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

Primary Purpose

Adolescent Obesity, Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Black Girls Move
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adolescent Obesity focused on measuring dyad, mothers, daughters, physical activity, nutrition, racism

Eligibility Criteria

12 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Rush University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Black Girls Move (BGM) Treatment Condition

Daughters-Only Comparison Condition (DOCC)

Arm Description

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.

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®.

Outcomes

Primary Outcome Measures

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
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).

Secondary Outcome Measures

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.
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.
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.
Change from Diet and Health Knowledge Survey at 12 and 24 weeks
A 42-item self-report measure of daughter and mother diet knowledge.
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.
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.
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.
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.
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

Full Information

First Posted
June 21, 2022
Last Updated
March 9, 2023
Sponsor
Rush University Medical Center
Collaborators
National Institutes of Health (NIH), University of Illinois at Chicago, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05433415
Brief Title
Black Girls Move Physical Activity and Improving Dietary Intake Among Black Adolescent Daughters
Official Title
Black Girls Move: A Daughter/Mother Intervention to Prevent Obesity by Increasing Physical Activity and Improving Dietary Intake Among Black Adolescent Daughters
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
Collaborators
National Institutes of Health (NIH), University of Illinois at Chicago, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Obesity, Diabetes Mellitus
Keywords
dyad, mothers, daughters, physical activity, nutrition, racism

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
384 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Black Girls Move (BGM) Treatment Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Daughters-Only Comparison Condition (DOCC)
Arm Type
Active Comparator
Arm Description
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®.
Intervention Type
Behavioral
Intervention Name(s)
Black Girls Move
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Actigraph GT3X Device at 12 and 24 weeks
Description
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
Time Frame
Baseline, 12 weeks, and 24 weeks
Title
Change from Block Kids 2004 Food Frequency Questionnaire (BKFFQ) at 12 and 24 weeks
Description
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).
Time Frame
Baseline, 12 weeks, and 24 weeks
Secondary Outcome Measure Information:
Title
Change from 3-Day Physical Activity Recall at 12 and 24 weeks moderate/vigorous physical activity per week
Description
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.
Time Frame
Baseline, 12 weeks, and 24 weeks
Title
Change from The Multidimensional Model of Black Identity - Short Form at 12 and 24 weeks
Description
A 27-item self-report measure of daughter and mother racial identity.
Time Frame
Baseline, 12 weeks, and 24 weeks
Title
Change from Child Health Behavior Knowledge Scale at 12 and 24 weeks
Description
A 9-item self-report measure of daughter and mother physical activity knowledge related to cardiovascular benefits of exercise.
Time Frame
Baseline, 12 weeks, and 24 weeks
Title
Change from Diet and Health Knowledge Survey at 12 and 24 weeks
Description
A 42-item self-report measure of daughter and mother diet knowledge.
Time Frame
Baseline, 12 weeks, and 24 weeks
Title
Change from Physical Activity and Nutrition Self-Efficacy Scale at 12 and 24 weeks
Description
An 11-item self-report measure of daughter self-efficacy for physical activity (3 items) and nutrition (8 items) behaviors.
Time Frame
Baseline, 12 weeks, and 24 weeks
Title
Change from Social Support for Physical Activity at 12 and 24 weeks
Description
An 11-item self-report measure of daughter social support for physical activity.
Time Frame
Baseline, 12 weeks, and 24 weeks
Title
Change from Social Support Scale at 12 and 24 weeks
Description
A 5-item self-report measure for daughter and mother social support for healthy eating.
Time Frame
Baseline, 12 weeks, and 24 weeks
Title
Change from Family Assessment Device (FAD) at 12 and 24 weeks
Description
A 53-item self-report measure of daughter and mother perceptions of family systems.
Time Frame
Baseline, 12 weeks, and 24 weeks
Title
Change fron Quality of Mother Interaction at 12 and 24 weeks
Description
A 14-item self-report measure of daughter perceptions of quality of communication with mother
Time Frame
Baseline, 12 weeks, and 24 weeks
Other Pre-specified Outcome Measures:
Title
Two-Item Hunger VitalSignTM
Description
A 2-item self-report questionnaire evaluating daughter and mother food insecurity in the past 12 months.
Time Frame
Baseline
Title
Change from International Physical Activity Questionnaire at 12 and 24 weeks
Description
A 27-item self-report measure of mother physical activity. Activities pertain to job (7), transportation (6), household (6), recreation (6), and sitting (2). Participants indicate frequency (days), duration (hours/minutes), and intensity (moderate to vigorous) over past 7days.
Time Frame
Baseline, 12 weeks, and 24 weeks
Title
Change from 2014 Block Food Frequency Questionnaire at 12 and 24 weeks
Description
A 127-item self-report measure of mother dietary behavior. Items similar to BKFFQ with additional items to adjust for fat, protein, carbohydrate, sugar, and whole grain content
Time Frame
Baseline, 12 weeks, and 24 weeks
Title
Change from Self-Efficacy for Walking Scale at 12 and 24 weeks
Description
A 12-item self-report measure of mother self-efficacy for walking.
Time Frame
Baseline, 12 weeks, and 24 weeks
Title
Change from Weight Efficacy Lifestyle Questionnaire at 12 and 24 weeks
Description
A 20-item self-report measure of mother dietary self-efficacy.
Time Frame
Baseline, 12 weeks, and 24 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for daughters are: 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 Inclusion criteria for mothers are: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monique Reed, PhD
Phone
3129428349
Email
monique_reed@rush.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monique Reed
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monique Reed, PhD
Phone
312-942-8349
Email
monique_reed@rush.edu
First Name & Middle Initial & Last Name & Degree
Kendra Julion
Email
kendra_c_julion@rush.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Reed, M., Wilbur, J., Tangney, C., Schoeny, M., Miller, A., Webber- Ritchey, K. (2021). Development and Feasibility of an Obesity Prevention Intervention for Black Adolescent Daughters and Their Mothers. Journal of Healthy Eating and Active Living. 1 (2) 84-97. https://doi.org/10.51250/jheal.v1i2.14
Results Reference
background
PubMed Identifier
28639382
Citation
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.
Results Reference
background
PubMed Identifier
26320909
Citation
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.
Results Reference
background

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

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