Obesity, Childhood
Conditions
Keywords
prebiotics, Gastrointestinal Microbiome, Hispanic or Latino
Brief summary
The purpose of this study was to determine the feasibility, acceptability, and initial efficacy of combining prebiotic (Beneo Synergy 1) and calcium treatment with Project FUN (an online nutrition and physical activity program) on body composition and intestinal microbiota among 4th and 5th grade children whose social determinants placed them at higher risk for obesity. This aim was addressed through testing the following hypotheses: H1 Prebiotic and calcium supplementation in combination with Project FUN, will result in improved body composition scores, dietary fat percentage, and physical activity compared to a usual class control who did not receive the intervention. H2 Higher counts of Bacteroides and Bifidobacterium as well as fewer Firmicutes in the stool samples will correlate with improvement in body composition scores. Since this was a pilot community-based efficacy study, the following feasibility, acceptability, and descriptive research questions were also addressed: RQ1 What percentages of participants submit stool samples, body composition assessments and complete at least 70 percent of the intervention over the course of a 12-week study? RQ2 What is the relationship between changes in body composition scores, dietary fat percentage, physical activity and microbiota in stool samples before and after the 12-week intervention?
Detailed description
The purpose of this study was to determine the feasibility, acceptability, and initial efficacy of combining prebiotic (Beneo Synergy 1) and calcium treatment with Project FUN (an online nutrition and physical activity program) on body composition and intestinal microbiota among 4th and 5th grade children whose social determinants placed them at higher risk for obesity. This aim was addressed through testing the following hypotheses: H1 Prebiotic and calcium supplementation in combination with Project FUN, will result in improved body composition scores, dietary fat percentage, and physical activity compared to a usual class control who did not receive the intervention. H2 Higher counts of Bacteroides and Bifidobacterium as well as fewer Firmicutes in the stool samples will correlate with improvement in body composition scores. Since this was a pilot community-based efficacy study, the following feasibility, acceptability, and descriptive research questions were also addressed: RQ1 What percentages of participants submit stool samples, body composition assessments and complete at least 70 percent of the intervention over the course of a 12-week study? RQ2 What is the relationship between changes in body composition scores, dietary fat percentage, physical activity and microbiota in stool samples before and after the 12-week intervention? The sample included 4th- 5th grade students at two private urban schools where 98% were eligible for free or reduced fee lunch. Of the 123 consenting 56% were male; 71% Latinx; 15% African American; 14% Other. Three percent were underweight; 49% normal weight; 22% overweight; 25% obese. Consenting Latinx (n=20) and African American (n=8) participants completed microbiome analysis. Of these 54% were male; 6.5% underweight; 38.7% normal weight; 32.3% overweight; 2.6% obese.
Interventions
DIETARY_SUPPLEMENTBeneo Synergy 1
BEHAVIORALProject FUN
Project FUN, a culturally tailored online nutrition and physical activity program is based on the Health Promotion/ Transtheoretical Model. It includes 8 modules offered in a password-protected learning management system along with a workbook also used to assure intervention completion.
Sponsors
Medical College of Wisconsin
Marquette University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Research assistants collecting data did not know group assignment of participants.
Intervention model description
cluster randomized controlled feasibility trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* 4th- 5th grade students at two private urban schools where 98% were eligible for free or reduced fee lunch.
Exclusion criteria
* Parents indicated their child had taken an antibiotic in the last month since antibiotics can change intestinal flora though none required exclusion for this reason or for illness preventing participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body mass index percentile mean change from baseline after 12 weeks | Pre and after 12-week intervention | Weights to the nearest tenth of a pound were collected using a Seca model 8761321004 scale. Heights in stocking feet were measured to the nearest hundredth of an inch with a stadiometer (Seca Model 213, Hanover, MD, USA). Body mass index percentile was calculated using the Centers for Disease Control and Prevention school algorithm including birth date, measurement date, height, and weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body fat percentage mean change from baseline after 12 weeks | Pre and after 12-week intervention | Measured with the Omron HBF-306C hand-held bioimpedance monitor |
| Gut microbiota mean change from baseline after 12 weeks (Intervention group only) | Pre and after 12-week intervention | Genomic markers of stool samples were analyzed by Roche 454 pyrosequencing of fecal 16S rDNA and validated by quantitative polymerase chain reaction. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dietary fat percentage mean change from baseline after 12 weeks | Pre and after 12-week intervention | A 21-item, five-option response format measure was used developed by Prochaska JJ, Sallis JF, Rupp J. Screening measure for assessing dietary fat intake among adolescents. |
| Physical activity mean change from baseline after 12 weeks | Pre and after 12-week intervention | Prochaska JJ, Sallis JF, Long B. A physical activity screening measure for use with adolescents in primary care. |
Outcome results
None listed