Web Based Intervention to Reduce Weight Bias Among Dietitians

January 7, 2020 updated by: Emily Dhurandhar, Texas Tech University
Weight bias in dietitians is prevalent and may affect patient care. The investigators conducted a randomized controlled trial to test if explicit and implicit bias could be influenced by a short, 20 minute educational video.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This randomized controlled trial studied the effect of three different videos on weight bias in a nationally representative sample of dietitians. The "intervention" group (I) watched a video about the etiology of obesity, reasons for weight regain, and how to talk to patients about weight. The first "control" group (C1) received information about the role of the environment and individual behavior in weight gain, and tools to help patients control their weight. The second control group (C2) received a weight neutral video about the role of dieticians in society. Bias measures were taken before and just after watching the video, and again one month later.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
166

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Lubbock, Texas, United States, 79409
        • Texas Tech University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any dietitian in the Clinical Dietitian Registry Database.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention (I)
This arm was randomized to a 20 min video that emphasized information about factors other than individual behaviors that influence weight, weight loss and ability to maintain weight. It also indirectly addressed weight bias by explaining how to have conversation about weight and health with a patient with obesity that is free of biases.
Other: Online Educational Videos
The videos were developed by the researchers based on a prior study to test if specific information about obesity and weight control influence weight bias.
Active Comparator: Weight Control (C1)
This arm was randomized to a 20 min video that emphasized the controllable aspects of weight and gave dietitians an overview of a tool to help plan and monitor weight loss.
Other: Online Educational Videos
The videos were developed by the researchers based on a prior study to test if specific information about obesity and weight control influence weight bias.
Placebo Comparator: Weight Neutral Control (C2)
The arm was randomized to a 20 min video about the role dietitians play in society, that made no mention of weight or obesity.
Other: Online Educational Videos
The videos were developed by the researchers based on a prior study to test if specific information about obesity and weight control influence weight bias.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in "Blame" explicit bias
Time Frame: Change from pre to immediately post intervention (1 hour)
"Blame" subscore of Anti-fat Attitudes Test, higher score means more bias
Change from pre to immediately post intervention (1 hour)
Change in "Blame" explicit bias
Time Frame: Change from pre to 1 month post intervention
"Blame" subscore of Anti-fat Attitudes Test, higher score means more bias
Change from pre to 1 month post intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in "Social" explicit bias
Time Frame: Change from pre to immediately post intervention (1 hour)
"Social" subscore of Anti-fat Attitudes Test, higher score means more bias
Change from pre to immediately post intervention (1 hour)
Change in "Social" explicit bias
Time Frame: Change from pre to 1 month post intervention
"Social" subscore of Anti-fat Attitudes Test, higher score means more bias
Change from pre to 1 month post intervention
Change in "Physical" explicit bias
Time Frame: Change from pre to immediately post intervention (1 hour)
"Physical" subscore of Anti-fat Attitudes Test, higher score means more bias
Change from pre to immediately post intervention (1 hour)
Change in "Physical" explicit bias
Time Frame: Change from pre to 1 month post intervention
"Physical" subscore of Anti-fat Attitudes Test, higher score means more bias
Change from pre to 1 month post intervention
Change in Implicit Bias
Time Frame: Change from pre to immediately post intervention (1 hour)
Category of bias from Weight Implicit Association Test; Categories 1-4, higher category means more bias
Change from pre to immediately post intervention (1 hour)
Change in Implicit Bias
Time Frame: Change from pre to 1 month post intervention
Category of bias from Weight Implicit Association Test; Categories 1-4, higher category means more bias
Change from pre to 1 month post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Tech University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 8, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 8, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB2019-321

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We have a primary and secondary analysis planned for these data, once they are both published we will share the data within 6 months time via ICSPR database.

IPD Sharing Time Frame

Within 6 months of publication, data will be available.

IPD Sharing Access Criteria

Public Access Database.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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