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

Sponsor
Rush University Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05433415
Collaborator
National Institutes of Health (NIH) (NIH), University of Illinois at Chicago (Other)
192
2
30

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Black Girls Move
Phase 1/Phase 2

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, we developed Black Girls Move, a school-based obesity prevention intervention that addresses these limitations in the extant literature. We 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. We will recruit 24 daughter/mother dyads at each of 8 schools for a total sample size of 192 daughter/mother dyads. 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. We recognize that there are potential validity threats associated with within school student randomization. We 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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
192 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Black Girls Move: A Daughter/Mother Intervention to Prevent Obesity by Increasing Physical Activity and Improving Dietary Intake Among Black Adolescent Daughters
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Black Girls Move (BGM) Treatment Condition

BGM is guided by the Anti-Racist PHCRP 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
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, Foodstand®. Further, all BGM mothers will use Fitbit® and Foodstand® 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 Foodstand® 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.

Active Comparator: Daughters-Only Comparison Condition (DOCC)

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 PHCRP and SCT 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 Foodstand®.

Behavioral: Black Girls Move
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, Foodstand®. Further, all BGM mothers will use Fitbit® and Foodstand® 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 Foodstand® 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.

Outcome Measures

Primary Outcome Measures

  1. number of steps per day [6 months]

  2. diet quality [6 months]

    Healthy Eating Index 2010

Secondary Outcome Measures

  1. minutes of moderate/vigorous physical activity per week moderate/vigorous physical activity per week [6 months]

  2. self-report physical activity [6 months]

  3. consumption of sugar sweetened beverages [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 18 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • (a) English speaking; (b) Black; (c) grade 9 or 10; (d) daily access to the internet outside of school and/or work through an iOS or android smartphone, tablet, or personal computer; (e) 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 (f) 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 Inclusion criteria for mothers are (a) English-speaking; (b) Black; (c) co-residing biological mother or mother-figure and legal guardian of the participating daughter; (d) the person primarily responsible for meals in the household; and (e) access to the internet through an iOS or android smartphone, 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 smartphone
Exclusion Criteria:
  • The exclusion criteria for both daughters and mothers includes: (a) having conditions/procedures that prevent the oral consumption of foods (e.g., gastric feeding tubes); (b) presence of physical limitations that would preclude participation in the PA activity components of the intervention; (c) altered dietary intake (e.g., pregnancy, eating or metabolic disorders except for type 1 or type 2 diabetes); and (d) 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. In addition, (e) participants with diagnosed type 1 or 2 diabetes will be eligible for participation only with a healthcare provider release. Further, (f) mothers will be screened for CVD and musculoskeletal risk factors with the 7-item Physical Activity Readiness Questionnaire. 103 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Rush University Medical Center
  • National Institutes of Health (NIH)
  • University of Illinois at Chicago

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT05433415
Other Study ID Numbers:
  • R01DK132698
First Posted:
Jun 27, 2022
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rush University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2022