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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342535
• Other study ID #: STU00101433
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: April 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Physical Activity

Intervention

Behavioral:
• Physical Activity
Culturally tailored physical activity intervention for South Asian women and their children.

Locations

Country	Name	City	State
United States	Metropolitan Asian Family Services	Chicago	Illinois
United States	Northwestern University-Feinberg School of Medicine	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Metropolitan Asian Family Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Physical Activity (Minutes/Week)	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.	Baseline and 4 months