NCT05786560

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

10 months

First QC Date

December 29, 2022

Last Update Submit

May 8, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (7)

  • Self-compassion for youth scale

    12 weeks

  • Body Appreciation Scale-2

    12 weeks

  • Mindful eating questionnaire

    12 weeks

  • Childrens Brief Binge Eating Questionnaire

    12 weeks

  • Motivations for Electronic Interaction Scale (MEIS)

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: BABE (Body Appreciation and Better Eating)

Interventions

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.

Body image + nutrition educationBody image + nutrition education +self-compassion

Eligibility Criteria

Age13 Years - 18 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female
  • Black (Afro-Latina)/African American teenage girls
  • Age 13 to 18 years old
  • Attend high school in the United States
  • Interest in nutrition

You may not qualify if:

  • Eating disorder diagnosis
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29201, United States

Location

MeSH Terms

Conditions

Feeding BehaviorBulimia

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorHyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nkechi Okpara, MS, RDN

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 29, 2022

First Posted

March 27, 2023

Study Start

June 9, 2022

Primary Completion

April 15, 2023

Study Completion

August 15, 2023

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations