Body ImageBABENCT05786560
BABE(Body Appreciation and Better Eating), Add Some Self-compassion
A study testing BABE (Body Appreciation and Better Eating) in people with Body Image and Eating Behavior, run by University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Image, Eating Behavior, Binge Eating
- What is being tested?
- BABE (Body Appreciation and Better Eating)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2022to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female
- Black (Afro-Latina)/African American teenage girls
- Age 13 to 18 years old
- Attend high school in the United States
- Interest in nutrition
Who cannot join
- Eating disorder diagnosis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29201
About this study
Official title: 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.
- Conditions
- Body Image, Eating Behavior, Binge Eating, Nutrition, Healthy, Disordered Eating
- Being tested
- BABE (Body Appreciation and Better Eating)
- Medical subject headings
- Feeding Behavior, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BABE (Body Appreciation and Better Eating)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Body image + nutrition education +self-compassion | Experimental | 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. Receives: Behavioral: BABE (Body Appreciation and Better Eating) |
| Body image + nutrition education | Active comparator | 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. Receives: Behavioral: BABE (Body Appreciation and Better Eating) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the BABE program (sample size)
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).
Measured: 12 weeks
Feasibility of the BABE program (retention)
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.
Measured: 12 weeks
Feasibility of the BABE program (randomization)
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).
Measured: 12 weeks
Participants' acceptability of the program
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.
Measured: 12 weeks
Secondary outcomes (7)
Self-compassion for youth scale
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.
Measured: 12 weeks
Body Appreciation Scale-2
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.
Measured: 12 weeks
Mindful eating questionnaire
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.
Measured: 12 weeks
Childrens Brief Binge Eating Questionnaire
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.
Measured: 12 weeks
Motivations for Electronic Interaction Scale (MEIS)
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.
Measured: 12 weeks
The Social Connectedness Scale
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.
Measured: 12 weeks
Body-Related Shame and Guilt Scale (WEB-SG)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start9 Jun 2022
- Primary completion15 Apr 2023
- Study completion15 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body ImageStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nkechi Okpara, University of South Carolina
- Investigators
- Nkechi Okpara, MS, RDN, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786560
- Sponsor's protocol ID
- Pro00120545
- Acronym
- BABE
- Status last verified
- May 2023
- First submitted
- 29 Dec 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BABE(Body Appreciation and Better Eating), Add Some Self-compassion: a Randomized Controlled Pilot Study for Black/African American High School Teenage Girls
- ClinicalTrials.gov ID
- NCT05786560
- Acronym / sponsor ID
- BABE / Pro00120545
- Conditions
- Body Image, Eating Behavior, Binge Eating, Nutrition, Healthy, Disordered Eating
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 27 Mar 2023 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body image + nutrition education +self-compassion | Experimental | Behavioral: BABE (Body Appreciation and Better Eating)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. |
| Body image + nutrition education | Active comparator | Behavioral: BABE (Body Appreciation and Better Eating)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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Female
- Black (Afro-Latina)/African American teenage girls
- Age 13 to 18 years old
- Attend high school in the United States
- Interest in nutrition
Key exclusion criteria (2 listed)
- Eating disorder diagnosis
- Pregnancy
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 |
|---|---|---|
| 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. | Behavioural | Body image + nutrition education, Body image + nutrition education +self-compassion |
Primary outcome
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).
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.
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).
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.
7 secondary outcomes
Self-compassion for youth scale
Time frame: 12 weeks
Body Appreciation Scale-2
Time frame: 12 weeks
Mindful eating questionnaire
Time frame: 12 weeks
Childrens Brief Binge Eating Questionnaire
Time frame: 12 weeks
Motivations for Electronic Interaction Scale (MEIS)
Time frame: 12 weeks
The Social Connectedness Scale
Time frame: 12 weeks
Body-Related Shame and Guilt Scale (WEB-SG)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: Yes
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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.
Nkechi Okpara, MS, RDN principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BABE (Body Appreciation and Better Eating) in people with Body Image and Eating Behavior, run by University of South Carolina 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 May 2023. 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?
Results are not available in the source record.
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?
Feasibility of the BABE program (sample size) (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 9 May 2023.