San Diego State University Research Foundation
San Diego, California, 92123, United States
NCT Number: NCT04736030
Regular physical activity (PA) contributes to reduced risk of obesity, chronic disease, cardiovascular disease, and cancer, and can improve emotional and mental health, learning, productivity, and social skills. Latina girls are less likely to meet guidelines for moderate-to-vigorous physical activity (MVPA) than non-Hispanic white girls; factors that contribute to low PA rates among Latina girls include sex role expectations, low PA competency, few active role models, lack of parental support for PA, and lack of access to resources.
The goal of this study, informed by social cognitive theory and family systems theory, is to design, implement, and evaluate an intervention promoting physical activity among Latina pre-adolescent girls (aged 8-11) and their mothers. The intervention is based on evidence suggesting that parent-child interventions and single-sex interventions are more effective at improving PA. Mothers and daughters will participate in a 12-week virtual intervention where they will engage in weekly 1.5-hour sessions that incorporate didactic teaching, skill-building, interactive discussions, and PA. Each session will include at least 30 minutes of PA. The intervention will be compared with a control condition that will receive an abbreviated version of the intervention following completion of all measurement points.
Ninety mother-daughter dyads will be randomly assigned to the intervention or the wait-list control condition. The primary aim is to determine whether the intervention will increase MVPA among Latina girls in the intervention condition relative to those in the control condition. The investigators hypothesize that daughters participating in Conmigo will have higher minutes of MVPA at M2 and M3 compared to girls in the delayed treatment control condition.
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Notify Me8 year–65 year
Female
Interventional
Not applicable
San Diego, California, 92123, United States
This two-group randomized controlled trial integrates evidence-based strategies for promoting moderate-to-vigorous physical activity (MVPA) among Latina women and girls to design and deliver a mother-daughter intervention to increase girls' MVPA.
Mothers are instrumental in promoting healthy behaviors to their daughters. Specifically, mothers' PA and PA parenting practices influence their daughters' PA. Mothers can create and support PA opportunities, reduce access to sedentary activities, model PA, and reinforce daughters to be physically active. Other family level factors like parent-child communication positively predicts PA for girls. Family influences are generally hierarchical, in that influence often flows from mothers to daughters. However, parents are not parenting in isolation, but in response to children's traits and behaviors, as well as other social factors. Thus, children play an important role in shaping PA parenting practices and mothers' PA through encouragement and support. Understanding daughters' and mothers' PA and other family factors from multiple perspectives will extend our understanding of the bidirectional nature of parent-child relationships that may hinder or facilitate behavioral trajectories of PA.
The study will recruit 90 pairs of mothers and their preadolescent daughters through partnerships with schools and diverse community organizations that serve Latinos. Each pair will be randomly assigned to a 12-week Conmigo PA intervention (n=45 dyads) or to a 4-week abbreviated intervention following completion of M3 assessment (control) (n=45 dyads). The full and abbreviated (control) interventions will include PA and PA counseling, as well as parenting discussion. The study will examine the efficacy of the intervention in increasing daughters' and mothers' PA at 12 and 24 weeks after baseline measurements. Secondary outcomes include mother-daughter communication and PA parenting practices at 12 weeks (M2), and 24 weeks (M3) using protocols and instruments developed in the formative phase. Participants in the control condition will participate in an abbreviated (4 week) version of the intervention after the M3 assessment. After the 12-week intervention, the investigators will conduct focus groups with intervention condition participants, stratified by daughters who met the PA guidelines and those who did not, to identify potential moderators (e.g., BMI, perceived barriers to PA) and mediators (e.g., mother-daughter communication, PA support, PA parenting practices) that may explain and influence program impact.
The investigators hypothesize that daughters participating in Conmigo will have higher minutes of MVPA at M2 and M3 compared to girls in the delayed treatment control condition. They also hypothesize that mothers in the intervention will increase minutes of MVPA and demonstrate improved use of PA parenting practices and mother-daughter communication compared to the control condition.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Twelve weekly sessions will be led by Ms. Schneider and Ms. Montañez supported by Drs. Arredondo and Ayala and student research assistants. Mothers and daughters will participate in weekly virtual 1.5-hour sessions that include didactic teaching, skill building (including PA parenting and communication skills training), interactive discussions, PA, and homework review (homework examples: 30-min walks, practicing communication strategies). Mothers and daughters will attend sessions together, with 10-12 mother-daughter dyads participating in each series. Sessions 2-12 will include at least 30 min PA. Sessions will discuss strategies to engage in PA outside the sessions (goal of 60-min MVPA daily).
Other names: Conmigo
Time frame: 3 months
Investigators will assess daughters' MVPA at baseline and 3 months using the ActiGraph wGT3X accelerometer worn for 7 days: MVPA=average min MVPA per valid day (minimum 10 h/day of data monitoring for at least 3 days) using standard cutoffs. Investigators will compare PA at 3 months to PA at baseline to assess change.
