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

Thiruvananthapuram Medical College

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: Behavioral change communication to promote physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT00690326

Physical activity RCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No 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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

treatment type: behavioral(lifestyle counseling) treatment name: behavioral change communication to promote physical activity

Treatment:

Behavioral: Behavioral change communication to promote physical activity

Behavioral: Behavioral change communication to promote physical activity

B

Placebo Comparator group

Description:

Arm B given placebo comparator ie pamphlets

Treatment:

Behavioral: Behavioral change communication to promote physical activity

Behavioral: Behavioral change communication to promote physical activity