Dietary Fiber: Is it the Missing Link in Achieving Long Term Behavior Change?

NCT ID: NCT06227494

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fiber Intervention

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

Group Type EXPERIMENTAL

Fiber Intervention

Intervention Type BEHAVIORAL

Group education and phone-based motivational interviewing to gradually increase dietary fiber consumption to 30-35 grams per day.

Standard Weight Loss Education

Individuals in this arm will be given standard weight loss education

Group Type ACTIVE_COMPARATOR

Standard Weight Loss Education

Intervention Type BEHAVIORAL

Group education and phone-based motivational interviewing to promote current evidence-based behaviors to promote weight loss via achieving a negative energy balance.

Fiber Intervention + Standard Weight Loss Education

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

Group Type EXPERIMENTAL

Fiber Intervention

Intervention Type BEHAVIORAL

Group education and phone-based motivational interviewing to gradually increase dietary fiber consumption to 30-35 grams per day.

Standard Weight Loss Education

Intervention Type BEHAVIORAL

Group education and phone-based motivational interviewing to promote current evidence-based behaviors to promote weight loss via achieving a negative energy balance.

Interventions

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Fiber Intervention

Group education and phone-based motivational interviewing to gradually increase dietary fiber consumption to 30-35 grams per day.

Intervention Type BEHAVIORAL

Standard Weight Loss Education

Group education and phone-based motivational interviewing to promote current evidence-based behaviors to promote weight loss via achieving a negative energy balance.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18-65 years of age
* Dietary fiber intake ≤25 grams/day
* Self-reported BMI ≥30 kg/m2
* Willingness to attend in-person education sessions
* Willingness to avoid taking supplemental digestive aids (e.g., alpha-galactosidase (Beano®),
* Willingness to provide informed consent.

Exclusion Criteria

* Metabolic, digestive, or allergic conditions or reactions that preclude consumption of whole food or food groups (e.g., irritable bowel syndrome, diverticulosis)
* History of gastric bypass surgery
* Currently taking glucagon like glucagon-like peptide-1 (GLP-1) Receptor Agonists
* Self-reported history of a diagnosed eating disorder
* Chronic disease (other than obesity)
* Pregnancy or lactation
* Use of tobacco or electronic smoking products
* Taking a pre-, pro-, or syn-biotic supplement
* Enrollment in another weight loss or diet intervention
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oklahoma State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Oklahoma State University

Stillwater, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-23-59-STW

Identifier Type: -

Identifier Source: org_study_id

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