Clinical trial NCT00690326: Behavioral Change Communication (BCC) to Promote Physical Activity Among Females With Type 2 Diabetes Mellitus Attending Diabetic Clinic
Official title: Behavioral Change Communication to Promote Physical Activity Among Females With Type 2 Diabetes Mellitus Attending Diabetic Clinic.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: physical activity
Diabetes mellitus
Behavioral change communication
Household physical activity
Lead sponsor: Thiruvananthapuram Medical College
Sponsor class: OTHER
First posted: 2008-06-04
Enrollment: 86
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
measure: incremental physical activity
timeFrame: at the end of 4 months-October
Secondary outcomes:
measure: glycosylated hemoglobin
timeFrame: At the end of 4 months -October
Other outcomes:
Locations:
city: Thiruvananthapuram
country: India
facility: Diabetic clinic,Thiruvananthapuram medical college hospital
state: Kerala
Study officials:
affiliation: CERTC-Clinical epidemiology research&training centre,Trivandrum medical college
name: Rose D Chakola, MD MPhil
role: PRINCIPAL_INVESTIGATOR
References: