NCT02342535

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

2 active sites

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

September 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

June 26, 2017

Completed
Last Updated

April 6, 2023

Status Verified

April 1, 2023

Enrollment Period

11 months

First QC Date

January 15, 2015

Results QC Date

May 13, 2016

Last Update Submit

April 4, 2023

Conditions

Diabetes MellitusPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Physical activity intervention

OTHER

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

Interventions

Physical ActivityBEHAVIORAL

Culturally tailored physical activity intervention for South Asian women and their children.

Physical activity intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Self-identified as South Asian
  • Women
  • Have children between the ages of 6 and 14 years. AND Meet either of the criteria below
  • History of gestational diabetes during any of the pregnancies Or
  • Body Mass Index between 25 and 35 kg/m2 And
  • Family history of diabetes in a first degree relative.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwestern University-Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Metropolitan Asian Family Services

Chicago, Illinois, 60645, United States

Location

MeSH Terms

Conditions

Diabetes MellitusMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Limitations and 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.

Results Point of Contact

Title
Dr. Namratha Kandula
Organization
Northwestern University
nkandula@nm.org
312-503-6470

Study Officials

  • Namratha Kandula, MD,MPH

    Assistant Professor, Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assitant Professor

Study Record Dates

First Submitted

January 15, 2015

First Posted

January 21, 2015

Study Start

September 1, 2014

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

April 6, 2023

Results First Posted

June 26, 2017

Record last verified: 2023-04

Locations

US(2)