NCT05540509

Brief 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 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
9.2 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

11 months

First QC Date

June 28, 2022

Last Update Submit

September 12, 2022

Conditions

Keywords

physical activitycommunityhomeinterventionethnic minoritymothers

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    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 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 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 assessments were conducted at baseline and at one, two, and three months post-intervention.

Study Arms (2)

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.

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.

Behavioral: Home-based intervention

Interventions

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.

Also known as: CBI
Community-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

Also known as: HBI
Home-based intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Guido Urizar, PhD

    California State University, Long Beach

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Staff completing assessments were blind to participants' study condition
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: prospective, convergent mixed-methods, randomized group design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 28, 2022

First Posted

September 14, 2022

Study Start

May 23, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

September 14, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

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