Conmigo: A Mother-daughter Intervention to Promote Physical Activity

NCT04736030 | Completed DMC

• 1 other identifier: R21HD100776
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise; Women; Hispanic Americans; Child

Outcome Measures

Primary Outcomes (3)

• 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.

  3 months

• 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.

  3 months

• Sustainment of daughters' Moderate to Vigorous Physical Activity (self-report) at M3 (6 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 6 months to PA at baseline and 3 months to assess sustainment of MVPA three months after the intervention has ended.

  6 months

Secondary Outcomes (5)

• Change in mothers' Moderate to Vigorous Physical Activity (objective) from baseline (M1) to post-intervention (M2 at 3 months).

  3 months

• Change in mothers' Moderate to Vigorous Physical Activity (self-report) from baseline (M1) to post-intervention (M2 at 3 months).

  3 months

• Sustainment of mothers' Moderate to Vigorous Physical Activity (self-report) at M3 (6 months)

  6 months

• Mother-daughter communication

  baseline, 3 months, 6 months

• Mothers' parenting strategies for physical activity

  baseline, 3 months, 6 months

Study Arms (2)

Conmigo PA Intervention

EXPERIMENTAL

12-week program (90 minutes/week)

Behavioral: Intervention

Delayed Abbreviated Intervention

NO INTERVENTION

No intervention during experimental phase; participants in control group receive abridged program after the final measurement point (wait list control).

Interventions

Intervention BEHAVIORAL

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).

Also known as: Conmigo

Conmigo PA Intervention

Eligibility Criteria

• Age: 8 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Diego State University: lead

Study Sites (1)

San Diego State University Research Foundation

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Elva M Arredondo, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Delayed abbreviated intervention

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 3, 2021
• Study Start: February 11, 2021
• Primary Completion: January 24, 2023
• Study Completion: April 19, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available after initial data analyses and preparation of major publications.
• Access Criteria: Researchers interested in accessing the data must complete a registration process and must agree to the conditions of use, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource. Those interested in accessing data must submit a brief proposal describing the intended use of the data; the investigative team will determine the scientific soundness of the proposal, as well as whether adequate data protections in place, as part of the decision for the researcher to be able to access the dataset.

Locations

US (1)