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

Type 2 Diabetes Mellitus Clinical Trial

— BCC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690326
• Other study ID #: Physical activity RCT
• Status: Completed
• Phase: N/A
• First received: June 2, 2008
• Last updated: June 3, 2008
• Start date: May 2006
• Est. completion date: October 2006

Study information

• Verified date: June 2008
• Source: Thiruvananthapuram Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Mental Disorders
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Behavioral change communication to promote physical activity
treatment type: behavioral (lifestyle counseling) treatment name: behavioral change communication to promote physical activity
• Behavioral change communication to promote physical activity
Arm B given placebo comparator ie pamphlet Audiovisual module Physical activity frequency questionnaire

Locations

Country	Name	City	State
India	Diabetic clinic,Thiruvananthapuram medical college hospital	Thiruvananthapuram	Kerala

Sponsors (1)

Lead Sponsor	Collaborator
Thiruvananthapuram Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incremental physical activity		at the end of 4 months-October	Yes
Secondary	glycosylated hemoglobin		At the end of 4 months -October	Yes