A Multi-level Mother-daughter Physical Activity Intervention for Pre- Adolescent Latinas
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age8-65
SponsorSan Diego State University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Self-identifying as Latina
aged 8-11
not currently meeting CDC's 2018 PA guidelines (60 min MVPA/day)
attends an elementary school enrolled in the study
Disqualifiers
either Mother or Daughter has a health condition that precludes them from doing PA
cognitive impairment affecting participation,
inability for mother to provide informed consent or daughter to provide assent in English or Spanish
Trial design
Design model
Parallel
Treatments tested in this trial
Physical Activity Promotion
BehavioralThe Conmigo Physical Activity intervention involves the delivery of ten weekly sessions led by YMCA Facilitators supported by Drs. Arredondo and Ayala, Project Manager and student research assistants. Mothers and daughters (8-11 years old) will be invited to participate in ten in-person 2-hour sessions on topics such as PA parenting, communication, goal setting, etc. Mothers and daughters participate together in most activities, with small group breakouts where just mothers or just daughters have separate activities during some sessions. Each session includes didactic teaching, skill building (e.g. role plays), interactive discussions, 30 minutes of group PA, and goal-setting/review of previous goals. Overall, the activities are designed to promote increased physical activity and mediators to PA (family communication, parenting strategies, etc.). Each cohort will include 12-15 mother-daughter dyads.
Healthy Eating
BehavioralThe Healthy Eating intervention involves the delivery of 10 sessions by YMCA facilitators supported by Drs. Arredondo and Ayala, the Project Manager, and student research assistants. Mothers and daughters (8-11 years old) will be invited to participate in 10 2-hour in-person sessions that include both large and small group activities. Overall, the activities are designed to promote engagement in dietary behavioral strategies and parenting strategies across contexts and settings to promote fruit, vegetable and fiber consumption. Large and small groups activities include goal setting, implementation planning, homework activities, and focused discussion on mediators (e.g., family communication, parenting strategies) and moderators (e.g. acculturation). Each cohort will include 12-15 mother-daughter dyads.
Treatment groups
432 Participants
are divided into 2 treatment groupsGroup A: Physical Activity InterventionExperimental treatment 1 intervention
Group B: Healthy Eating Intervention (attention control program)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in daughters' objective PA
Change in daughters' accelerometer-assessed minutes per day of moderate-to-vigorous physical activity (MVPA); worn for at least four 10+ hour days.
Time frame
From enrollment to 3 months, 9 months, and 15 monthsSecondary outcomes
1
Change in Mother-daughter communication
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.
Time frame
From enrollment to 3 months, 9 months, and 15 months2
Change in Physical Activity Parenting Strategies
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.
Time frame
From enrollment to 3 months, 9 months, and 15 months3
Change in Daughters' Dietary Intake
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.
Time frame
From enrollment to 3 months4
Change in Mother's Physical Activity
Change in mothers' minutes per day of accelerometer-assessed moderate-to-vigorous physical activity; worn for at least four 10+ hour days.
Time frame
From enrollment to 3 months, 9 months, and 15 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
San Diego State University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov