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Citation:

Baranowski T, Baranowski JC, Cullen KW, Thompson DI, Nicklas T, Zakeri IE, Rochon J. The Fun, Food, and Fitness Project (FFFP): the Baylor GEMS pilot study. Ethn Dis. 2003 Winter;13(1 Suppl 1):S30-9. 


PubMed ID: 12713209
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
NEUTRAL: See Research Design and Implementation Criteria Checklist below.
Research Purpose:

To test the effectiveness of the Girls health Enrichment Multi-site Studies (GEMS) Fun, Food, and Fitness Project (FFFP) to prevent associated measurements related to obesity among 8-year-old African-American girls.

Inclusion Criteria:

Subjects were 8-year old African-American girls who:

  • had a parent also willing to participate,
  • were in the > 50th percentile for age and gender body mass index (BMI),
  • had a home computer with Internet access, and
  • provided informed consent.
Exclusion Criteria:

Subjects were excluded if they had a medical condition or took medicine affecting growth, had conditions that would limit ability to participate in the intervention or the measurements needed for assessment.

Description of Study Protocol:

Recruitment

Volunteer subjects were recruited from radio advertisement, Website, fliers, church and social group presentations and postcards.

Design:  Randomized controlled pilot study trial

Blinding used

Subjects were blinded to assignment.  Intervention and control subjects were coordinated through two separate camps.  Investigators were not blinded after assignment.

Intervention

4-week day-camp activities and following 12-week Internet activities included more focused Social Cognitive Theory interventions to encourage the following:

  1. Increase preference and consumption of fruits, 100% juice and vegetables
  2. Increase preference and consumption of water
  3. Increase physical activity

Statistical Analysis

Data analyzed with intention-to-treat principles including:

  • Two-sided test of significance
  • ANCOVA
  • Poisson regression 
Data Collection Summary:

Timing of Measurements

Baseline characteristics and measurements of demographics, body mass index, waist circumference, physical maturation, body fat percentage, diet , physical activity, preference for physical activity and sweetened beverages, race and ethnicity.

Dietary intake was assessed through two 24-hour dietary recall reports (within 2 weeks of each other) at baseline and after the 12-week intervention.

Dependent Variables

  • Consumption of fruits, juice and vegetables
  • Change in BMI
  • Consumption of water
  • Level of physical activity

Independent Variables

  • Intervention group:  special 4-week summer day camp followed by a special 8-week home Internet intervention for the girls and their parents
  • Control group:  different 4-week summer day camp followed by a monthly home Internet intervention, neither of which components included the GEMS-FFFP enhancements 

Control Variables

  • Age
  • Sex
  • Race
  • Sexual maturation
  • Household income
  • Household education
  • Female-headed household
  • Camp duration
  • Internet access
Description of Actual Data Sample:

Initial N: 35 female participants and their adult partners

Attrition (final N): 35, 19 in the intervention group, 16 in the control group

Age: 8-years old

Ethnicity: African-American

Other relevant demographics:  Intervention and control groups were comparable age, household income, household education and age of caregiver.

Anthropometrics:

Control subjects had a higher body mass index, pubertal age and body fat percentage at baseline.

Location: Houston, TX

 

Summary of Results:

Key Findings

  • Participation rates in day camp programs were very high, despite severe weather in the area at the time.
  • Participation rates in Internet follow up programs were low (below 50%) for both girls and parents despite email reminders, encouraging activities and monetary rewards.  Participation in the control group was even less than intervention.
  • After adjusting for baseline BMI, there were no significant differences in BMI between treatment and control group girls, either at the end of the 4-week summer day camp, or after the full 12-week intervention.
  • By the end of the summer day camp, the subgroup of treatment group girls heavier at baseline exhibited a trend (P < 0.08) toward lower BMI, compared to their heavier counterparts in the control group.
  • Control group showed positive improvement in diet intake (-231.5 kcal per day and increase 1.2 times servings fruits, juice, and vegetables) and water consumption (40% increase and 20% reduction in sweetened beverages) although BMI and activity did not change appreciably.
  • Overall results at the end of the 12-week program demonstrated substantial, although not significant, differences between treatment and control groups in the hypothesized directions
  12-week Follow-up Intervention Mean (SD) (N=17) Control Mean (SD) (N=14) Adjusted difference or estimated ratio (SE) P value
Body Mass Index (kg/m2) 24.6 (1.0) 24.1 (1.1) 0.6 (1.6) .72
Waist Circumference (cm) 74.1 (0.9) 71.7 (1.0) 2.4 (1.4) .10
Computer Science Applications (CSA), 24 hr (counts/min) 369.9 (22.0) 364.0 (25.8) 6.0 (34.4) .86
CSA, mod to vigorous (counts/min) 67.5 (7.6) 74.8 (8.9) -7.3 (11.8) .54
CSA, noon-6 (counts/min) 606.2 (40.1) 597.9 (46.9) 8.3 (62.1) .89
MET adjusted GAQ-usually 5.1 (0.4) 4.3 (0.5) 0.8 (0.6) .19
Total kCal 1678 (137.1) 1909 (155.8) -231.5 (209.1) .28
% kCal from fat 33.1 (1.2) 34.7 (1.3) -1.6 (1.8) .39
FJV, servings 4.9 (0.6) 4.1 (0.6) 1.2 (0.2) .36
Sweetened beverages, servings 2.9 (0.6) 3.6 (0.7) 0.8 (0.2) .42
Water, servings 1.3 (0.3) 0.9 (0.3) 1.4 (0.5) .41
Physical activity preference 2.5 (0.1) 2.4 (0.1) 0.1 (0.2) .62
Sweetened beverage preference 1.7 (0.1) 1.8 (0.2) -0.1 (0.2) .58

 

 

Author Conclusion:

This study indicates the potential positive impact of summer day camps and the need for additional research on maximizing Internet log-on rate and activity in the prevention of obesity in young African-American girls.

Reviewer Comments:

The authors cited strengths include strong theoretical framework, randomization, participatory controls and process evaluation.  The limitations include very small sample, self-reported dietary intake and the differences in BMI between the control and intervention groups at baseline.  The authors note that while the study was not powered to detect such an effect, no trend for a difference in the hypothesized direction was evident.

 


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?
???
  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?
???
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)
Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?
No
  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?
Yes
  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?
Yes
  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.)
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?
???
  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?
???
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described?
Yes
  6.6. Were extra or unplanned treatments described?
Yes
  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?
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?
???
  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?
???
  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)?
Yes
  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
 
 

Copyright American Dietetic Association (ADA).