A Multi-level Mother-daughter Physical Activity Intervention for Pre- Adolescent Latinas
- Conditions
- Physical ActivityFamily CommunicationParenting Behavior
- Registration Number
- NCT07088406
- Lead Sponsor
- San Diego State University
- Brief Summary
The goal of this Cluster Randomized Control Trial (RCT) is to learn if the mother-daughter intervention titled "Conmigo" can increase Latina preadolescents' physical activity (PA). The main objectives of the study are:
* To test the effectiveness of Conmigo on daughters' Moderate-to-Vigorous level PA (MVPA) over time
* To evaluate individual (e.g. mothers' MVPA) and family level (e.g. mother-daughter communication) mechanisms of change and their bidirectional effects
Researchers will compare the 10-week physical activity promotion intervention to a 10-week parallel intervention with emphasis on another health behavior (dietary intake) to see if there are differences in MVPA levels. We will enroll 216 Latina mother-daughter pairs at 18 elementary schools; each school will randomly receive the PA intervention or the control group program.
Mothers and daughters will attend 10 weekly sessions (2 hours each) at their elementary school, led by YMCA staff. Informed by social cognitive theory and family systems theory, the PA intervention sessions target family-level correlates of physical activity such as PA promotion parenting strategies (monitoring, role-modeling, etc.) and mother-daughter communication. Participants in the intervention group engage in weekly PA during sessions, discuss different topics each week, and set goals and receive PA homework during the week.
The investigators hypothesize that daughters participating in Conmigo will have higher minutes of device-assessed MVPA at M2 (post program), M3 (6 months post program), and M4 (12-months post program) compared to girls in the control condition.
- Detailed Description
Fewer Latina girls in the United States (US) meet current physical activity (PA) guidelines, especially those from lower-income and less-acculturated backgrounds-contributing to long-standing health disparities. The pre-pubertal phase (ages 8-11) represents a critical window for PA interventions to prevent the sharp decline in activity levels that typically occurs during adolescence.
To address this need, we will conduct a two-arm cluster RCT in 18 schools serving Latina girls to evaluate Conmigo, a multilevel, mother-daughter PA intervention. This trial builds on prior formative work and a successful R21 pilot feasibility study, which demonstrated promising increases in moderate-to-vigorous physical activity (MVPA) among Latina mother-daughter dyads following a 10-week intervention.
The current study will recruit and randomize 216 mother-daughter dyads (girls aged 8-11) to either the 10-week Conmigo intervention or an attention-control program of similar duration and structure focused on dietary intake. Both programs will be delivered by trained YMCA staff in partnership with participating schools. Using a Hybrid Type 1 effectiveness-implementation design, we will assess both the effectiveness of the intervention and key implementation outcomes to inform future scale-up.
At the individual level, girls will participate in PA sessions and learn behavioral strategies to support daily PA habits. At the family level, mothers will also attend the intervention sessions and receive additional instruction focused on PA parenting practices and strengthening mother-daughter communication. Mothers are critical to shaping their daughters' PA through modeling, creating active opportunities, limiting sedentary behaviors, and providing encouragement and support. Importantly, parent-child influences are bidirectional meaning that daughters also shape parenting practices and mothers' own PA behaviors through their needs and feedback.
Girls' PA will be objectively measured using accelerometer devices worn by mothers and daughters at baseline, 3, 9, and 15 months. Secondary outcomes include PA parenting practices and mother-daughter communication, as well as mothers' PA. Focus groups and interviews with participants, school personnel, YMCA staff, and community partners will identify facilitators and barriers to implementation, mechanisms of change, and strategies for wider dissemination.
Specific Aims are to:
1. Test the effectiveness of Conmigo in increasing girls' MVPA over time;
2. Examine individual (e.g., mothers' MVPA) and family-level (e.g., communication, parenting practices) mechanisms and their bidirectional influences on behavior change;
3. Use qualitative and quantitative methods to evaluate implementation outcomes, including feasibility, fidelity, and scalability across community settings.
By partnering with 9 YMCAs and 18 schools, Conmigo aims to strengthen community capacity to deliver culturally tailored, evidence-based PA interventions. This work addresses critical gaps in the literature by focusing on Latina mother-daughter dyads, incorporating objective outcome measures and long-term follow-up, and advancing implementation science within community health promotion efforts.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 432
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in daughters' objective PA From enrollment to 3 months, 9 months, and 15 months Change in daughters' accelerometer-assessed minutes per day of moderate-to-vigorous physical activity (MVPA); worn for at least four 10+ hour days.
- Secondary Outcome Measures
Name Time Method Change in Mother-daughter communication From enrollment to 3 months, 9 months, and 15 months Completed by Mothers; assessed by Parent Adolescent Communication Scale (PACS) -Open Family Communication Domain. 10 items on a 5-point likert scale of strongly disagree to strongly agree. Sum total score ranges from 10-50, with 50 representing more open (better) mother-daughter communication.
Change in Physical Activity Parenting Strategies From enrollment to 3 months, 9 months, and 15 months Completed by mothers; assessed with two domains (Nondirective support and Guided Choice) of the Physical Activity Parenting Practices (PAPP) scale which assesses mothers' use of parenting strategies that promote physical activity (PA) among 5-12 year old children. Nondirective support is a 10-item scale; guided choice is a short-version 4-item scale. Participants respond on a 5-point likert scale of frequency which is scored 0-4 per item and sum totaled. Nondirective support subscores range from 0-40; Guided choice subscores range from 0-16. The total combined score from both domains ranges from 0-56 with a higher score meaning more frequent use of PA-promoting parenting strategies.
Change in Daughters' Dietary Intake From enrollment to 3 months Completed by daughters (with mother's assistance); Block Yesterday food screener. This screener assesses children's intake by food group; the focus is on intake of fruit and fruit juices, vegetables, potatoes, whole grains, meat/poultry/fish, dairy, legumes, saturated fat, "added sugars", glycemic load and glycemic index. A secondary analysis produces estimates for intake of sugary beverages (both kcal and frequency). Screeners are externally analyzed by Nutrition Quest (https://www.nutritionquest.com/) with outcomes measured in number of servings consumed.
Change in Mother's Physical Activity From enrollment to 3 months, 9 months, and 15 months Change in mothers' minutes per day of accelerometer-assessed moderate-to-vigorous physical activity; worn for at least four 10+ hour days.
Trial Locations
- Locations (1)
San Diego State University
🇺🇸San Diego, California, United States
San Diego State University🇺🇸San Diego, California, United StatesElva ArredondoContact(619) 594-3481earredon@sdsu.edu