Pediatric Weight Management

PWM: Individual Child Counseling (2006)

Citation:

Wadden, T., Stunkard, A., Rich, L., Rubin, C., Sweidel, G, McKinney, S. Obesity in black adolescent girls: a controlled clinical trial of treatment by diet, behavior modification, and parental support. Pediatrics. 1990, 85(3): 345-352.

PubMed ID: 2304788
 
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:
  1. To test the efficacy of a behavioral weight control program with urban, black adolescent girls from lower to lower-middle class families.
  2. To assess three different methods of involving mothers in the treatment of their daughters.
Inclusion Criteria:

Black girls from West and North Philadelphia between 12 and 16 years of age, from predominantly lower to lower-middle class families, who were at least 10kg overweight for their age, sex, and height, were free of medical conditions that would affect body weight, and had mothers who agreed to participate in the program with them, recruited by advertisements in community newspapers, school nurses in district 1, and attending physicians and residents at Children’s Hospital of Philadelphia.

Exclusion Criteria:
none specified
Description of Study Protocol:

Subjects attended an initial 1 hour interview with their mothers; mothers and daughters who wished to participate gave consent and deposited $35 (fee waived in cases of hardship).

Subjects attended 16 weekly, 1 hour treatment sessions and 6 monthly follow up sessions. Treatment was delivered in groups of 8-10 persons; sessions held Wednesdays after school and on Saturdays.

All subjects received same treatment with exception of parental involvement. Weekly sessions followed principles of Weight Reduction and Pride (WRAP) program designed specifically for these children. 100 page manual instructed children in measuring foods and beverages, recording food and calorie intake, consuming low fat, balanced meals of 1000-1500 kcal daily, understanding macronutrients, vitamins, and minerals, limiting consumption of high calorie snacks and fast foods, limiting times and places of eating, modifying self defeating thoughts concerning weight and food, and increasing physical activity.

Weekly lessons accompanied by homework assignment and quiz, children rewarded with stars that could be exchanged for prizes; subjects also received $1 for each session attended and 50 cents for each half pound lost.

Subjects weighed at monthly follow up visits, invited to discuss issues during group meetings. Therapists reviewed materials from previous treatment sessions.

Subjects stratified into three blocks on basis of BMI and randomly assigned to one of three conditions:

Child Alone (n=19): where girls attended all sessions alone and were encouraged to discuss the treatment materials with parents, who did not otherwise participate;

Mother-Child Together (n=14): where children and mothers attended all sessions together (4-5 children and mothers per group), mothers were given weekly reading materials and homework assignments, 16 week mother’s manual, and the option of losing weight and weighing in each week;

Mother-Child Separately (n=14): where mothers and children met concurrently in separate groups so both parties could freely express thoughts and feelings (children and mothers received treatment manuals described above).

Treatment sessions led by two clinical psychologists, each treating at least one group in each condition and one group of mothers from Mother-Child Separately condition.

Data Collection Summary:

Dependent

  • Weight (measured weekly on balance beam scale),
  • body composition (at baseline and week 14 by densitometry – submersion in 5x5x5.5 ft tank while seated in chair suspended from Chatillion 15kg scale with measurements repeated until three readings within 25 g obtained, residual volume determined by oxygen dilution technique),
  • body density (calculated from Brozek formula),
  • percentage of fat (calculated from Siri formula),
  • fat free mass (body weight minus fat weight),
  • kg of fat,
  • BMI,
  • serum total, LDL and HDl cholesterol concentrations, triglycerides,
  • blood pressure,
  • self esteem (Piers-Harris Self-Concept Scale),
  • depression (Children’s Depression Inventory).

Independent

Level of mother involvement (none, together, concurrent but separate).

Control Variables

none specified.

Statistical Analysis

Multivariate ANOVA to examine differences at baseline, ANOVA to assess treatment related changes in weight, fat, and other measures.

Description of Actual Data Sample:

Original Sample: 58 girls

Withdrawals/Drop-Outs: Attrition averaged 22% across conditions (10 of 46 children).

Final Sample: 47 enrolled in study; analysis performed on 36 who completed study (77% of those enrolled - 16 of 19 from Child Alone, 10 of 14 from Mother-Child Together, 10 of 14 from Mother-Child Separately). 28 of 36 ((78%) completed both baseline and end of treatment assessments of body composition; 31 of 36 (86%) participated in 6 month follow up.

Location: Philadelphia, PA

Race/Ethnicity: black

SES: predominantly lower to lower-middle class; 64% of girls from single parent households.

