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

This study has been completed.
Sponsor:
Information provided by:
Thiruvananthapuram Medical College
ClinicalTrials.gov Identifier:
NCT00690326
First received: June 2, 2008
Last updated: June 3, 2008
Last verified: June 2008
History of Changes
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
 Behavioral: Behavioral change communication to promote physical activity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Behavioral Change Communication to Promote Physical Activity Among Females With Type 2 Diabetes Mellitus Attending Diabetic Clinic.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Thiruvananthapuram Medical College:

Primary Outcome Measures:
  • incremental physical activity [ Time Frame: at the end of 4 months-October ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • glycosylated hemoglobin [ Time Frame: At the end of 4 months -October ] [ Designated as safety issue: Yes ]

Enrollment: 86
Study Start Date: May 2006
Study Completion Date: October 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: B
Arm B given placebo comparator ie pamphlets
 Behavioral: Behavioral change communication to promote physical activity

Arm B given placebo comparator ie pamphlet

Audiovisual module Physical activity frequency questionnaire

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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690326

Locations
India
Diabetic clinic,Thiruvananthapuram medical college hospital
Thiruvananthapuram, Kerala, India, 695011
Sponsors and Collaborators
Thiruvananthapuram Medical College
Investigators
Principal Investigator: Rose D Chakola, MD MPhil CERTC-Clinical epidemiology research&training centre,Trivandrum medical college
  More Information

No publications provided

Responsible Party: Dr. Rose Dvy.C, Assistant professor Dept. Physiology,Thiruvananthapuram Medical College
ClinicalTrials.gov Identifier: NCT00690326     History of Changes
Other Study ID Numbers: Physical activity RCT
Study First Received: June 2, 2008
Last Updated: June 3, 2008
Health Authority: India: Institutional Review Board

Keywords provided by Thiruvananthapuram Medical College:
physical activity
Diabetes mellitus
Behavioral change communication
Household physical activity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013