Trial Outcomes & Findings for Community-Clinic Partnership to Promote Physical Activity in South Asian Women (NCT NCT02342535)

Results Overview

To test for differences in physical activity, we used mixed-effects models for pre- and post-intervention accelerometer data. In these models, the outcome was daily minutes of bout corrected moderate-vigourous physical activity. Time (pre/post-intervention) was treated as a binary variable in order to measure changes in physical activity. Models controlled for accelerometer wear time and weekend day.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

68 participants

Primary outcome timeframe

Baseline and 4 months

Results posted on

2023-04-06

Participant Flow

The total number of participants who signed up for the study were 68 and not 71.

Participant milestones

Participant milestones
Measure	Physical Activity Intervention Participants will attend bi weekly exercise classes for a total of 16 weeks, led by certified, and trained instructors. The participant's children between the ages of 6 and 14 years will participate in the martial arts class with the mothers. Physical Activity: Culturally tailored physical activity intervention for South Asian women and their children.
Overall Study STARTED	68
Overall Study COMPLETED	68
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Community-Clinic Partnership to Promote Physical Activity in South Asian Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Physical Activity Intervention n=68 Participants Participants will attend bi weekly exercise classes for a total of 16 weeks, led by certified, and trained instructors. The participant's children between the ages of 6 and 14 years will participate in the martial arts and yoga class with their mothers. Physical Activity: Culturally tailored physical activity intervention for South Asian women and their children.
Age, Continuous	40 years STANDARD_DEVIATION 5 • n=5 Participants
Sex/Gender, Customized Female Parent	30 participants n=5 Participants
Sex/Gender, Customized Female Child	17 participants n=5 Participants
Sex/Gender, Customized Male Child	21 participants n=5 Participants
Race/Ethnicity, Customized South Asian	68 participants n=5 Participants
Region of Enrollment United States	68 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 4 months

Population: We did not collect any data from the children, so all the data analysis is from the data obtained from the 30 mothers. To test for differences in physical activity, we used mixed-effects models for pre- and post-intervention accelerometer data. In these models, the outcome was daily minutes of bout corrected moderate-vigourous physical activity.

To test for differences in physical activity, we used mixed-effects models for pre- and post-intervention accelerometer data. In these models, the outcome was daily minutes of bout corrected moderate-vigourous physical activity. Time (pre/post-intervention) was treated as a binary variable in order to measure changes in physical activity. Models controlled for accelerometer wear time and weekend day.

Outcome measures

Outcome measures
Measure	Physical Activity Intervention n=30 Participants Participants will attend bi weekly exercise classes for a total of 16 weeks, led by certified, and trained instructors. The participant's children between the ages of 6 and 14 years will participate in the kids exercise class with their mothers. Physical Activity: Culturally tailored physical activity intervention for South Asian women and their children.
Change in Physical Activity (Minutes/Week) Baseline	42 minute/week activity Standard Deviation 104
Change in Physical Activity (Minutes/Week) Post intervention at 4 months	58 minute/week activity Standard Deviation 117

Adverse Events

Physical Activity Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Namratha Kandula

Northwestern University

Phone: 312-503-6470

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place