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

Eating Behavior Clinical Trial

— BABE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05786560
• Other study ID #: Pro00120545
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 9, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: May 2023
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: August 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge Eating
• Body Image
• Bulimia
• Disordered Eating
• Eating Behavior

Intervention

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.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 weeks
Primary	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.	12 weeks
Primary	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).	12 weeks
Primary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks