Combining Prebiotic and Diet/Physical Activity Educational Program Effects on Body Composition and Intestinal Microbiota in Children

NCT05671731 | Completed

• 1 other identifier: 2411
• Study Type: interventional
• Target: 123
• Locations: 0 countries
• Sites: N/A

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?

Conditions

Obesity, Childhood

Keywords

prebiotics; Gastrointestinal Microbiome; Hispanic or Latino

Outcome Measures

Primary Outcomes (1)

• Body mass index percentile mean change from baseline after 12 weeks

  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

  Pre and after 12-week intervention

Secondary Outcomes (2)

• Body fat percentage mean change from baseline after 12 weeks

  Pre and after 12-week intervention

• Gut microbiota mean change from baseline after 12 weeks (Intervention group only)

  Pre and after 12-week intervention

Other Outcomes (2)

• Dietary fat percentage mean change from baseline after 12 weeks

  Pre and after 12-week intervention

• Physical activity mean change from baseline after 12 weeks

  Pre and after 12-week intervention

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group received Beneo Synergy 1 - 4gm twice/school day in 4 ounces orange juice with calcium for 12 weeks. We started with 1gm then increased the next day by a gram to reach the 4gm dose. Intervention group participants completed Project FUN (8 module online nutrition and physical activity program) individually (password protected) in the school computer lab along with a workbook also used to check intervention completion.

Dietary Supplement: Beneo Synergy 1; Behavioral: Project FUN

Control

NO INTERVENTION

The control group participated in usual school activities only completing pre and post measures.

Interventions

Beneo Synergy 1 DIETARY_SUPPLEMENT

Also known as: oligofructose enhanced inulin

Intervention

Project FUN BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• th- 5th grade students at two private urban schools where 98% were eligible for free or reduced fee lunch.

Sponsors & Collaborators

• Marquette University: lead
• Medical College of Wisconsin: collaborator

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistants collecting data did not know group assignment of participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cluster randomized controlled feasibility trial

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 5, 2023
• Study Start: November 13, 2012
• Primary Completion: April 11, 2013
• Study Completion: April 11, 2013
• Last Updated: January 5, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share