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临床试验/NCT05433415
NCT05433415进行中(未招募)不适用

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

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
120
试验地点
2
主要终点
Change from Actigraph GT3X Device at 12 and 24 weeks

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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.

结局指标

主要结局

Change from Actigraph GT3X Device at 12 and 24 weeks

时间窗: Baseline, 12 weeks, 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

时间窗: Baseline, 12 weeks, 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).

次要结局

  • 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 Physical Activity and Nutrition Self-Efficacy Scale at 12 and 24 weeks(Baseline, 12 weeks, and 24 weeks)
  • Change from Social Support Scale at 12 and 24 weeks(Baseline, 12 weeks, and 24 weeks)
  • Change from Family Assessment Device (FAD) at 12 and 24 weeks(Baseline, 12 weeks, and 24 weeks)
  • Change fron Quality of Mother Interaction 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 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 Social Support for Physical Activity at 12 and 24 weeks(Baseline, 12 weeks, and 24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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