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Adolescent ObesityNCT05433415

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

A study testing Black Girls Move in people with Adolescent Obesity and Diabetes Mellitus, run by Rush University Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 18 years, women onlyHealthy volunteers can take part
Conditions the study is for
Adolescent Obesity, Diabetes Mellitus
What is being tested?
Black Girls Move
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
6 Mar 2023to 30 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • The exclusion criteria for both daughters and mothers includes:
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Rush University Medical Center

    Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Black Girls Move: A Daughter/Mother Intervention to Prevent Obesity by Increasing Physical Activity and Improving Dietary Intake Among Black Adolescent Daughters

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.

Read the detailed description

Black female adolescents are at increased risk for obesity-related morbidity and mortality as adults compared to non-Hispanic White female adolescents. Interventions to prevent obesity in Black female adolescents that leverage the relationship of the daughter/mother dyad have received limited attention. Studies that do include mothers tend to use theoretical frameworks that do not explicitly build on this important family relationship and have not included mothers' active participation. Additionally, these studies do not include girls over the age of 12. In response, the investigators developed Black Girls Move, a school-based obesity prevention intervention that addresses these limitations in the extant literature. The investigators conducted focus groups with daughter/mother dyads to identify practical, cultural, and age-appropriate strategies for improving physical activity (PA) and dietary behaviors in Black adolescent daughters (grades 9-10, ages 14-17). Black Girls Move consists of 12 weekly group sessions of daughter/mother dyads in which participants set individualized PA and dietary goals. Black Girls Move incorporates content and processes derived from asset-based anti-racist Public Health Critical Race Praxis, Family Systems Theory, and Social Cognitive Theory. Specific aims are to determine the efficacy of Black Girls Move compared to daughters-only comparison condition on change in PA and dietary intake, and the impact of Black Girls Move compared to daughters-only on theoretical mechanisms of change (racial identity, daughter/mother relationship, social cognitions) assessed by self-report measures.

The design is a 12-week pre-test/post-test, randomized controlled trial. The investigators will recruit 24 daughter/mother dyads at each of 8 schools for a total sample size of 192 daughter/mother dyads (total 384 participants). Within school, each dyad will be randomized to either Black Girls Move or daughters-only comparison condition (12 per condition). All daughters and all mothers (Black Girls Move daughter/mother dyads and daughters-only comparison condition daughter/mother dyads) complete assessments (e.g., PA, diet, family measures) at baseline, post-intervention, and 3-months post-intervention. The investigators recognize that there are potential validity threats associated with within school student randomization. The investigators will collect data to assess the degree to which these potential threats are pertinent. The long-term goal of this research is to decrease disparities in obesity and associated comorbidities in Black women. The findings may inform future large scale R01 studies of BGM in Black daughter/mother dyads

Being tested
Black Girls Move
Keywords
dyad, mothers, daughters, physical activity, nutrition, racism
Medical subject headings
Pediatric Obesity, Diabetes Mellitus, Motor Activity, Racism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Black Girls MoveBehavioural

    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.

Study groups in NCT05433415
Study groupRoleWhat they receive
Black Girls Move (BGM) Treatment ConditionExperimentalBGM 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.
Receives: Behavioral: Black Girls Move
Daughters-Only Comparison Condition (DOCC)Active comparatorThe 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®.
Receives: Behavioral: Black Girls Move

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline, 12 weeks, and 24 weeks

  2. 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).

    Measured: Baseline, 12 weeks, and 24 weeks

Secondary outcomes (9)
  1. Change from 3-Day Physical Activity Recall at 12 and 24 weeks moderate/vigorous physical activity per week

    A 59-item self-report measure of daughter physical activity. Participants recall 59 physical activity activities in the past 3 days. Each day divided into 34, 30-minute blocks from 7 am to midnight. Activities rated as light, moderate, hard, or very hard.

    Measured: Baseline, 12 weeks, and 24 weeks

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

    A 27-item self-report measure of daughter and mother racial identity.

    Measured: Baseline, 12 weeks, and 24 weeks

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

    A 9-item self-report measure of daughter and mother physical activity knowledge related to cardiovascular benefits of exercise.

    Measured: Baseline, 12 weeks, and 24 weeks

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

    A 42-item self-report measure of daughter and mother diet knowledge.

    Measured: Baseline, 12 weeks, and 24 weeks

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

    An 11-item self-report measure of daughter self-efficacy for physical activity (3 items) and nutrition (8 items) behaviors.

    Measured: Baseline, 12 weeks, and 24 weeks

  6. Change from Social Support for Physical Activity at 12 and 24 weeks

    An 11-item self-report measure of daughter social support for physical activity.

    Measured: Baseline, 12 weeks, and 24 weeks

  7. Change from Social Support Scale at 12 and 24 weeks

    A 5-item self-report measure for daughter and mother social support for healthy eating.

    Measured: Baseline, 12 weeks, and 24 weeks

  8. Change from Family Assessment Device (FAD) at 12 and 24 weeks

    A 53-item self-report measure of daughter and mother perceptions of family systems.

    Measured: Baseline, 12 weeks, and 24 weeks

  9. Change fron Quality of Mother Interaction at 12 and 24 weeks

    A 14-item self-report measure of daughter perceptions of quality of communication with mother

    Measured: Baseline, 12 weeks, and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2022
  2. Study start6 Mar 2023
  3. Primary completion30 Nov 2025
  4. Study completion30 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05433415
Sponsor's protocol ID
R01DK132698
Other IDs
R01DK132698
Status last verified
Mar 2026
First submitted
21 Jun 2022
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37789909
  • 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.

    PubMed 28639382
  • 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.

    PubMed 26320909

Questions about this trial

What is this clinical trial studying?

A study testing Black Girls Move in people with Adolescent Obesity and Diabetes Mellitus, run by Rush University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Actigraph GT3X Device at 12 and 24 weeks (time frame: Baseline, 12 weeks, and 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05433415, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

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