Active Moms Project: Physical Activity Intervention for Low-Income Mothers

September 12, 2022 updated by: Guido Urizar, California State University, Long Beach

Active Moms: A Feasibility Study of a Community-Based and Home-Based Physical Activity Intervention for Low-Income, Ethnic-Minority Mothers

Despite the health benefits of physical activity, increasing regular physical activity levels among low-income, ethnic-minority mothers has remained a significant challenge. The current mixed-methods feasibility study explored the impact that a three-month community-based (CBI) and a home-based intervention (HBI) had on improving physical activity and fitness levels, as well as psychosocial outcomes (self-efficacy and social support) among low-income, ethnic-minority mothers. These results support the efficacy of CBIs and HBIs in improving PA and fitness levels and have important implications for improving health outcomes among low-income, ethnic-minority mothers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Despite the health benefits of physical activity, increasing regular physical activity levels among low-income, ethnic-minority mothers has remained a significant challenge. Yet, few studies have examined the feasibility of implementing interventions to address physical activity barriers often experienced by this population. The current mixed-methods feasibility study explored the impact that a three-month community-based (CBI) and a home-based intervention (HBI) had on improving physical activity and fitness levels, as well as psychosocial outcomes (self-efficacy and social support) among low-income, ethnic-minority mothers. Thirty mothers were randomized to either a three-month community-based intervention (CBI) or a home-based intervention (HBI) and completed pre- and post-intervention assessments of physical activity (self-report, accelerometer), fitness (cardiorespiratory, muscle endurance and strength, flexibility), self-efficacy, and social support. Post-intervention focus groups were also conducted. Through formative research, this pilot work will develop and empirically test a CBI and HBI among low-income mothers for use in local community centers. The results of the proposed work have substantial public health implications and are expected to advance the investigator's understanding of how low-income mothers effectively use these intervention modalities to adopt healthy behaviors and produce change that can positively impact their health, as well as that of their children. Further, the proposed research will yield two physical activity interventions that can be readily delivered in community settings, are scalable, and are relatively low cost. Finally, these results will help identify those subgroups of mothers that may do particularly well (or poorly) with these innovative approaches to physical activity adoption and maintenance. This has important implications for the tailoring of physical activity programs to individual needs and preferences.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18 years of age or older
  • a mother of a young child (<10 years of age)
  • fluent in either Spanish or English
  • Sedentary (i.e., not engaging in 90 minutes or more of moderate or vigorous physical activity per week)

Exclusion Criteria:

  • Not medically cleared by a doctor or by a medical history screener to engage in moderate-intensity physical activity
  • Currently pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Community-based intervention
This program consisted of 12 group exercise sessions over a three-month period that were offered in Spanish and English. Each two-hour session consisted of 90 minutes of flexibility, cardiovascular, and strength exercises to meet physical activity recommendations and 30 minutes of group discussions that focused on topics related to the adoption and maintenance of physical activity.
Behavioral: Community-based intervention
Mothers were given physical activity goals and coping resources to practice at home and were asked to record their experiences on an activity log. Course content was taught from a detailed training manual and was based on concepts and strategies from social cognitive theory that have been effective in increasing physical activity and fitness levels among mothers. In the first month, mothers attended group exercise sessions twice per week (total of eight group sessions) and exercised on their own once per week. In the second month, mothers attended group exercise sessions once per week (total of four group sessions) and exercised on their own twice per week. In the third month, mothers exercised on their own three times per week.
Other Names:
  • CBI
Active Comparator: Home-based intervention
Mothers randomized to the HBI group participated in a three-month program where they were given print-based materials (offered in Spanish or English) at each monthly assessment time point. The print-based materials provided information on multiple cardiovascular, strength training, and flexibility exercises that they could do at home.
Behavioral: Home-based intervention
The HBI group received information on building social support and reducing physical activity barriers based on materials from the Diabetes Prevention Program. Participants were also given activity logs to record their physical activity each week, which was collected by research staff at each monthly assessment time point to assess how participants were progressing with their physical activity goals. Mothers exercised on their own for three months with the goal of meeting national physical activity guidelines
Other Names:
  • HBI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Physical Activity from baseline to 3 months post-intervention
Time Frame: Self-reported and fitbit physical activity assessments were conducted at baseline and at one, two, and three months post-intervention.
Self-reported duration of moderate/vigorous physical activity was assessed using the Check and Line Questionnaire (CALQ), with higher numbers representing greater average minutes of moderate/vigorous-intensity PA completed/day over a three-day assessment period. Objective physical activity was assessed using the Fitbit One (2009 version), which is an accelerometer worn on the hip (clipped to a participant's clothing at the waist). For the current study, very active minutes were examined (measure of basal metabolic rate/minute). Activity data was averaged across the three days that the Fitbit was worn, with greater number of very active minutes indicating greater daily moderate/vigorous-intensity physical activity levels.
Self-reported and fitbit physical activity assessments were conducted at baseline and at one, two, and three months post-intervention.
Change in Cardiorespiratory Fitness from baseline to 3 months post-intervention
Time Frame: Cardiorespiratory fitness assessments were conducted at baseline and at one, two, and three months post-intervention.
Cardiorespiratory fitness was assessed via predicted relative maximum oxygen consumption, also known as relative VO2 max (ml/kg/min) after participants completed a timed mile walk, with a greater relative VO2 max being an indicator of greater cardiorespiratory fitness.
Cardiorespiratory fitness assessments were conducted at baseline and at one, two, and three months post-intervention.
Change in Muscle Endurance from baseline to 3 months post-intervention
Time Frame: Muscle endurance assessments were conducted at baseline and at one, two, and three months post-intervention.
Muscle endurance was assessed by the number of modified push-ups completed in correct form, with a greater number of 90° push-ups completed representing greater muscular endurance.
Muscle endurance assessments were conducted at baseline and at one, two, and three months post-intervention.
Change in Flexibility from baseline to 3 months post-intervention
Time Frame: Flexibility assessments were conducted at baseline and at one, two, and three months post-intervention.
Flexibility was assessed by a modified sit and reach test (in inches) where mothers were instructed to reach forward as far as they could with their hands over each other, over a three-foot ruler, without removing their body from the wall and holding this position for at least two seconds, with greater inches indicating greater flexibility.
Flexibility assessments were conducted at baseline and at one, two, and three months post-intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Physical Activity Self-Efficacy from baseline to 3 months post-intervention
Time Frame: Physical Activity Self-efficacy assessments were conducted at baseline and at one, two, and three months post-intervention.
Physical Activity Self-efficacy was assessed using the Barriers Self-Efficacy Scale. The 14-item Barriers Self-Efficacy Scale measures a mother's level of confidence in engaging in physical activity despite barriers experienced over the next three months, with higher scores (range=0-100) reflecting higher self-efficacy for physical activity in the face of barriers.
Physical Activity Self-efficacy assessments were conducted at baseline and at one, two, and three months post-intervention.
Change in Fitness Self-Efficacy from baseline to 3 months post-intervention
Time Frame: Fitness Self-efficacy assessments were conducted at baseline and at one, two, and three months post-intervention.
Fitness Self-efficacy was assessed using the Self-Efficacy for Physical Performance Scale. The 5-item Self-Efficacy for Physical Performance Scale measures a participant's self-efficacy to currently perform multiple activities that improve fitness (e.g., walking a mile, doing push-ups), with higher scores (range=0-100) indicating higher self-efficacy for fitness.
Fitness Self-efficacy assessments were conducted at baseline and at one, two, and three months post-intervention.
Change in Social Support from baseline to 3 months post-intervention
Time Frame: Social support assessments were conducted at baseline and at one, two, and three months post-intervention.
Social support for physical activity was assessed using the 15-item Social Support for Exercise Survey. The Social Support for Exercise Survey measures the degree of social support received from one's family and friends to engage in physical activity, with higher scores (range=0-75) reflecting more social support received from each of these support networks.
Social support assessments were conducted at baseline and at one, two, and three months post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
California State University, Long Beach

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guido Urizar, PhD, California State University, Long Beach

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PHS 11-252

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Due to the sensitive nature of the questions asked in this study, survey respondents were assured raw data would remain confidential and would not be shared.

Data not available / The data that has been used is confidential

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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