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Clinical Trials/NCT05786560
NCT05786560Active, not recruitingNot Applicable

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

University of South Carolina2 sites in 1 country13 target enrollmentStarted: June 9, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
13
Locations
2
Primary Endpoint
Feasibility of the BABE program (retention)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
13 Years to 18 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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.

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).

Secondary Outcomes

  • Body Appreciation Scale-2(12 weeks)
  • Mindful eating questionnaire(12 weeks)
  • Motivations for Electronic Interaction Scale (MEIS)(12 weeks)
  • Self-compassion for youth scale(12 weeks)
  • The Social Connectedness Scale(12 weeks)
  • Body-Related Shame and Guilt Scale (WEB-SG)(12 weeks)
  • Childrens Brief Binge Eating Questionnaire(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nkechi Okpara

Principal Investigator

University of South Carolina

Study Sites (2)

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