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

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02342535
• Collaborator: Metropolitan Asian Family Services (Other)
• Enrollment: 68
• Locations: 2
• Arm: 1
• Duration (Months): 12
• Patients Per Site: 34
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

The goal of this study is to pilot-test a culturally-salient physical activity intervention, using a randomized design, among under served, overweight/obese South Asian women at high risk for developing Diabetes.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus; Physical Activity	Behavioral: Physical Activity	N/A

Detailed Description

Regular physical activity prevents type 2 diabetes mellitus (DM). Although physical inactivity and DM are common in the United States (US), the investigators data, and others,have shown that Asian Indian and Pakistani (South Asian) women are at even greater risk. South Asians (SA) are one of the fastest growing segments of the US population.Studies show that SA women have a markedly higher DM prevalence and are less physically active than women from other racial/ethnic groups.SA also have greater insulin resistance and visceral adiposity at a lower body mass index (BMI). A combination of regular, moderate intensity physical activity (PA) and resistance exercises has been shown to decrease visceral adiposity and improve insulin sensitivity, even without weight loss; thus, PA may be especially important for DM prevention among SA women. Despite being at increased risk, very few evidence-based DM prevention and PA interventions exist for SA women in the US.

This proposal builds on a successful academic-community partnership between Northwestern University and Metropolitan Asian Family Services, an organization that provides health care and social services to lower-income SA immigrant families. The partnership has focused on translating and implementing evidence-based lifestyle interventions for SA immigrants in real-world, clinic and community settings. The investigators formative research found that SA women, in particular, were not being reached by current efforts to promote PA. Importantly, however, the main reasons for the reduced effectiveness of traditional strategies for PA promotion related more to socio-cultural perceptions and beliefs than simply to language barriers. SA women reported little PA and had difficulty even defining exercise. Although 75% of women were sedentary and overweight, they did not recognize these as risk factors for DM. Lack of knowledge about benefits of PA, cultural and linguistic isolation, concerns about modesty, and rigid gender roles strongly influenced SA women's proclivity for physical inactivity. In this context, much more work will be needed to address SA women's physical inactivity than simple language translation of proven lifestyle interventions.

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Community-Clinic Partnership to Promote Physical Activity in South Asian Women
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Behavioral: Physical Activity; Culturally tailored physical activity intervention for South Asian women and their children.

Outcome Measures

Primary Outcome Measures

1. Change in Physical Activity (Minutes/Week) [Baseline and 4 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Should meet all the 3 criteria below and meet the criteria for option 4 below or should meet the criteria for 5 as well as 6.

1. Self-identified as South Asian

2. Women

3. Have children between the ages of 6 and 14 years. AND Meet either of the criteria below

4. History of gestational diabetes during any of the pregnancies Or

5. Body Mass Index between 25 and 35 kg/m2 And

6. Family history of diabetes in a first degree relative.

Exclusion Criteria:

• Blood pressure of over 160/100 mm Hg

• History of diabetes

• Saying Yes to any question on the Exercise Assessment and Screening for You (EASY) exercise screening tool

• Currently pregnant or trying to get pregnant in the next year

• Planning to move out of Illinois in the next 6 months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University-Feinberg School of Medicine	Chicago	Illinois	United States	60611
2	Metropolitan Asian Family Services	Chicago	Illinois	United States	60645

Sponsors and Collaborators

• Northwestern University
• Metropolitan Asian Family Services

Investigators

• Principal Investigator: Namratha Kandula, MD,MPH, Assistant Professor, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Namratha Kandula, Assitant Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT02342535
• Other Study ID Numbers: STU00101433
• First Posted: Jan 21, 2015
• Last Update Posted: Jun 26, 2017
• Last Verified: Apr 1, 2017

Study Results

Participant Flow

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

Arm/Group Title	Physical Activity Intervention
Arm/Group Description	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.
Period Title: Overall Study
STARTED	68
COMPLETED	68
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Physical Activity Intervention
Arm/Group Description	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.
Overall Participants	68
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40 (5)
Sex/Gender, Customized (participants) [Number]
Female Parent	30 44.1%
Female Child	17 25%
Male Child	21 30.9%
Race/Ethnicity, Customized (participants) [Number]
South Asian	68 100%
Region of Enrollment (participants) [Number]
United States	68 100%

Outcome Measures

1. Primary Outcome

Title	Change in Physical Activity (Minutes/Week)
Description	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.
Time Frame	Baseline and 4 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Physical Activity Intervention
Arm/Group Description	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.
Measure Participants	30
Baseline	42 (104)
Post intervention at 4 months	58 (117)

Adverse Events

Arm/Group Title	Physical Activity Intervention
Arm/Group Description	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.
All Cause Mortality
	Physical Activity Intervention
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Physical Activity Intervention
	Affected / at Risk (%)	# Events
Total	0/68 (0%)
Other (Not Including Serious) Adverse Events
	Physical Activity Intervention
	Affected / at Risk (%)	# Events
Total	0/68 (0%)

Limitations/Caveats

Limitations of this pilot study are inclusion of a single site in Chicago, lack of a control arm, and that we were only able to recruit and enroll 20% of the individuals we approached.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.