Summary of Results:

Weight Changes

At end of 16 weeks,

  • subjects in Child Alone lost 1.6 kg,
  • subjects in Mother-Child Together lost 3.7 kg and
  • subjects in Mother-Child Separately lost 3.1 kg;

Weight declined significantly, no significant differences among treatment conditions.

BMI

At end of treatment, mean BMI of 35.2 declined significantly to 33.9; no differential changes among treatment conditions.

87% of total sample achieved reduction in BMI, 37% achieved reduction of 5% or more.

13% of subjects increased relative weight; BMI did not increase by more than 5%.

Body Composition

Analysis of 28 subjects completing body composition assessments showed average weight loss of 1.7kg. Densitometry showed significant reduction in body fat from 37.1kg to 35.1 kg; thus all of weight loss was derived from fat, fat free mass increased by 0.3kg; no significant differences among treatment conditions in loss of fat.

Adherence

No significant difference in attendance among conditions (average 13.5 meetings attended) but the more meetings attended, the more weight was lost (r=.47, p<.005). Mothers averaged attendance at 9.3 meetings only.

When weight loss examined in relation to mothers attendance (no attendance - Child Alone subjects, poor attendance – less than 9 sessions, or good attendance – 9 or more sessions), daughters lost mean of 1.6, 1.9 and 4.9 kg, respectively, and differences were significant.

Total cholesterol concentration decreased significantly during treatment, with most attributable to reduction in LDL cholesterol. HDL declined; mean initial risk of CVD and mean triglyceride level did not change significantly.

No differential changes among treatment conditions for any of these variables.

Mean systolic and diastolic blood pressures remained within 1 mm Hg of baseline values; no differential changes among conditions.

Child Depression

Scores on Piers-Harris scale increased significantly during treatment from 57.6 to 59.9. Scores on Child Depression Inventory decreased significantly from 9.7 to 6.8.

Six Month Follow-up

31 children participated in 6 month follow up – subjects in Child Alone group exceeded pretreatment weight by 3.0kg, subjects in Mother Child Together group exceeded pretreatment weight by 1.7 kg, subjects in Mother Child Separately group exceeded pretreatment weight by 3.5 kg.

Height increased significantly from 163.2cm to 164.9cm at 6 months.

Mean BMI at 6months was 35.4, not significantly different from baseline 35.2. 54% subjects below baseline BMI at 6 months (11% showed reduction of 5% or more); 46% showed increase in BMI (21% showed increase of 5% or more).

Author Conclusion:

Multidisciplinary behavioral program produced significant weight losses in black female adolescents, which were associated with improvements in body composition, cholesterol concentration, and psychological status.

Mothers’ participation in treatment favorably influences daughters’ weight losses; form of mothers’ participation does not appear to matter. Daughters of mothers who regularly attended treatment sessions lost more than twice as much weight as did daughters of mothers with poor or no attendance.

Combination of modest caloric restriction and increased physical activity produced favorable changes in body composition; children even increased fat free mass while reducing body fat.

Only 54% of subjects less overweight at follow up than at the beginning of study; subjects returned to same degree of overweight at follow up with which they began the study.

Study would have benefited from inclusion of no treatment control to assess long term strengths and weaknesses of program.

Funding Source:
Government: NIMH, NICHD
Industry:
Sandoz Nutrition Company
Pharmaceutical/Dietary Supplement Company:
University/Hospital: University of Pennsylvania School of Medicine,, Rutgers University Medical College of Pennsylvania, Drexel Unviersity
Not-for-profit
0
Foundation associated with industry:
Reviewer Comments:

Limitation: no control group

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? ???
  2.2. Were criteria applied equally to all study groups? ???
  2.3. Were health, demographics, and other characteristics of subjects described? ???
  2.4. Were the subjects/patients a representative sample of the relevant population? ???
3. Were study groups comparable? No
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) ???
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? ???
  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? ???
  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? ???
  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%.) ???
  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? ???
  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.) ???
  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? ???
  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? ???
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? ???
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? ???
  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? ???
  7.2. Were nutrition measures appropriate to question and outcomes of concern? ???
  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? ???
  7.5. Was the measurement of effect at an appropriate level of precision? ???
  7.6. Were other factors accounted for (measured) that could affect outcomes? ???
  7.7. Were the measurements conducted consistently across groups? ???
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? ???
  8.2. Were correct statistical tests used and assumptions of test not violated? ???
  8.3. Were statistics reported with levels of significance and/or confidence intervals? ???
  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)? ???
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? ???
  8.6. Was clinical significance as well as statistical significance reported? ???
  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? ???
  9.2. Are biases and study limitations identified and discussed? ???
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? ???
  10.2. Was the study free from apparent conflict of interest? ???