Pediatric Weight Management

PWM: Physical Activity and Inactivity (2006)

Citation:

Levine, M., Ringham, R., Kalarchian, M., Wisniewski, L., and Marcus, M. Is family-based behavioral weight control appropriate for severe pediatric obesity? Int J Eat Disord. 2001 Nov;30(3):318-28.

 
Study Design:
Non-Randomized Controlled Trial
Class:
C - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:
  1. To evaluate the feasibility and acceptability of a 10-12 session family-based intervention for children with severe obesity.
  2. To determine the effects of treatment on relevant psychosocial factors.
Inclusion Criteria:
Children between the ages of 8 and 12, heavier than 160% of ideal body weight for age, height and gender according to WHO charts.
Exclusion Criteria:
Children who endorsed current psychiatric symptomatology that was serious enough to warrant immediate treatment; those enrolled in weight control program.
Description of Study Protocol:

Three groups of families treated over 1.5 years.

Participants recruited through advertisements in local newspapers and letters to local pediatricians and family physicians. Children and parents signed consent forms; all children required to attend sessions with at least one parent/guardian.

All children participated in initial assessment session, completed self-report questionnaires about depression, anxiety, eating attitudes and behaviors. Parents completed demographic questionnaire.

Families participated in 10-12 session behavioral group intervention adapted from family-based behavioral treatment developed by Epstein et al (1988), with added additional focus on peer teasing using role-plays and problem solving techniques, emotional and sneak eating, reinforcement of self-monitoring noncontingent on nature of actual intake.

Each weekly session began with weigh-in and individualized review of progress (review of self-monitoring records, homework, self monitoring books for eating and exercise) for children and parents.

Initial lessons focused on Stoplight Diet; children instructed to monitor intake and given calorie goals (1200-1500 calories per day, based on initial body weight) and red food goals (progressively lowered over treatment course, also instructed to increase intake of green foods) each week. Children given exercise goals each week (including goals to decrease sedentary activity) and worked toward 30 mins activity 5 days per week.

Additional sessions covered stimulus control principles for eating and physical activity, portion size control, assertiveness about eating, emotions and eating, teasing, relapse prevention.

All participants engaged in physical activity at end of each session, usually group walk.

Follow-up meetings occurred between 4 and 13 months after final week of treatment (average 7.8 +/- 4.1 months after final session).

Statistical Analysis

Repeated measures ANOVA to test differences among pretreatment, posttreatment, and follow-up sessions on weight and psychosocial variables. Follow-up paired t tests to evaluate differences between any two specific time points.

Data Collection Summary:

Timing of Measurements

  • Weight measured at start of each treatment session and at follow-up;
  • parent height measured initially;
  • child height assessed at first treatment session and each follow-up meeting
  • CDI and STAIC completed at pretreatment, posttreatment, and at follow-up session
  • ChEAT completes at pretreatment visit and follow-up session.

Dependent Variables

  • Height and weight in street clothing without shoes (balance beam scale);
  • BMI (weight in kg/square of height in m);
  • %IBW based on age, height, gender (WHO charts, Jelliffe, 1966);
  • depressive symptomatology (Child Depression Inventory (CDI), Kovacs & Beck, 1977);
  • state and trait anxiety (State Trait Anxiety Inventory for Children (STAIC), Speilberger, 1973);
  • disordered eating (Children’s Eating Attitudes Test (ChEAT), Maloney, McGuire, Daniels, Specker, 1989)

Independent Variables

  • all three cohorts of families treated

Control Variables

  • None specified
Description of Actual Data Sample:

Original Sample: 24 families out of 27 initial families (89%) completed initial assessments and participated in treatment groups (children: 54.2% male, mean age 10.2 years).

Withdrawals/Drop-Outs: 8 of 24 (one third) did not complete treatment program; reasons included difficulty attending evening sessions, problems arranging child care, conflicts with other activities.

Attrition rates were 55%, 17% and 22% over the 3 consecutive cohorts of families.

