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Citation:

Beech BM, Klesges RC, Kumanyika SK, Murray DM, Klesges L, McClanahan B, Slawson D, Nunnally C, Rochon J, McLain-Allen B, Pree-Cary J. Child- and parent-targeted interventions: The Memphis GEMS pilot study. Ethn Dis. 2003 Winter; 13 (1 Suppl 1): S40-S53.


PubMed ID: 12713210
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
POSITIVE: See Research Design and Implementation Criteria Checklist below.
Research Purpose:

To assess the feasibility, acceptability, and outcomes of two versions (child-based and parent- or caregiver-based) of a culturally relevant, family-based intervention to prevent excess weight gain and obesity in pre-adolescent African-American girls (pilot study). 

Inclusion Criteria:
  • African-American girls aged eight to 10 years and their parents or caregivers
  • Girls at or above the 25th percentile of age- and sex-based body mass index (BMI) based on the 2000 CDC growth charts
  • Able to participate in physical education classes at school.
Exclusion Criteria:

Age-eligible female sibling(s) of randomized child (but allowed to attend intervention sessions).

Description of Study Protocol:

Recruitment

Public service announcements on several local African-American radio stations, participation of GEMS investigators in live radio talk shows, and flyers distributed at local elementary schools.

Design

Randomized controlled trial (three arms).

Dietary Intake/Dietary Assessment Methodology

  • Two dietary recalls on non-consecutive days (within two weeks); parental assistance allowed:
    • Face-to-face
    • Telephone interview
  • Recall data was averaged over the two days for nutrient analysis
  • Recall data was summed over two days for fruit, vegetables, juice, sweetened beverages and water.

Interventions

  • Child-targeted intervention (GEMS Jamboree): 12 weekly 90-minute sessions, including: 
    • 15-minute introduction
    • 30-minute physical activity component (hip-hop aerobics was the main activity)
    • 30-minute nutrition component; taste-testing, food preparation, label-reading, healthy snacks and recipes were provided
    • 15-minute review segment with the distribution of small gifts
  • Parent-targeted intervention (Eating and Activity Skills for Youth—EASY)
    • 12 weekly, 90-minute sessions
      • Physical activity segment: Dancing to 1970s and 1980s music
      • interactive and didactic nutrition segment: Food preparation and nutrition-related games
      • Review of key points and provision of take-home materials (recipes, small incentives)
    • Childcare was provided (did not focus on nutrition or physical activity) 
  • Comparison intervention
    • Designed to enhance and prevent a decline in self-esteem, and neutrality with respect to dietary practices and physical activity
    • Three monthly 90-minute sessions
      • 15-minute introduction
      • Two 35-minute activity segments
      • 15-minute closing segment
    • Activity segments consisted of arts and crafts, 'friendship-building' and social support-type activities ('trust games') and enjoyable games
    • Mailings of personalized greeting cards and general health information to maintain contact and build rapport.

Statistical Analysis

  • Baseline variables analyzed with Fisher exact test (binary variables), Pearson chi-square and Mantel-Haenszel procedures (ordinal variables) and ANOVA (continuous variables)
  • ANCOVA was used to determine if there was a difference in outcome variables between baseline and 12-week follow-up (dependent variable); study condition was the grouping factor (three levels); the dependent variable was adjusted for baseline values
  • A 10% increase in physical activity, 10% decrease in sweetened beverage consumption and 10% increase in water consumption were arbitrarily assigned statistical significance.
Data Collection Summary:

Timing of Measurements

Assessments were conducted at baseline and at the end of the 12-week intervention [except dual energy X-ray absorptiometry (DEXA), which was only performed at baseline].

