Fiber Intervention for Obesity

Overseen By Ashlea Braun, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oklahoma State University

Must not be taking: GLP-1 agonists, Prebiotics

Disqualifiers: Metabolic conditions, Gastric bypass, Eating disorder, Chronic disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

63 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking glucagon-like peptide-1 (GLP-1) Receptor Agonists and any pre-, pro-, or syn-biotic supplements. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What data supports the effectiveness of the Fiber Intervention treatment for obesity?

Research shows that educational interventions and regular follow-up can help people with obesity achieve healthier eating habits and weight loss. Additionally, a school-based program combining behavior modification, nutrition education, and physical activity led to significant weight loss in children, suggesting that similar comprehensive approaches can be effective. ^{1 2 3 4 5}

How does the Fiber Intervention treatment for obesity differ from other treatments?

The Fiber Intervention treatment for obesity is unique because it focuses on increasing dietary fiber intake, which can enhance feelings of fullness and reduce hunger, leading to lower energy intake and weight loss. Unlike other treatments, it emphasizes the use of both soluble and insoluble fiber from foods or supplements, which can also improve metabolic health and support weight management as part of a lifestyle change. ^{6 7 8 9 10}

What is the purpose of this trial?

The overall objective of this three-arm randomized controlled trial is to compare a dietary fiber-focused behavioral intervention to standard weight loss education for improving eating-related behavior and cognition, weight, and metabolic markers of chronic disease risk in a population of adults with obesity.

Eligibility Criteria

This trial is for adults with obesity who are interested in improving their eating habits, weight, and health markers related to chronic diseases. Participants must meet certain criteria set by the researchers but these specific requirements are not provided here.

Inclusion Criteria

Willingness to provide informed consent.

I am willing to not take any digestive aid supplements.

Dietary fiber intake ≤25 grams/day

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a dietary fiber-focused behavioral intervention or standard weight loss education

15 months

Regular visits for intervention and monitoring

Follow-up

Participants are monitored for safety and effectiveness after intervention

12 months

Periodic follow-up visits

Treatment Details

Interventions

• Fiber Intervention
• Standard Weight Loss Education

Trial Overview The study is testing whether focusing on dietary fiber can help people change their behavior and improve health more than just getting standard weight loss advice. It's a three-part test where participants are randomly assigned to one of the groups.

Participant Groups

Group I: Fiber Intervention + Standard Weight Loss Education Experimental Treatment 2 Interventions

Individuals in this arm will be given education on both fiber and standard weight loss

Group II: Fiber Intervention Experimental Treatment 1 Intervention

Individuals in this arm will be given instruction on how to increase fiber intake,

Group III: Standard Weight Loss Education Active Control 1 Intervention

Individuals in this arm will be given standard weight loss education

Who Is Running the Clinical Trial?

Oklahoma State University

Lead Sponsor

Trials

51

Recruited

8,600+

Findings from Research

In a study involving 116 patients over two years, educational measures and regular follow-ups significantly contributed to weight loss, with 5.1% achieving a weight reduction of at least 10%.

Patients who voluntarily discharged themselves showed the largest decrease in BMI (12.8), highlighting the importance of personal motivation in successful weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Results of educational intervention in obese patients]. Díaz Gómez, J., Armero Fuster, M., Calvo Viñuela, I., et al.[2013]

In a 10-week school-based program involving 63 obese children aged 5 to 12, 95% of participants lost weight, achieving an average weight loss of 4.4 kg and a 15.4% decrease in their percentage overweight.

The program was significantly more effective than no intervention, as only 21% of a control group of obese children lost weight, highlighting the importance of comprehensive behavior modification and support in managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A school-based behavior modification, nutrition education, and physical activity program for obese children. Brownell, KD., Kaye, FS.[2018]

High-fiber diets, which include non-starchy vegetables, fruits, whole grains, legumes, and nuts, are linked to better body-weight regulation and increased feelings of fullness, making them potentially effective for preventing and treating obesity in children.

In addition to aiding in weight management, fiber-rich diets may also help prevent cardiovascular disease and type 2 diabetes, offering further health benefits beyond just weight control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fiber and body-weight regulation. Observations and mechanisms. Pereira, MA., Ludwig, DS.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Weight reduction interventions for persons with a chronic illness: findings and factors for consideration. [2007]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Importance of age for 3-year continuous behavioral obesity treatment success and dropout rate. [2019]

3. Spain pubmed.ncbi.nlm.nih.gov

[Results of educational intervention in obese patients]. [2013]

4. England pubmed.ncbi.nlm.nih.gov

The development of a core outcomes set for self-management interventions for patients living with obesity. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A school-based behavior modification, nutrition education, and physical activity program for obese children. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Fiber and weight management. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Dietary fiber and weight regulation. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of isolated soluble fiber supplementation on body weight, glycemia, and insulinemia in adults with overweight and obesity: a systematic review and meta-analysis of randomized controlled trials. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Fiber intake of normal weight, moderately obese and severely obese subjects. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Dietary fiber and body-weight regulation. Observations and mechanisms. [2022]