Final Sample: 16 families (67%).

13 children completed psychosocial measures.

Location: Pittsburgh, PA

Race/Ethnicity: 25% African American

SES: 68.4% had household income under $50,000

Summary of Results:

Children who completed the program did not differ from those who did not in age, gender or weight at start of treatment (p>.05). Significantly more African American families dropped out of treatment (67% of African American vs 22% of white families) compared with white families (p=.05).

Children who completed the program lost significant amount of weight during treatment (from 80.7kg to 78.2kg; t=2.8, p=.01).

Children lost average of 2.5 +/- 3.5kg during treatment; similar declines in BMI (p=.003) and % overweight (p=.007). 

Weight loss not maintained over follow-up period. Children gained average of 8.6 +/- 5.2kg between end of treatment and follow up. BMI increased between posttreatment and follow-up (32.1 to 33.9; p=.002).

BMI did not change significantly from pretreatment through follow-up.

Self-report of depressive symptoms and state anxiety declined from pretreatment through follow-up (p=.03). Similar but not significant decrease in disordered eating attitudes between pretreatment and follow-up (p=.07).

Improvements in self-reported depression and anxiety maintained despite tendency to regain weight following end of treatment.

Author Conclusion:

Results suggest that 10-12 session family-based behavioral intervention is feasible and has modest, short-term effects on weight of children who participate.

Majority of children who completed program (14 of 16) lost weight, with overall loss ranging from 0.2 to 11.8kg (average amount lost 2.5kg, 11.2% overweight).

Weight maintenance, rather than loss, may be more attainable goal for severely overweight children in short-term treatment. Controlled clinical trials with long term follow-up are needed.

Despite only modest weight changes, family-based behavioral treatment was associated with improvements in children’s depressive and anxiety symptoms; beneficial effects of program on children’s mood and anxiety levels do not appear to relate to changes in weight.

Attrition rates of second and third treatment cohorts (17%, 22%) more accurately reflect attrition from treatment for severe pediatric obesity.

Differential attrition rate for African American families suggests need for specific strategies for minority populations.

Early engagement and retention strategies appear to be critical for long term success of weight control programs.

The short term intervention was successful in limiting weight gain for most children and treatment had positive effects on psychosocial status; series of treatment strategies with family based behavioral weight control at its core may be the most effective way to address severe childhood obesity.

Funding Source:
University/Hospital: University of Pittsburgh Medical Center
Reviewer Comments:

Strength:

  • first data on use of family-based behavioral program with severely overweight children

Weaknesses:

  • no controls;
  • no intent to treat analysis;
  • high number of dropouts.
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
  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
  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
  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
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
  1. Was the research question clearly stated? Yes
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.1. 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
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
  1.3. Were the target population and setting specified? Yes
  2. Was the selection of study subjects/patients free from bias? 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
  2.1. 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
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? 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? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
  3. Were study groups comparable? N/A
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
  3.1. 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
  3.2. 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
  3.3. 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
  3.4. 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
  3.5. 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
  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. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? 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
  4.2. 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
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? 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
  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. 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? N/A
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? N/A
  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.) N/A
  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.) N/A
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  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
  5.4. 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
  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. 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
  6.1. 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
  6.2. 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
  6.3. 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? 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
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? N/A
  6.6. Were extra or unplanned treatments 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
  6.7. 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
  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. Were outcomes clearly defined and the measurements valid and reliable? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? ???
  7.1. Were primary and secondary endpoints described and relevant to the question? ???
  7.2. Were nutrition measures appropriate to question and outcomes of concern? 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? ???
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? ???
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? 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
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? No
  7.6. Were other factors accounted for (measured) that could affect outcomes? No
  7.7. Were the measurements conducted consistently across groups? 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. 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
  8.1. 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
  8.2. 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
  8.3. 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
  8.4. 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)? No
  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
  8.6. 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
  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. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? 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. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes
  10.2. Was the study free from apparent conflict of interest? Yes