BABE(Body Appreciation and Better Eating), Add Some Self-compassion (BABE)

May 8, 2023 updated by: Nkechi Okpara, University of South Carolina

BABE(Body Appreciation and Better Eating), Add Some Self-compassion: a Randomized Controlled Pilot Study for Black/African American High School Teenage Girls

Body dissatisfaction is most common among girls in their teenage years and young adulthood, this is also around the time where the risk of developing binge eating disorder is the highest. Black/African American girls are more likely to engage in binge eating behaviors compared to their White American counterparts; however, they receive less help for eating issues. Further, increase rates of obesity in the Black/African American population may indicate that binge eating may be a bigger problem for this population than discussed. Therefore, the primary purpose of this randomized controlled pilot is to assess the feasibility of this pilot study to be used in a large scale fully-powered study. The secondary purpose of this study is to assess if two different nutrition and body image programs elicit positive outcomes among Black/African American teenage girls who indicate a desire to improve body image.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.

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.
13

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • University of South Carolina

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

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female
  • Black (Afro-Latina)/African American teenage girls
  • Age 13 to 18 years old
  • Attend high school in the United States
  • Interest in nutrition

Exclusion Criteria:

  • Eating disorder diagnosis
  • Pregnancy

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: Prevention
  • 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: Body image + nutrition education +self-compassion
For the treatment arm, girls will participate in the Body Project for about 30 minutes, then will be given about a 30 minute self-compassion-based nutrition education lesson. The nutrition topics will cover the basic biochemistry of nutrition, nutrition needs for teenage girls, and ways to find balance in eating, framed in the constructs of self-compassion. The three self-compassion constructs will be targeted in the following ways: (1) Mindfulness will involve bringing awareness to feelings and emotions about a time during the week where participants ate a food lower in nutritional value. (2) Common Humanity involves finding ways in which their experience connects to others and acknowledging that being human comes with imperfections. (3) Self-Kindness will involve having girls speak kind and understanding words to themselves as it relates to their eating-related downfall of the week.
Behavioral: BABE (Body Appreciation and Better Eating)
The participants will be randomized into either a treatment or control group. For the treatment arm, girls will participate in the Body Project for 30 minutes, then will be given a 30-minute self-compassion-based nutrition education lesson. Nutrition topics will cover the basic biochemistry of nutrition, nutrition needs for teenage girls, and ways to find balance in eating, framed in the constructs of self-compassion. The control group will receive the same 30-minute Body Project class and the same 30-minute nutrition education class; however, there will be no incorporation of self-compassion.
Active Comparator: Body image + nutrition education
For the control arm, participants will receive the same 30-minute Body Project class, then participants will be given a 30-minute nutrition education lesson. The nutrition lesson plans will have no components of self-compassion intertwined within the lesson, but the nutrition content will be the same as the treatment group.
Behavioral: BABE (Body Appreciation and Better Eating)
The participants will be randomized into either a treatment or control group. For the treatment arm, girls will participate in the Body Project for 30 minutes, then will be given a 30-minute self-compassion-based nutrition education lesson. Nutrition topics will cover the basic biochemistry of nutrition, nutrition needs for teenage girls, and ways to find balance in eating, framed in the constructs of self-compassion. The control group will receive the same 30-minute Body Project class and the same 30-minute nutrition education class; however, there will be no incorporation of self-compassion.

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
Feasibility of the BABE program (sample size)
Time Frame: 12 weeks
The feasibility of this randomized controlled pilot will consider sample size. Feasibility will be measured by the length of time required to complete participant recruitment (=20-24).
12 weeks
Feasibility of the BABE program (randomization)
Time Frame: 12 weeks
The feasibility of this randomized controlled pilot will consider randomization. Feasibility will be measured by the ability to randomize participants (if researcher needs to add additional class options to accommodate teen girls).
12 weeks
Feasibility of the BABE program (retention)
Time Frame: 12 weeks
The feasibility of this randomized controlled pilot will consider retention. Feasibility will be measured by the retention rate/response rate (100 %) at 1-month follow-up.
12 weeks
Participants' acceptability of the program
Time Frame: 12 weeks
Program acceptability will be measured by focus groups conducted post-intervention and a credibility scale which will be given after classes. The Credibility scale measures the degree to which participants believe their intervention is credible and effective in improving outcomes (body image and nutrition). Some of the question items included, "How logical is this program in helping you improving eating habits? How logical is this program in helping you improve body image? Responses are indicated on a 9-point Likert scale of 0 (not at all) to 9 (very). Higher scores mean better outcomes.
12 weeks

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
Self-compassion for youth scale
Time Frame: 12 weeks
My secondary objectives will test within and between groups (treatment vs control) changes in self-compassion. The Self-Compassion Scale for youth consists of 17 items to assess self-compassion through the components of self-kindness, self-judgment. Responses are indicated on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always). Higher scores mean better outcomes.
12 weeks
Body Appreciation Scale-2
Time Frame: 12 weeks
My secondary objectives will test within and between groups (treatment vs control) changes in body appreciation. The Body appreciation scale-2 (BAS-2) consists of 10 items that measure body appreciation by assessing individuals' acceptance of favorable opinions towards and respect for their bodies. Responses are indicated on a 5-point Likert scale from 1 (never) to 5 (always). Higher scores mean better outcomes.
12 weeks
Mindful eating questionnaire
Time Frame: 12 weeks
My secondary objectives will test within and between groups (treatment vs control) changes in mindful eating. The Mindful Eating Questionnaire for Children (MEQ-C) is a 17-item questionnaire that consists of five subscales: disinhibition, awareness, external cues, emotional response, and distraction. Responses are indicated on a Likert scale from 1 (never/rarely) to 4 (usually/always), with higher scores indicating greater degrees of mindful eating.
12 weeks
Childrens Brief Binge Eating Questionnaire
Time Frame: 12 weeks
My secondary objectives will test within and between groups (treatment vs control) changes in binge eating. The Children's Brief Binge-Eating Questionnaire (CBBEQ) consists of 7 questions and responses are provided on a Likert-type scale from "Definitely false" (0) to "Definitely true" (3). Higher scores mean greater risk for binge eating disorder.
12 weeks
Motivations for Electronic Interaction Scale (MEIS)
Time Frame: 12 weeks
My secondary objectives will test within and between groups (treatment vs control) changes in motivation for using social media. The Motivations for Electronic Interaction Scale (MEIS) assesses adolescents' attitudes and behaviors regarding the use of "electronic interaction." The social comparison and feedback-seeking subscale is a 10-item measure, assessing adolescents' use of social media to "seek out information regarding one's appearance, behaviors, and social status, relative to one's peers. Responses are indicated on a 5-point Likert scale (1 for Not at all true, and 5 for Extremely true). Higher scores mean worse outcomes.
12 weeks
The Social Connectedness Scale
Time Frame: 12 weeks
My secondary objectives will test within and between groups (treatment vs control) changes in social connectedness. The Social Connectedness Scale (SCS) assesses the degree to which youth feel connected to others in their social environment. The SCS is an eight-item measure. Responses are indicated on a six-point Likert scale ranging from 1 (agree) to 6 (disagree). Higher scores mean better outcomes.
12 weeks
Body-Related Shame and Guilt Scale (WEB-SG)
Time Frame: 12 weeks
My secondary objectives will test within and between groups (treatment vs control) changes in eating guilt. The WEB-SG is a 12-item scale that measures feelings of shame (six items) and guilt (six items). This study will only utilize the guilt scale. Responses will be indicated on a 5-point scale from 0 "never" to 4 "always." Higher scores mean worse outcomes.
12 weeks

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.
University of South Carolina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nkechi Okpara, MS, RDN, University of South Carolina

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.
June 9, 2022

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.
April 15, 2023

Study Completion (Anticipated)

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 15, 2023

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).
December 29, 2022

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.
March 24, 2023

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.
March 27, 2023

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.
May 9, 2023

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.
May 8, 2023

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.
May 1, 2023

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.
  • Pro00120545

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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