Dependent Variables

  • Height, weight and waist circumference: Measured directly
  • Sexual maturation: Direct observation by nurses
  • Dietary intake: Two dietary recalls (in-person and telephone)
  • Physical activity:
    • Computer Science Applications accelerometer worn for three consecutive days, which measured average daily counts per minute and minutes of moderate and vigorous physical activity between noon and 6:00 P.M.
    • Self-reported recall of previous day's activities and usual physical activity using the GEMS Activity Questionnaire
  • Insulin sensitivity
  • Glucose levels
  • Percent body fat: DEXA
  • Psychosocial variables:
    • Parent or caregiver food preparation practices: 25-item questionnaire (two of the sub-scales were low-fat food practices and high-fat food practices)
    • Girls' physical performance self-concept: Modified version of the Athletic Competence sub-scales form the Self-Perception Profile for Children, a nine-item sub-scale (α=0.70)
    • Girls' physical activity preference measures were used to assess 'active' and 'sedentary' activities with the modified Likert-type scale with physical activity preference (α=0.86) and sedentary activity preference (α=0.60)
    • Girls' self-efficacy for physical activity: Nine-item measure to assess perceived level of difficulty in engaging in activity (α=0.71)
    • Modified Stunkard, et al, body silhouettes: Used to assess girls' body image
    • Girls' weight control behaviors: Two sub-scales ['Moderate' (α=0.77) and 'Unhealthy'  (α=0.67) weight control behaviors] of the elementary version of the McKinght Risk Factor Survey.

Independent Variables

Three interventions.

Control Variables

Baseline values of the dependent variables.

Description of Actual Data Sample:
  • Initial N: 60 females (21 in the child-targeted intervention, 21 in the parent-targeted intervention and 18 in the comparison intervention)
  • Attrition (final N): 60
  • Age: Eight to 10 years
  • Ethnicity: African-American
  • Other relevant demographics: Subjects were representative of target population based on sociodemographic variables (35% with total annual household incomes less than $20,000 and 68% with less than $40,000; 50% of girls lived in female-headed households)
  • Anthropometrics: The comparison group included slightly older caregivers (P=0.048)
  • Location: Memphis, TN.
Summary of Results:

 Key Findings

  • Both active interventions were favored over the comparison group with respect to the majority of variables, but several outcomes from the parent intervention showed a trend toward an increased level of activity and fewer calories derived from fat, compared to the child intervention group
  • Girls in the active interventions combined showed a trend toward a reduced BMI compared to comparison group girls
  • Relative to girls in the comparison group, girls in the active interventions combined showed an 11.7% increase in minutes of moderate to vigorous physical activity, a 34.1% decrease in servings of sweetened beverages (P<0.05) and a 1.5% increase in servings of water
  • Girls in the comparison group (compared to both active intervention groups) showed a trend toward unhealthy behaviors and excessive concern about weight and shape.

Other Findings

  • Combining the two interventions (child-targeted and parent-targeted interventions) with some allowance for separate sessions would be better received than the separate intervention approaches for these African-American girls and their families
  • Only three girls provided blood samples.
Author Conclusion:

Overall, the study was implemented as designed, was well-received by participants and both active interventions were associated with some levels of behavior change in the expected directions.

Reviewer Comments:
  • Study strengths:
    • Interventionists (graduate students and members of the local community center trained as lay health educators) were provided with a two-day training and were tested and certified
    • A non-randomized 12-week feasibility study of the two active interventions was conducted prior to the pilot intervention (N=24 girls in the child intervention and N=15 parents in the parent intervention)
    • Retention rate was 100%, and attendance at intervention sessions was high (88% attended at least 80% of the scheduled intervention sessions)
    • Pilot study included a post-intervention evaluation of the results of the pilot study (34 interviews from a convenience sample)
    • The intervention was guided by the Social Cognitive Theory framework
  • Study limitations:
    • Only three girls provided blood samples (a separate consent form was provided for this part of the study)
    • There were fewer meetings for the comparison group vs. the active arms (three vs. 12), but mailings were provided for this group to maintain contact
    • This pilot study was not designed to show significant differences in physical measures (did not expect changes with the short study duration).

Research Design and Implementation 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 nutrition or dietetics practice?
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?
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)
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 used? (Concurrent preferred over historical controls.)
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?
N/A
  3.5. If case control or cross-sectional 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. Criterion may not be applicable in some cross-sectional studies.)
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?
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?
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.)
Yes
  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?
No
  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?
Yes
  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?
No
  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)?
???
  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