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

Primary Purpose

Body Image, Eating Behavior, Binge Eating

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BABE (Body Appreciation and Better Eating)
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Body Image

Eligibility Criteria

13 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Body image + nutrition education +self-compassion

Body image + nutrition education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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.
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).
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
December 29, 2022
Last Updated
May 8, 2023
Sponsor
University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT05786560
Brief Title
BABE(Body Appreciation and Better Eating), Add Some Self-compassion
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 9, 2022 (Actual)
Primary Completion Date
April 15, 2023 (Actual)
Study Completion Date
August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Image, Eating Behavior, Binge Eating, Nutrition, Healthy, Disordered Eating

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Body image + nutrition education +self-compassion
Arm Type
Experimental
Arm Description
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.
Arm Title
Body image + nutrition education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BABE (Body Appreciation and Better Eating)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of the BABE program (sample size)
Description
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).
Time Frame
12 weeks
Title
Feasibility of the BABE program (retention)
Description
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.
Time Frame
12 weeks
Title
Feasibility of the BABE program (randomization)
Description
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).
Time Frame
12 weeks
Title
Participants' acceptability of the program
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Self-compassion for youth scale
Description
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.
Time Frame
12 weeks
Title
Body Appreciation Scale-2
Description
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.
Time Frame
12 weeks
Title
Mindful eating questionnaire
Description
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.
Time Frame
12 weeks
Title
Childrens Brief Binge Eating Questionnaire
Description
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.
Time Frame
12 weeks
Title
Motivations for Electronic Interaction Scale (MEIS)
Description
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.
Time Frame
12 weeks
Title
The Social Connectedness Scale
Description
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.
Time Frame
12 weeks
Title
Body-Related Shame and Guilt Scale (WEB-SG)
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nkechi Okpara, MS, RDN
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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