NCT05433415

Brief Summary

Black Girls Move is a school-linked daughter/mother physical activity and dietary behavior program, with 9th and 10th grade students. This program is designed to prevent obesity in Black adolescent females and thus aligns with the NIH mission to enhance health, lengthen life, and reduce illness and disability. This project is relevant to public health because it holds the potential to reduce population health disparities impacted by structural racism.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress98%
Mar 2023May 2026

First Submitted

Initial submission to the registry

June 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

March 6, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

June 21, 2022

Last Update Submit

March 3, 2026

Conditions

Keywords

dyadmothersdaughtersphysical activitynutritionracism

Outcome Measures

Primary Outcomes (2)

  • Change from Actigraph GT3X Device at 12 and 24 weeks

    Objective measure of daughter and mother daily steps and activity counts. PA levels operationalized as moderate (1500-2600 counts/30 secs) or vigorous (\>2600 count/30 secs). Device worn for one week during waking hours

    Baseline, 12 weeks, and 24 weeks

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

    A 72-item self-report measure of daughter dietary behavior over the past week. Participants indicate frequency of consumption of food/beverages on a 6-point scale (none to every day).

    Baseline, 12 weeks, and 24 weeks

Secondary Outcomes (9)

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

    Baseline, 12 weeks, and 24 weeks

  • Change from The Multidimensional Model of Black Identity - Short Form at 12 and 24 weeks

    Baseline, 12 weeks, and 24 weeks

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

    Baseline, 12 weeks, and 24 weeks

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

    Baseline, 12 weeks, and 24 weeks

  • Change from Physical Activity and Nutrition Self-Efficacy Scale at 12 and 24 weeks

    Baseline, 12 weeks, and 24 weeks

  • +4 more secondary outcomes

Other Outcomes (5)

  • Two-Item Hunger VitalSignTM

    Baseline

  • Change from International Physical Activity Questionnaire at 12 and 24 weeks

    Baseline, 12 weeks, and 24 weeks

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

    Baseline, 12 weeks, and 24 weeks

  • +2 more other outcomes

Study Arms (2)

Black Girls Move (BGM) Treatment Condition

EXPERIMENTAL

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.

Behavioral: Black Girls Move

Daughters-Only Comparison Condition (DOCC)

ACTIVE COMPARATOR

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®.

Behavioral: Black Girls Move

Interventions

Goal setting and monitoring. All BGM daughters will self-monitor their progress towards PA goals using a PA device, Fitbit®. Additionally, BGM daughters will self-monitor their progress towards diet goals using a mobile application, Start Simple with My Plate®. Further, all BGM mothers will use Fitbit® and Start Simple with My Plate® for self monitoring, however, mothers' data will not be analyzed for this study. Since the daughter/ mother relationship is critical to achieving behavioral change, BGM mothers will utilize Fitbit® and Start Simple with My Plate® as a mechanism to communicate, problem solve and support daughters' behavioral goals.BGM is situated within the contexts of environmental, cultural, interpersonal, and developmental factors impacted by structural racism. Intentionally engaging mothers and daughters in an asset based program provides a framework for mothers to model responses to structural racism i.e. racial socialization.

Black Girls Move (BGM) Treatment ConditionDaughters-Only Comparison Condition (DOCC)

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • English speaking;
  • Black;
  • grade 9 or 10;
  • daily access to the internet outside of school and/or work through an iOS or android smart phone, tablet, or personal computer;
  • either high-normal weight (between ≥50th and \<85th percentile for age and gender) or overweight (between ≥85th and \<95th percentile for age and gender) as the purpose of this study is weight maintenance and obesity prevention in at-risk daughters rather than obesity treatment; 98 and
  • have either a poor diet, (defined as consuming \<1 vegetable or \<1 fruit per day) 99 or inadequate PA (defined as \< 60 minutes per day, 7 days per week). 99,100
  • English-speaking;
  • Black;
  • co-residing biological mother or mother-figure and legal guardian of the participating daughter;
  • the person primarily responsible for meals in the household; and
  • access to the internet through an iOS or android smart phone, tablet or personal computer. In a longitudinal study of 480 adults, 84% of adults with obesity were adolescents with high normal weight status (≥50th and \<85th percentile). National data on cell phone ownership show that 81% of Black students and 68% of Black parents own a smart phone

You may not qualify if:

  • having conditions/procedures that prevent the oral consumption of foods (e.g., gastric feeding tubes);
  • presence of physical limitations that would preclude participation in the PA activity components of the intervention;
  • altered dietary intake (e.g., pregnancy, eating or metabolic disorders except for type 1 or type 2 diabetes); and
  • at baseline physical assessment, participants screened for uncontrolled blood pressure (systolic \> 130, diastolic \>80 for daughters; and systolic \>160, diastolic \>100 for mothers) will be eligible only with a healthcare provider release.
  • participants with diagnosed type 1 or 2 diabetes will be eligible for participation only with a healthcare provider release.
  • mothers will be screened for cardiovascular disease and musculoskeletal risk factors with the 7-item Physical Activity Readiness Questionnaire. Mothers that answer 'yes' to any item on the Physical Activity Readiness Questionnaire will be eligible only with a healthcare provider release. Daughters or mothers who are asked to provide healthcare provider release will be referred to the Chicago Department of Public Health if they do not have a primary care provider. To be eligible to participate in either condition, both the daughter and her mother must be willing and eligible to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (3)

  • Reed M, Wilbur J, Tangney CC, Miller AM, Schoeny ME, Webber-Ritchey KJ. Development and Feasibility of an Obesity Prevention Intervention for Black Adolescent Daughters and Their Mothers. J Healthy Eat Act Living. 2021 Apr 1;1(2):94-107. eCollection 2021.

    PMID: 37789909BACKGROUND
  • Reed M, Julion W, McNaughton D, Wilbur J. Preferred intervention strategies to improve dietary and physical activity behaviors among African-American mothers and daughters. Public Health Nurs. 2017 Sep;34(5):461-471. doi: 10.1111/phn.12339. Epub 2017 Jun 22.

    PMID: 28639382BACKGROUND
  • Reed M, Wilbur J, Schoeny M. Parent and African American Daughter Obesity Prevention Interventions: An Integrative Review. J Health Care Poor Underserved. 2015 Aug;26(3):737-60. doi: 10.1353/hpu.2015.0103.

    PMID: 26320909BACKGROUND

MeSH Terms

Conditions

Pediatric ObesityDiabetes MellitusMotor ActivityRacism

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBehaviorPrejudiceSocial BehaviorSocial Discrimination

Study Officials

  • Monique Reed

    Rush University Medical Center

    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
SPONSOR

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 27, 2022

Study Start

March 6, 2023

Primary Completion

November 30, 2025

Study Completion (Estimated)

May 30, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations