Behavioral Change Communication (BCC) to Promote Physical Activity Among Females With Type 2 Diabetes Mellitus Attending Diabetic Clinic (BCC)

June 3, 2008 updated by: Thiruvananthapuram Medical College

Behavioral Change Communication to Promote Physical Activity Among Females With Type 2 Diabetes Mellitus Attending Diabetic Clinic.

Type 2DM is present in the populations of almost all the countries in the world and is a significant disease burden in most countries .Evidences suggest that population in India develop Type 2 DM at an increasing rate as they reject their traditional life styles.

Awareness and knowledge regarding Diabetes and role of physical inactivity in producing complications is still grossly inadequate( Mohan. D, Raj.D Awareness and knowledge of Diabetes in Chennai.The Chennai urban Rural Epidemiology study(CURES-9)J Assoc. Physicians India 2005 April;53:283-7).Exercise is a low cost , non pharmacological intervention that has been shown to be effective in metabolic control. Exercise is still vastly under-utilized in the management of Type 2 DM.

Most proximal behavioral cause of insulin resistance is physical inactivity.(Michael J. LaMonte, Steven N. Blair et al.( Physical activity and Diabetes prevention J Appl Physiol. 99: 1205-1213,2005)

This study was designed to promote physical activity among type 2 DM female subjects aged 35-65 yrs attending Diabetic clinic of a tertiary care hospital in Kerala.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The BCC model consisted of 1.an audio visual module imparting knowledge about DM, its complications, advantages of PA in Diabetes control, how to include more PA in routine life style 2. pamphlets.All these were standardised. Physical activity was measured using international physical activity questionnaire validated(responsiveness& reliability) for our cultural activity.IPAQ covers four domains of physical activity: work-related,transportation, housework/gardening and leisure-time activity. PA data from the questionnaire were transformed into energy expenditure estimates as MET using published values. To calculate the weekly physical activity (MET-h /week), the number of hours dedicated to each activity class was multiplied by the specific MET score for that activity.

follow up once in a month (4 times) measure incremental physical activity and reinforcement in each visit. Students t test was used to compare the experimental and control groups with respect to the incremental physical activity measured in calorie expenditure. It was found that the incremental physical activity(final-basal) measured in METS is significantly higher in intervention group.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Kerala
      • Thiruvananthapuram, Kerala, India, 695011
        • Diabetic clinic,Thiruvananthapuram medical college hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • females 30to 65yrs. with type-2 Diabetes Mellitus.
  • Attending Diabetic clinic at a tertiary level hospital(medical college Thiruvananthapuram)
  • on oral hypoglycemics

Exclusion Criteria:

  • only one patient from one family
  • H/o myocardial infarction
  • nephropathy
  • autonomic neuropathy
  • severe limiting osteo arthritis
  • pregnancy
  • Mental incompetence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A

treatment type: behavioral(lifestyle counseling)

treatment name: behavioral change communication to promote physical activity
Behavioral: Behavioral change communication to promote physical activity

treatment type: behavioral (lifestyle counseling)

treatment name: behavioral change communication to promote physical activity

Behavioral: Behavioral change communication to promote physical activity

Arm B given placebo comparator ie pamphlet

Audiovisual module Physical activity frequency questionnaire
Placebo Comparator: B
Arm B given placebo comparator ie pamphlets
Behavioral: Behavioral change communication to promote physical activity

treatment type: behavioral (lifestyle counseling)

treatment name: behavioral change communication to promote physical activity

Behavioral: Behavioral change communication to promote physical activity

Arm B given placebo comparator ie pamphlet

Audiovisual module Physical activity frequency questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incremental physical activity
Time Frame: at the end of 4 months-October
at the end of 4 months-October

Secondary Outcome Measures

Outcome Measure
Time Frame
glycosylated hemoglobin
Time Frame: At the end of 4 months -October
At the end of 4 months -October

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thiruvananthapuram Medical College

Investigators

  • Principal Investigator: Rose D Chakola, MD MPhil, CERTC-Clinical epidemiology research&training centre,Trivandrum medical college

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

June 2, 2008

First Submitted That Met QC Criteria

June 3, 2008

First Posted (Estimate)

June 4, 2008

Study Record Updates

Last Update Posted (Estimate)

June 4, 2008

Last Update Submitted That Met QC Criteria

June 3, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Physical activity RCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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