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

Sponsor

Thiruvananthapuram Medical College (Other)

Overall Status

Completed

CT.gov ID

NCT00690326

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

17.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Behavioral: Behavioral change communication to promote physical activity Behavioral: Behavioral change communication to promote physical activity	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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.

Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Jul 1, 2006

Actual Study Completion Date :

Oct 1, 2006

Arms and Interventions

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
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

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

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

Outcome Measures

Primary Outcome Measures

incremental physical activity [at the end of 4 months-October]

Secondary Outcome Measures

glycosylated hemoglobin [At the end of 4 months -October]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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