  1.3. Were the target population and setting specified? ???
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? No
  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? ???
  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.) ???
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? ???
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? ???
  4.4. Were reasons for withdrawals similar across groups? ???
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? ???
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? ???
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? ???
  5.5. In diagnostic study, were test results blinded to patient history and other test results? ???
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? ???
  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? ???
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? ???
  6.8. In diagnostic study, were details of test administration and replication sufficient? ???
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)? 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? ???
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