ObesityNCT06227494
Dietary Fiber: Is it the Missing Link in Achieving Long Term Behavior Change?
A study testing Fiber Intervention and Standard Weight Loss Education in people with Obesity, run by Oklahoma State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Fiber Intervention and Standard Weight Loss Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2023to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Use of tobacco or electronic smoking products
- Taking a pre-, pro-, or syn-biotic supplement
- Enrollment in another weight loss or diet intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma State University
Stillwater, Oklahoma, 74078
About this study
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.
- Conditions
- Obesity
- Being tested
- Fiber Intervention, Standard Weight Loss Education
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiber InterventionBehavioural
Group education and phone-based motivational interviewing to gradually increase dietary fiber consumption to 30-35 grams per day.
Standard Weight Loss EducationBehavioural
Group education and phone-based motivational interviewing to promote current evidence-based behaviors to promote weight loss via achieving a negative energy balance.
| Study group | Role | What they receive |
|---|---|---|
| Fiber Intervention | Experimental | Individuals in this arm will be given instruction on how to increase fiber intake, Receives: Behavioral: Fiber Intervention |
| Standard Weight Loss Education | Active comparator | Individuals in this arm will be given standard weight loss education Receives: Behavioral: Standard Weight Loss Education |
| Fiber Intervention + Standard Weight Loss Education | Experimental | Individuals in this arm will be given education on both fiber and standard weight loss Receives: Behavioral: Fiber Intervention; Behavioral: Standard Weight Loss Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measure of body weight/mass
Measured: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Secondary outcomes (14)
Body composition (fat mass, lean mass)
Dual x-ray absorptiometry (DEXA) scans
Measured: Measured at baseline (time 1, month 0) and post-observation (time 3, month 27)
Fecal short chain fatty acids
Taken from fecal samples collected at home
Measured: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Fecal bacteria measured using 16S ribosomal ribonucleic acid (rRNA) sequencing
Will include measures of diversity, abundance, etc.
Measured: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Total Cholesterol
Measured via blood samples (unit= milligram/deciliter (mg/dL))
Measured: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Fasting blood glucose
Measured via blood samples (unit=mg/dL)
Measured: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 33, month 27)
Healthy Eating Index Scores measured using Health Eating Index 2020 (HEI-2020)
Taken from 3 day diet records (score range=0-100, higher=better diet quality)
Measured: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Three-Factor Eating Questionnaire
Resulting scores in uncontrolled eating (range=9-36), cognitive restraint (range=3-12), and emotional eating (range=6-24); higher scores indicate more of that particular eating behavior
Measured: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Implicit Association Test
Represented with a total D variable (No range, but more negative = greater preference for unprocessed food)
Measured: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Behavioral Inhibition System/Behavioral Approach System (BIS/BAS) Scale
Score ranges from 20 to 80, with higher scores indicating greater behavioral inhibition and behavioral activation
Measured: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Executive Function: Tower Test (Delis-Kaplan Executive Function System)
Total Achievement Score (range=0-30, higher = higher executive function)
Measured: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Executive Function: Color-Word Interference Test (Delis-Kaplan Executive Function System)
Scaled inhibition/switching scores (score range=1-19, higher = higher executive function)
Measured: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Skin Carotenoid scores measured via the Veggie Meter
Veggie Meter; score range 0-800 (higher=greater skin carotenoids (i.e., consumption of more fruits/vegetables)
Measured: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
High-density lipoprotein (HDL) cholesterol
Measured via blood samples (unit=mg/dL)
Measured: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Low-density lipoprotein (LDL) cholesterol
Measured via blood samples (unit=mg/dL)
Measured: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start10 Jul 2023
- Primary completion31 Jan 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227494
- Sponsor's protocol ID
- IRB-23-59-STW
- Status last verified
- Sep 2025
- First submitted
- 28 Jul 2023
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Fiber: Is it the Missing Link in Achieving Long Term Behavior Change?
- ClinicalTrials.gov ID
- NCT06227494
- Acronym / sponsor ID
- IRB-23-59-STW
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fiber Intervention | Experimental | Behavioral: Fiber InterventionIndividuals in this arm will be given instruction on how to increase fiber intake, |
| Standard Weight Loss Education | Active comparator | Behavioral: Standard Weight Loss EducationIndividuals in this arm will be given standard weight loss education |
| Fiber Intervention + Standard Weight Loss Education | Experimental | Behavioral: Fiber Intervention, Behavioral: Standard Weight Loss EducationIndividuals in this arm will be given education on both fiber and standard weight loss |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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®),
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fiber InterventionGroup education and phone-based motivational interviewing to gradually increase dietary fiber consumption to 30-35 grams per day. | Behavioural | Fiber Intervention, Fiber Intervention + Standard Weight Loss Education |
| Standard Weight Loss EducationGroup education and phone-based motivational interviewing to promote current evidence-based behaviors to promote weight loss via achieving a negative energy balance. | Behavioural | Fiber Intervention + Standard Weight Loss Education, Standard Weight Loss Education |
Primary outcome
Body weight
Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Measure of body weight/mass
14 secondary outcomes
Body composition (fat mass, lean mass)
Time frame: Measured at baseline (time 1, month 0) and post-observation (time 3, month 27)
Fecal short chain fatty acids
Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Fecal bacteria measured using 16S ribosomal ribonucleic acid (rRNA) sequencing
Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Total Cholesterol
Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Fasting blood glucose
Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 33, month 27)
Healthy Eating Index Scores measured using Health Eating Index 2020 (HEI-2020)
Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Three-Factor Eating Questionnaire
Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Implicit Association Test
Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Behavioral Inhibition System/Behavioral Approach System (BIS/BAS) Scale
Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Executive Function: Tower Test (Delis-Kaplan Executive Function System)
Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Executive Function: Color-Word Interference Test (Delis-Kaplan Executive Function System)
Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Skin Carotenoid scores measured via the Veggie Meter
Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
High-density lipoprotein (HDL) cholesterol
Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Low-density lipoprotein (LDL) cholesterol
Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiber Intervention and Standard Weight Loss Education in people with Obesity, run by Oklahoma State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.