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Behavioral Intervention

Black Girls Move Program for Childhood Obesity

N/A

Recruiting

Led By Monique Reed

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 weeks, and 24 weeks

Awards & highlights

Study Summary

This trial program works to reduce obesity in young Black girls and lessen health disparities caused by systemic racism. #BlackGirlsMove

Who is the study for?

This trial is for Black adolescent girls in grades 9 or 10, who are at high-normal weight or overweight and have a poor diet or inadequate physical activity. They must have daily internet access and be English-speaking with a mother-figure willing to participate. Exclusions include physical limitations, uncontrolled blood pressure without healthcare provider release, and certain dietary conditions.Check my eligibility

What is being tested?

'Black Girls Move' is a program linking schools with mothers/daughters to encourage physical activity and improve diets among Black teenage girls. It aims to prevent obesity by promoting healthful behaviors through accessible technology like smartphones.See study design

What are the potential side effects?

Since the intervention involves increased physical activity and dietary changes rather than medication, side effects may include typical exercise-related discomforts such as muscle soreness or fatigue but should not involve severe adverse reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 weeks, and 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 weeks, and 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Actigraph GT3X Device at 12 and 24 weeks

Change from Block Kids 2004 Food Frequency Questionnaire (BKFFQ) at 12 and 24 weeks

Secondary outcome measures

Change from 3-Day Physical Activity Recall at 12 and 24 weeks moderate/vigorous physical activity per week

Change from Child Health Behavior Knowledge Scale at 12 and 24 weeks

Change from Diet and Health Knowledge Survey at 12 and 24 weeks

+6 more

Other outcome measures

Change from 2014 Block Food Frequency Questionnaire at 12 and 24 weeks

Change from International Physical Activity Questionnaire at 12 and 24 weeks

Change from Self-Efficacy for Walking Scale at 12 and 24 weeks

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Black Girls Move (BGM) Treatment ConditionExperimental Treatment1 Intervention

BGM is guided by the Anti-Racist Public Health Critical Race Praxis with adaptive mechanisms to support Black adolescent females as they navigate a racist society. The BGM treatment condition will include mothers as active participants in all components of the weekly, 12-session intervention to test the impact of actively leveraging the daughter/mother relationship . Participants in our prior research endorsed the importance of daughters and mothers actively engaging in group meetings together on weekends. Participants set PA and diet goals and self-monitor goal attainment. Dyads participate in structured activities designed to facilitate communication, problem solving, role assignment, and relationship quality. Dyads use a variety of videos, role play, discussion, and activities to achieve session outcomes. The sessions are led by trained facilitators who follow a standardized facilitator manual.

Group II: Daughters-Only Comparison Condition (DOCC)Active Control1 Intervention

The DOCC runs parallel to the BGM intervention and includes daughters-only group meetings. The DOCC incorporates all components of BGM except Family Systems Theory strategies. Daughters in DOCC will receive PA and diet behavior content based on Anti-Racist Public Health Critical Race Praxis and Social Cognitive Theory with daughter-only group activities. DOCC facilitators will lead group meetings and discussions. All DOCC daughters will self-monitor their progress towards PA goals using Fitbit® and progress towards diet goals using Start Simple with My Plate®.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,117 Total Patients Enrolled

3 Trials studying Diabetes

166 Patients Enrolled for Diabetes

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,208 Total Patients Enrolled

107 Trials studying Diabetes

138,663 Patients Enrolled for Diabetes

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,492 Total Patients Enrolled

25 Trials studying Diabetes

64,177 Patients Enrolled for Diabetes

Media Library

Black Girls Move (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05433415 — N/A

Diabetes Research Study Groups: Black Girls Move (BGM) Treatment Condition, Daughters-Only Comparison Condition (DOCC)

Diabetes Clinical Trial 2023: Black Girls Move Highlights & Side Effects. Trial Name: NCT05433415 — N/A

Black Girls Move (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05433415 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial accept participants aged sixty or above?

"This experiment seeks to enrol participants within the age range of 12 and 18 years old."

Answered by AI

Is this research initiative enrolling participants at the present time?

"Affirmative. According to clinicaltrials.gov, this medical research is presently recruiting participants. It was initially posted on March 6th 2023 and has since been amended as recently as the 9th of that same month. 384 individuals need to be identified from 1 main location for the study's completion."

Answered by AI

How many individuals have enrolled in this therapeutical experiment?

"Affirmative. Information hosted on clinicaltrials.gov indicates that this research is actively recruiting, having been posted on March 6th 2023 and revised most recently on March 9th 2023. The trial requires 384 patients to be recruited from a single site."

Answered by AI

To whom is this study open for enrollment?

"This clinical trial is currently recruiting 384 minors between the ages of 12 and 18 who have been diagnosed with diabetes. All participants must be English speakers, identify as Black, in grade 9 or 10, possess a personal device granting them access to the internet beyond school hours (such as an iPhone or Android), have either high-normal weight status or are overweight but not obese due to this study's aim being weight management rather than obesity treatment, consume less than one fruit/vegetable per day OR participate in fewer than 60 minutes of physical activity over seven days weekly. Furthermore, these individuals must reside near their biological mother or guardian that holds primary"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Black Girls Move Physical Activity and Improving Dietary Intake Among Black Adolescent Daughters

2023. "Black Girls Move Physical Activity and Improving Dietary Intake Among Black Adolescent Daughters". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05433415.