- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05786560
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
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
Phase
- 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
- Name: Nkechi Okpara, MS, RDN
- Phone Number: 6098583972
- Email: Nokpara@email.sc.edu
Study Locations
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South Carolina
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Columbia, South Carolina, United States, 29201
- University of South Carolina
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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
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 |
Intervention / Treatment |
---|---|
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.
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of the BABE program (sample size)
Time Frame: 12 weeks
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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).
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12 weeks
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Feasibility of the BABE program (randomization)
Time Frame: 12 weeks
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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).
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12 weeks
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Feasibility of the BABE program (retention)
Time Frame: 12 weeks
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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.
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12 weeks
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Participants' acceptability of the program
Time Frame: 12 weeks
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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.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-compassion for youth scale
Time Frame: 12 weeks
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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.
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12 weeks
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Body Appreciation Scale-2
Time Frame: 12 weeks
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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.
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12 weeks
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Mindful eating questionnaire
Time Frame: 12 weeks
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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.
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12 weeks
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Childrens Brief Binge Eating Questionnaire
Time Frame: 12 weeks
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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.
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12 weeks
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Motivations for Electronic Interaction Scale (MEIS)
Time Frame: 12 weeks
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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.
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12 weeks
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The Social Connectedness Scale
Time Frame: 12 weeks
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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.
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12 weeks
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Body-Related Shame and Guilt Scale (WEB-SG)
Time Frame: 12 weeks
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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.
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
June 9, 2022
Primary Completion (Actual)
April 15, 2023
Study Completion (Anticipated)
August 15, 2023
Study Registration Dates
First Submitted
December 29, 2022
First Submitted That Met QC Criteria
March 24, 2023
First Posted (Actual)
March 27, 2023
Study Record Updates
Last Update Posted (Actual)
May 9, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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