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Citation:

Haire-Joshu D, Nanney MS, Elliott M, Davey C, Caito N, Loman D, Brownson RC, Kreuter MW. The use of mentoring programs to improve energy balance behaviors in high-risk children. Obesity. 2010; 18(Suppl 1): S75-S83.


PubMed ID: 20107465
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 test the impact of a multi-component intervention designed to improve diet and activity behaviors as an element of mentoring programs for high-needs children.

Inclusion Criteria:

Children enrolled in tutoring programs at OASIS and Big Brother Big Sister (BBBS) sites

Exclusion Criteria:

None listed.

Description of Study Protocol:

Recruitment

Participants who participated in tutoring programs at OASIS Intergenerational Reading Program (OASIS) and Big Brothers Big Sisters (BBBS) located in St Louis, MO  were recruited.

Design

Group randomized trial design.

Dietary Intake/Dietary Assessment Methodology

Child baseline and post-test evaluation on the following diet habits was obtained:

  • Assessing preferences for fruits and vegetables (FV)
  • FV knowledge
  • Challenging self to meet FV recommendations
  • Asking parent or guardian for FV for an after-school snack
  • Parental role modeling of healthy eating.

Intervention

Intervention  families received standard tutoring plus the PARADE (“Partners of All Ages Reading About Diet and Exercise”) program, where each module contained the following:

  • An individual visit lesson plan
  • A storybook
  • A parent action newsletter.

Statistical Analysis

  • Mixed effect models were used to evaluate the intervention effect from baseline to post-intervention in the cohort of students with data at both time points, adjusting outcomes in children for child age, gender, baseline BMI z-score and parent education, except BMI z-score outcomes which were adjusted for parent education only
  • Stratified analysis was also done to examine different effects between normal weight and overweight children.
Data Collection Summary:

Timing of Measurements

Baseline and post-test: 

  • The average time between the pre-test and the post-test was 5.7 months (range 2.1 to 16.2 months)
  • The average time between the pre-test and the post-test survey was 4.8 months (range 2.3 to 10.8 months).

Dependent Variables

  • Variable one: Child outcomes:
    • Preference for FV and activities 
    • FV and active play knowledge
    • Asking parent or guardian for FV for an afterschool snack and someone to play with parental role modeling of healthy eating and being active
    • BMI z-score 
    • Challenging self to eat five fruits or vegetables a day or to be active for at least one hour each day
  • Variable two: Parental outcomes:
    • Daily caloric intake
    • Percent of calories consumed from fat
    • Daily servings of FV
    • Minutes walked per week.

Independent Variables

PARADE, consisting of: 

  • Eight lesson plans
  • Eight computer tailored storybooks
  • Parent action newsletter.

Control Variables

  • Site was included as an effect in these models as appropriate for a group randomized trial design.
  • Outcomes in children were adjusted for child age, gender, baseline BMI z-score and parent education, except BMI z-score outcomes, which were adjusted for parent education only.
Description of Actual Data Sample:
  • Initial N: 782 children and a parent each (intervention, N=418 children at 74 sites; control, N=364 at 45 sites) in the original PARADE study
  • Attrition (final N): Analysis limited to 451 children (intervention, N=296 children at 69 sites; control, N=155 at 43 sites); parent interview outcomes limited to 279 children (intervention, N=124; control, N=72)
  • Age: Five- to 12-year-old children
  • Ethnicity: White and other
  • Other relevant demographics: PARADE kids slightly younger and PARADE parents had higher  education (P=0.01) and income (P=0.08) than control group
  • Anthropometrics: No significant differences in weight status among children and parents in the two groups 
  • Location: St Louis, MO.
Summary of Results:

Variables

PARADE Group

Measures and Confidence Intervals

Control Group

Measures and Confidence Intervals

Statistical Significance of Group Difference

Child outcomes

Knowledge of healthy eating higher (mean change 27.9)

Mean change 4.17  P<0.01 
 

Higher proportion of children challenged themselves to eat five FV (mean change 23.3) and be more active (mean change 21.0)

Five FV: Mean change 3.59

Activity: Mean change 0.04

P=0.04

P=0.02

 

BMI z-score decreased more (mean change -0.47)

Mean change -0.016  P=0.42
  FV preference: Mean change 0.50

Higher preference for variety in FV (mean change 1.05) and wanting to be active (mean change 12.06) 

FV: P=0.690

Activity: P=0.208 

 

Active: Mean change 0.60

Knowledge: Mean change 6.82 P=0.0002 
 

Normal weight children improved knowledge, (mean change 27.40) frequency of challenging selves to be more active (mean change 22.69) and eat more FV (mean change 28.09)

Active: Mean change -11.48

FV: Mean change -7.18 

P=0.0001

P=0.0002 

Parental outcomes

More walking minutes (mean change 228.3) Mean change 9.42 P=0.139
 

Higher FV intake (mean change 4.40)

Mean change 3.99

P=0.923

Other Findings

  • 84% parents read storybooks with their child
  • 88% reported child-preferred PARADE book as much or more than other books
  • Mentors documented:
    • Attendance
    • Content delivery
    • Student response to storybooks and participation in discussions. 
Author Conclusion:
  • The combination of one-to-one mentoring, child-focused computer-based tailoring and parent support may impact important behavioral change precursors in environments over which the child has control, especially among normal weight children
  • Further, work is needed to evaluate the impact of family-focused multi-component interventions, including computer-tailored approaches, directed toward both the parent and the child.
Reviewer Comments:
  • This study describes in detail a multi-component, community-based approach to influence select diet and activity patterns of high-risk five- to 12-year-old children and their parents or guardians and highlights the importance of parents being role models of healthy behaviors, while children in the intervention group had increased awareness of healthier foods and portions and activity, involving the parents in the education model helps heighten their awareness to model positive behaviors
  • However, the applicability of this model in rural areas, in ethnically diverse populations and cognitively and socially challenged kids remains to be determined
  • Ethnicity of non-white participants was not disclosed.

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.)
Yes
  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?
N/A
  4.1. Were follow-up methods described and the same for all groups?
N/A
  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%.)
N/A
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for?
N/A
  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.)
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
  5.5. 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?
???
  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?
Yes
  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?
???
  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)?
N/A
  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?
N/A
  8.7. If negative findings, was a power calculation reported to address type 2 error?
Yes
9. Are conclusions supported by results with biases and limitations taken into consideration?
Yes
  9.1. Is there a discussion of findings?
Yes
  9.2. 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