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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05540509
Other study ID # PHS 11-252
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 23, 2012
Est. completion date May 1, 2013

Study information

Verified date September 2022
Source California State University, Long Beach
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 1, 2013
Est. primary completion date May 1, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
California State University, Long Beach

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
Primary 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 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. Physical Activity Self-efficacy assessments were conducted at baseline and at one, two, and three months post-intervention.
Secondary 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. Fitness Self-efficacy assessments were conducted at baseline and at one, two, and three months post-intervention.
Secondary 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. Social support assessments were conducted at baseline and at one, two, and three months post-intervention.
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