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ExerciseConmigoNCT04736030

Conmigo: A Mother-daughter Intervention to Promote Physical Activity

A study testing Intervention in people with Exercise and Women, run by San Diego State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Exercise, Women, Hispanic Americans
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
1 siteUnited States
Study dates
11 Feb 2021to 19 Apr 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • San Diego State University Research Foundation

    San Diego, California, 92123

Other trials in United States

About this study

Official title: A Mother-daughter Intervention to Promote Physical Activity

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.

Read the 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.

Being tested
Intervention
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterventionBehavioural

    Also called Conmigo

    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).

Study groups in NCT04736030
Study groupRoleWhat they receive
Conmigo PA InterventionExperimental12-week program (90 minutes/week)
Receives: Behavioral: Intervention
Delayed Abbreviated InterventionNo interventionNo intervention during experimental phase; participants in control group receive abridged program after the final measurement point (wait list control).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Daughters' Moderate to Vigorous Physical Activity (Objective) From Baseline (M1) to Post-intervention (M2 at 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.

    Measured: 3 months

  2. Change in Daughters' Moderate to Vigorous Physical Activity (Self-report) From Baseline (M1) to Post-intervention (M2 at 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).

    Measured: 3 months

  3. Sustainment of Daughters' Moderate to Vigorous Physical Activity (Self-report) at M3 (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).

    Measured: 6 months

Secondary outcomes (5)
  1. Change in Mothers' Moderate to Vigorous Physical Activity (Objective) From Baseline (M1) to Post-intervention (M2 at 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.

    Measured: 3 months

  2. Change in Mothers' Moderate to Vigorous Physical Activity (Self-report) From Baseline (M1) to Post-intervention (M2 at 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.

    Measured: 3 months

  3. Sustainment of Mothers' Moderate to Vigorous Physical Activity (Self-report) at M3 (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.

    Measured: 6 months

  4. Mother-daughter Communication

    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.

    Measured: baseline, 3 months, 6 months

  5. Mothers' Parenting Strategies for Physical Activity

    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.)

    Measured: baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2021
  2. Study start11 Feb 2021
  3. Primary completion24 Jan 2023
  4. Study completion19 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Delayed abbreviated intervention
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04736030
Sponsor's protocol ID
HS-2019-0197
Other IDs
R21HD100776
Acronym
Conmigo
Status last verified
May 2026
First submitted
25 Jan 2021
Last updated
23 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The final dataset will be an electronic database containing objective (accelerometer) and self-report (survey with primary and secondary outcomes, demographic information, etc.) variables from baseline, 3 months and 6 months. Data will be de-identified to remove all subject identifiers.

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Exercise and Women, run by San Diego State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Daughters' Moderate to Vigorous Physical Activity (Objective) From Baseline (M1) to Post-intervention (M2 at 3 Months). (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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