Physical InactivityNCT05540509
Active Moms Project: Physical Activity Intervention for Low-Income Mothers
A study testing Community-based intervention and Home-based intervention in people with Physical Inactivity, run by California State University, Long Beach.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Community-based intervention and Home-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 23 May 2012to 1 May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Not medically cleared by a doctor or by a medical history screener to engage in moderate-intensity physical activity
- Currently pregnant
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Inactivity
- Being tested
- Community-based intervention, Home-based intervention
- Keywords
- physical activity, community, home, intervention, ethnic minority, mothers
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based interventionBehavioural
Also called CBI
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.
Home-based interventionBehavioural
Also called HBI
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
| Study group | Role | What they receive |
|---|---|---|
| Community-based intervention | Experimental | 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. Receives: Behavioral: Community-based intervention |
| Home-based intervention | Active comparator | 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. Receives: Behavioral: Home-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Activity from baseline to 3 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Flexibility assessments were conducted at baseline and at one, two, and three months post-intervention.
Secondary outcomes (3)
Change in Physical Activity Self-Efficacy from baseline to 3 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.
Measured: 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
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.
Measured: 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
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.
Measured: Social support assessments were conducted at baseline and at one, two, and three months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start23 May 2012
- Primary completion1 May 2013
- Study completion1 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- prospective, convergent mixed-methods, randomized group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- California State University, Long Beach
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Urizar, California State University, Long Beach
- Investigators
- Guido Urizar, PhD, Principal investigator, California State University, Long Beach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540509
- Sponsor's protocol ID
- PHS 11-252
- Status last verified
- Sep 2022
- First submitted
- 28 Jun 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Moms: A Feasibility Study of a Community-Based and Home-Based Physical Activity Intervention for Low-Income, Ethnic-Minority Mothers
- ClinicalTrials.gov ID
- NCT05540509
- Acronym / sponsor ID
- PHS 11-252
- Conditions
- Physical Inactivity
- Keywords
- physical activity, community, home, intervention, ethnic minority, mothers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- California State University, Long BeachUniversity, hospital or other
- Study start
- 23 May 2012 (actual)
- Primary completion
- 1 May 2013 (actual)
- Study completion
- 1 May 2013 (actual)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, convergent mixed-methods, randomized group design
| Arm | Type | Receives |
|---|---|---|
| Community-based intervention | Experimental | Behavioral: Community-based interventionThis 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. |
| Home-based intervention | Active comparator | Behavioral: Home-based interventionMothers 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Not medically cleared by a doctor or by a medical history screener to engage in moderate-intensity physical activity
- Currently pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community-based interventionAlso: CBIMothers 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. | Behavioural | Community-based intervention |
| Home-based interventionAlso: HBIThe 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 | Behavioural | Home-based intervention |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Urizar, PhD principal investigator
California State University, Long Beach
Questions about this trial
What is this clinical trial studying?
A study testing Community-based intervention and Home-based intervention in people with Physical Inactivity, run by California State University, Long Beach.
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 4 inclusion and 2 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 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 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.). The study lists 4 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 14 Sep 2022.