Clinical trial NCT04736030: Conmigo: A Mother-daughter Intervention to Promote Physical Activity
Official title: A Mother-daughter Intervention to Promote Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Women
Hispanic Americans
Child
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 150
Sex: FEMALE
Minimum age (years): 8
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Delayed abbreviated intervention
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* the daughter is between the ages of 8-11 years old
* the daughter is not meeting Centers for Disease Control and Prevention's (CDC's) 2018 PA guidelines (60 min MVPA/day)
* the mother is the daughter's primary caregiver as defined by living with her 4 or more days out of the week
* both the mother AND daughter self-identify as Latina
* mother and daughter have an internet-capable device and reliable internet access to attend program activities
* mother AND daughter live in San Diego county and plan to remain in the area for the study period.

Exclusion criteria:

* mother OR daughter has a health condition precluding them from engaging in PA (assessed using the Physical Activity Readiness Questionnaire, PAR-Q, and PAR-Q Youth); women and girls reporting any risk factors will be required to submit proof of medical clearance to participate.
* mother OR daughter has a cognitive impairment preventing participation
* mother OR daughter has inability to complete the informed consent in English or Spanish.

Primary outcomes:
measure: Change in daughters' Moderate to Vigorous Physical Activity (objective) from baseline (M1) to post-intervention (M2 at 3 months).
timeFrame: 3 months
measure: Change in daughters' Moderate to Vigorous Physical Activity (self-report) from baseline (M1) to post-intervention (M2 at 3 months).
timeFrame: 3 months
measure: Sustainment of daughters' Moderate to Vigorous Physical Activity (self-report) at M3 (6 months)
timeFrame: 6 months
Secondary outcomes:
measure: Change in mothers' Moderate to Vigorous Physical Activity (objective) from baseline (M1) to post-intervention (M2 at 3 months).
timeFrame: 3 months
measure: Change in mothers' Moderate to Vigorous Physical Activity (self-report) from baseline (M1) to post-intervention (M2 at 3 months).
timeFrame: 3 months
measure: Sustainment of mothers' Moderate to Vigorous Physical Activity (self-report) at M3 (6 months)
timeFrame: 6 months
measure: Mother-daughter communication
timeFrame: baseline, 3 months, 6 months
measure: Mothers' parenting strategies for physical activity
timeFrame: baseline, 3 months, 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University Research Foundation
state: California
Study officials:
affiliation: San Diego State University
name: Elva M Arredondo, PhD
role: PRINCIPAL_INVESTIGATOR
References: