Black Girls Move Program for Childhood Obesity

Overseen By Monique Reed, PhD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Gastric feeding tubes, Physical limitations, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to prevent obesity in Black adolescent females by engaging both daughters and their mothers in the Black Girls Move Program, which emphasizes physical activity and healthy eating. It examines whether involving mothers alongside their daughters can enhance program outcomes. Participants will be divided into two groups: one where mothers and daughters participate together, and another with daughters only. Suitable candidates include Black female students in 9th or 10th grade who have daily internet access and are at risk due to a poor diet or lack of physical activity. As an unphased study, this trial provides a unique opportunity to contribute to important research that could improve health outcomes for Black adolescent females.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have uncontrolled blood pressure or diabetes, you will need a healthcare provider's approval to participate.

What prior data suggests that the Black Girls Move Program is safe for participants?

Research has shown that the Black Girls Move program, which emphasizes exercise and healthy eating, may help prevent obesity in Black teenage girls. The program prioritizes safety. In past studies, participants generally found it easy to follow, and no serious side effects were reported. It includes planned activities and goal-setting, with both daughters and mothers participating. This approach not only aims to improve health but also strengthens family connections. Involving mothers creates a supportive environment, benefiting both emotional and physical health. While researchers continue to study the program, its design and early results suggest it is a safe choice for those interested in joining. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Black Girls Move program because it offers a unique approach to addressing childhood obesity in Black adolescent females. Unlike standard treatments that often focus solely on individual lifestyle changes, this program uses the Anti-Racist Public Health Critical Race Praxis to address the social and racial factors impacting health. By involving mothers as active participants, it also leverages family dynamics to enhance communication and support. This dual focus on sociocultural context and family involvement makes the program stand out as a promising new method for tackling childhood obesity in a holistic way.

What evidence suggests that the Black Girls Move Program is effective for preventing obesity in Black adolescent females?

Research has shown that the Black Girls Move program, one of the treatment arms in this trial, could help prevent obesity in Black adolescent girls. Similar school programs have improved physical activity and diet, both crucial for managing weight. The Black Girls Move program involves both daughters and mothers, which past participants found helpful for achieving their health goals. This teamwork can boost motivation and support, making it more effective than programs involving only daughters. Meanwhile, the Daughters-Only Comparison Condition, another arm in this trial, runs parallel to the Black Girls Move intervention and includes daughters-only group meetings. Both arms use proven methods like setting goals and tracking progress to promote healthy habits. These methods have been effective in other programs aimed at reducing obesity. ^{6 7 8 9 10}

Who Is on the Research Team?

Monique Reed

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Mothers: 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, access to the internet through an iOS or android smart phone, tablet, or personal computer

I am a Black, English-speaking girl in grade 9 or 10, with daily internet access and either a poor diet or not enough physical activity.

Exclusion Criteria

I can participate in physical activities required by the study.

Uncontrolled blood pressure at baseline physical assessment (systolic >130, diastolic >80 for daughters; systolic >160, diastolic >100 for mothers) without healthcare provider release

Altered dietary intake (e.g., pregnancy, eating or metabolic disorders except for type 1 or type 2 diabetes)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week daughter/mother physical activity and dietary behavior program, setting individualized goals and participating in structured activities.

12 weeks

12 weekly group sessions

Follow-up

Participants are monitored for changes in physical activity, dietary intake, and theoretical mechanisms of change post-intervention.

12 weeks

Assessments at baseline, post-intervention, and 3-months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Black Girls Move

Trial Overview

'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.

How Is the Trial Designed?

Group I: Black Girls Move (BGM) Treatment Condition Experimental Treatment 1 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 Control 1 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®.

Black Girls Move is already approved in United States for the following indications:

Approved in United States as Black Girls Move for:

• Obesity prevention in Black adolescent females

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

The 'Girls on the Move' trial aims to increase moderate to vigorous physical activity among 1200 urban girls aged 10-14 over 5 years, using a comprehensive school-based intervention that includes motivational counseling and after-school activity clubs.

The study will assess the effectiveness of the intervention on physical activity levels, cardiovascular fitness, body mass index, and body fat percentage, with results expected to inform strategies for maintaining physical activity in this demographic post-intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Girls on the Move" intervention protocol for increasing physical activity among low-active underserved urban girls: a group randomized trial. Robbins, LB., Pfeiffer, KA., Vermeesch, A., et al.[2022]

The health and weight management intervention for African American children, involving education on nutrition and active lifestyles, resulted in significantly improved knowledge about healthy habits compared to a control group.

Students in the intervention group maintained their BMI levels over two academic years, suggesting that the program may help prevent weight gain and reduce the risk of obesity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Weight Gain in Children Who Are School Age and African-American. Pope, M.[2022]

The GEMS trial is a randomized, controlled study involving 303 healthy African-American girls aged 8-10, aimed at reducing excessive weight gain through a 2-year family-based intervention focused on healthy eating and increased physical activity.

At baseline, participants had a mean BMI of 22 kg/m², with 41% classified as overweight, highlighting the need for effective obesity prevention strategies in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memphis Girls health Enrichment Multi-site Studies (GEMS): Phase 2: design and baseline. Klesges, RC., Obarzanek, E., Klesges, LM., et al.[2022]

In a study of 181 children aged 5 to 17 participating in a Weight Correction Programme, 65% were able to reduce their z-BMI, with 38% achieving a clinically significant reduction.

Boys had a significantly higher likelihood of reducing their z-BMI compared to girls, and older children (10 years and above) were more successful in weight reduction than younger ones, while larger waist circumference negatively impacted weight loss success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-Term Predictors for Weight Correction Success of the First Paediatric Weight Correction Programme in Children's Clinical University Hospital in Riga. Gailite, J., Apela, D., Dzīvīte-Krišāne, I., et al.[2020]

The New Moves program, aimed at improving eating behaviors and physical activity among 270 female adolescents aged 12 to 14, did not show significant changes in disordered eating behaviors or overall eating habits based on participation levels.

Factors such as body image satisfaction and BMI percentile influenced physical activity outcomes, with older girls benefiting more from the program, highlighting the need to consider individual characteristics when designing lifestyle interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of participation level and physical activity on eating behavior and disordered eating symptoms in the Brazilian version of the New Moves intervention: data from a cluster randomized controlled trial. Dunker, KLL., Alvarenga, MDS., Teixeira, PC., et al.[2022]

The adapted pediatric weight management program, iChoose, was successfully implemented in a health-disparate community, showing significant reductions in BMI z-scores immediately after the program, although these effects were not sustained after three months.

The program was developed through a collaborative process involving community partners and demonstrated high implementation fidelity, indicating that it can be effectively delivered in low-resource settings, but further efforts are needed to maintain long-term weight management outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participatory development and pilot testing of iChoose: an adaptation of an evidence-based paediatric weight management program for community implementation. Hill, JL., Zoellner, JM., You, W., et al.[2023]

Interventions aimed at preventing overweight and obesity in pre-adolescent girls can be effective, with 30 studies showing varying degrees of success, particularly in modifying nutrition and physical activity behaviors.

While many interventions demonstrated potential benefits, the long-term sustainability of these effects remains uncertain, highlighting the need for ongoing support and evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review to determine the effectiveness of interventions designed to prevent overweight and obesity in pre-adolescent girls. Kesten, JM., Griffiths, PL., Cameron, N.[2019]

The Girls Health Enrichment Multi-site Studies (GEMS) pilot-tested four different interventions aimed at preventing obesity in African-American girls, showing favorable outcomes in recruitment and behavioral change.

The study highlighted the importance of community trust and acceptability in implementing obesity prevention strategies, paving the way for future full-scale randomized trials in Phase 2 of the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 of the Girls health Enrichment Multi-site Studies (GEMS): conclusion. Kumanyika, SK., Obarzanek, E., Robinson, TN., et al.[2022]

The Butterfly Girls program is an 8-episode online intervention designed specifically for 8-10 year old African American girls, aiming to promote healthy eating and physical activity to combat obesity.

The study will involve 390 parent/child pairs and will measure changes in body mass index, fruit and vegetable consumption, and physical activity over time, assessing the program's effectiveness in reducing obesity risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Butterfly Girls; promoting healthy diet and physical activity to young African American girls online: rationale and design. Thompson, D., Mahabir, R., Bhatt, R., et al.[2022]

The New Moves program, a school-based obesity prevention initiative for adolescent girls, was well-received, showing high satisfaction among participants, parents, and school staff, indicating its feasibility for implementation.

While participants reported positive changes in physical activity and self-image, the program did not produce statistically significant differences in most health outcomes compared to control schools, suggesting the need for further evaluation and enhancement of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Moves: a school-based obesity prevention program for adolescent girls. Neumark-Sztainer, D., Story, M., Hannan, PJ., et al.[2022]

The Stanford GEMS trial is a randomized controlled study involving 261 low-income African-American girls aged 8 to 10, aimed at preventing obesity through a culturally-tailored after-school dance program and a family-based intervention to reduce screen time.

Baseline findings indicate that participants have a high prevalence of obesity risk factors, with a mean BMI at the 74th percentile and significant levels of screen media use, highlighting the need for targeted obesity prevention strategies in this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stanford GEMS phase 2 obesity prevention trial for low-income African-American girls: design and sample baseline characteristics. Robinson, TN., Kraemer, HC., Matheson, DM., et al.[2022]

A study involving 210 African-American girls aged 8-10 established that weight concern measures, including the Overconcern with Weight and Shape (OWS) scale, showed good internal consistency (0.71 to 0.84) and promising validity in relation to body mass index (BMI) and body fat percentage (PBF).

While the measures demonstrated reasonable reliability, the test-retest reliability was only moderate (0.45-0.58), indicating a need for further refinement and validation of these tools for assessing weight concerns in this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement characteristics of weight concern and dieting measures in 8-10-year-old African-American girls from GEMS pilot studies. Sherwood, NE., Beech, BM., Klesges, LM., et al.[2022]

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