Time frame: 3 months
Investigators will also assess daughters' self-reported PA using the Family Life, Activity, Sun, Health and Eating (FLASHE) adolescent physical activity survey instrument. Investigators will compare PA at 3 months to PA at baseline to assess change. Daughters complete ONE of the two scales: Version A (8 items) if not currently attending school (remote school due to COVID, homeschool, or summer break), and version B (11 items) if attending in person school. Each item in version A and B scales is scored in units on a scale from 0 to 4. The average score is calculated using the total score divided by the number of items. Scores range from 0-4 with higher scores representing a better outcome (i.e., increased self-reported moderate to vigorous physical activity).
Time frame: 6 months
Investigators will assess daughters' self-reported PA using the Family Life, Activity, Sun, Health and Eating (FLASHE) adolescent physical activity survey instrument. Investigators will compare PA at 6 months to PA at baseline and 3 months to assess sustainment of MVPA three months after the intervention has ended. Daughters complete ONE of the two scales: Version A (8 items) if not currently attending school (remote school due to COVID, homeschool, or summer break), and version B (11 items) if attending in person school. Each item in version A and B scales is scored in units on a scale from 0 to 4. The average score is calculated using the total score divided by the number of items. Scores range from 0-4 with higher scores representing a better outcome (i.e., increased self-reported moderate to vigorous physical activity).
Time frame: 3 months
Investigators will assess mothers' MVPA at baseline and 3 months using the ActiGraph wGT3X accelerometer worn for 7 days: MVPA=average min MVPA per valid day (minimum 10 h/day of data monitoring for at least 3 days) using standard cutoffs. Investigators will compare PA at 3 months to PA at baseline to assess change.
Time frame: 3 months
Mothers' self-reported physical activity (PA) was assessed using the Global Physical Activity Questionnaire (GPAQ). Investigators compared PA at 3 months to baseline to assess changes. Moderate-to-vigorous physical activity (MVPA) was measured through leisure-time activities, including moderate activities (e.g., brisk walking, cycling) and vigorous-intensity activities (e.g., running, heavy lifting). The total number of days per week and minutes per day spent in these activities were summed to calculate total MVPA minutes per week. Scores may range from 0 to 600 minutes per week. A recommendation of 150 minutes of moderate-to-vigorous PA (MVPA) per week is recommended, with minimum guidelines of 150 minutes of moderate or 75 minutes of vigorous activity per week.
Time frame: 6 months
Investigators will assess mothers' self-reported physical activity (PA) using the Global Physical Activity Questionnaire (GPAQ). PA will be compared at baseline, 3 months, and 6 months to assess the sustainment of moderate-to-vigorous physical activity (MVPA) three months after the intervention has ended. MVPA was measured through leisure-time activities, including moderate activities (e.g., brisk walking, cycling) and vigorous-intensity activities (e.g., running, heavy lifting). The total number of days per week and minutes per day spent in these activities were summed to calculate total MVPA minutes per week. Scores may range from 0 to 600 minutes per week. A recommendation of 150 minutes of moderate-to-vigorous PA (MVPA) per week is recommended, with minimum guidelines of 150 minutes of moderate or 75 minutes of vigorous activity per week.
Time frame: baseline, 3 months, 6 months
Mother-daughter communication was assessed using the Parent-Adolescent Communication Scale (PACS) (Barnes & Olsen, 1985), completed by mothers. The PACS consists of 20 items, scored on a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree). The total score ranges from 20 to 100, with higher scores reflecting better communication. The PACS has two subscales: Open Family Communication and Problems in Family Communication. Responses to the "Problems in Family Communication" subscale are reverse-coded so that higher scores across both subscales indicate better communication quality. The total score is the sum of responses, and higher subscale scores indicate more positive communication or less communication problems.
Time frame: baseline, 3 months, 6 months
Mothers' parenting strategies were assessed using the Parenting Strategies for Eating & Activity Scale (PEAS) (Larios et al., 2009), completed by mothers. The PEAS consists of items rated on a 5-point Likert scale, with response options ranging from 1 (disagree/never) to 5 (agree/always). Three subscales were administered to capture the following domains: Limit Setting (6-items), Monitoring (7-items), and Reinforcement (2-items). We produced a total score for each subscale by summing the response items. Possible score ranges: Limit setting, 6 (minimum) to 30 (maximum); Monitoring, 7 (minimum) to 35 (maximum); Reinforcement, 2 (minimum) to 10 (maximum). For each domain, subscale scores were standardized by dividing each participant's total subscale score by the number of items in that subscale. Higher scores on each subscale indicate a greater frequency or level of the respective parenting practice (i.e., more frequent use of limit setting, monitoring, or reinforcement strategies.)
San Diego State University
Other
A Mother-daughter Intervention to Promote Physical Activity
Acronym: Conmigo
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