The marked discrepancy between predicted and actual prevalence of Type2 diabetes Mellitus (DM) with the actual cases rising earlier than expected, underscore the continuing relevance of tailored awareness and management strategies including physical activity(PA) to combat growing diabetes pandemic. Research is needed to develop effective programs that promote PA among female patients.Design& Method randomized controlled trial . 86 females 30 -65 years with type 2 DM attended Diabetic Clinic out patient at government tertiary care hospital,Kerala, south India from May to October 2006 including one week pilot study, participant selection, random allocation and intervention. Block randomized to intervention(43) and control(43) groups. Intervention-'Behavioral change communication model, including 30 mints 'PA promotion video',pamphlet and last week recall and report of PA using an interview schedule for 4 consecutive visits. measures- Total PA/day calculated in calorie from METs(metabolic equivalent score) , HbA1C, Total knowledge score, stage of change of behavior, the baseline PA under four domains in Metabolic Equivalent Task Score by interview using IPAQ(International Physiclal Activity Questionnaire) long form, body weight, occupation and source of water.

Physical activity recommendations according to Centres for Disease Control and Prevention Atlanta guide lines-

• Moderate intensity PA-30 mins./day(4-6.5 MET) for 5 days/week (brisk walk).Subjective assessment of moderate exercise -

1. talk test-One who is on a moderate intensity level should be able to carry on a conversation comfortable while engagement in the activity.
2. Vigorous intensity PA >6.5METs-Person will not be able to carry out conversation. running, aerobics for 20 mins

Sample size calculation

n=Z square x (1-∝/2 ) x[ 2 S square ] / d square.

Z square (0.975)

(alpha)∝=5% 1-∝/2 =7.5 S(pooled standard deviation from pilot study) =18,

• Precision(d)=10(10% of mean)
• Desired confidence interval(CI)-95% n(no. in one arm)=39

n adjusted for 5% drop out = 39/(1-0.05*1-0.05)=

39/(1 - 0.05)2=39/(0.95*0.95)=43 in one arm

Sampling Method

• From Diabetic Clinic OP(out patient) for 4 consecutive fridays.
• Average 80 patients attend per one OP clinic, of which 40 are females .
• Recruited around 22 patients from one op following inclusion and exclusion criteria by two assistants using a Health screening questionnaire

Females with type2 Diabetes mellitus(T2DM) on oral hypoglycemics 30-65yrs excluding 2 patients from same family, those with nephropathy, history of myocardial infarction and those advised by doctor not to exert.

Timeline

• Ethical committee clearance 17/5/06
• Thesis protocol presented at Dept. of medicine and Diabetology 19/5/06
• Pilot study-(15 patients) 26/5/2006
• Patient screening &recruitment on 2/6,16/6,23/6,30/6.Informed about the program, collected address & telephone numbers.Intervention started from 7/7/2006.

Followed up for 4 visits ,once in a month, measured physical activity(PA) and reinforcement done with PA promotion video at each visit.

Pilot study:

The interview schedule questionnaires were administered by 2 interviewers in diabetic clinic for 15 random female patients. first interviewer asked the questions, the second interviewer also completed the same questionnaires in next visit. The completed questionnaires were compared using Kappa statistics for agreement regarding physical activity and knowledge score measurements. administration time was 25 to 30 minutes. Piloting helped to give training for the assistants in diabetic clinic in different elements of research process, to estimate the variability in measured Physical activity(PA) in metabolic equivalent task score (METs) to calculate sample size and to culturally adapt questions and to modify the questions.From the focussed group discussion the emergent theme was 'sedentary lifestyle among unemployed women'. Diabetic patient is helped by family members in routine life involving physical exertion.

Definitions

• Physical activity(PA)-Any bodily movement produced by skeletal muscles that result in expenditure of energy

Data collection Tools and collection procedure: IPAQ (international physical activity questionnaire)long form.

Data collection by 2 trained assistants the the assistants using the interview Schedule for PA promoting programme among females with T2DM The Section - I of the interview schedule collects Personal data, demographic data and Clinical Data relevant for this study. Section - II of the interview schedule collects Knowledge of DM & PA Under following domains Occupational, Domestic Transportation and Leisure time PA

Section - III The PA questionnaire-recall & report over a set period of time. It collects Moderate and heavy Physical activity frequency of the subject in minutes for past 1 week, converted into energy expenditure(kcal per min) using formula = 0.0175 kcal x METs x minutes (time of activity) x Body Weight (kg).From this calorie expenditure per day is calculated by dividing with actual number of days for which moderate or vigorous PA was done

METS of specific activities are given by 'compendium of Physical activities. Total PA score is calculated by adding 4 domains.

-recall &report over a set period of last one week. From total PA / week calories spent for one day calculated for comparison during analysis

Adverse event reporting -

Non systematic collection approach. enquired and collection approach. Reported or enquired if any, during preplanned visits.

1. Physical injuries/ pain related to increased PA (muscle strains, joint pain
2. Hypoglycemic episodes(dizziness)
3. chest pain, excessive fatigue, or shortness of breath.
4. Psychological effects - increased anxiety or stress related to the intervention.
5. Any other unexpected health deterioration or complications triggered by the behavioral change program.

Secondary objectives

1.Blood glucose change 2 Knowledge of diabetes & physical activity 3 change of stage of behaviour using questionnaire 4 To evaluate the programme after the study by the participants

1. measured by Glycosylated Haemoglobin(HbA1c)

2. Change in knowledge score-A set of 7 questions before and after the study.(Arbitrary scoring given by the investigator (Score 1for each correct answer) regarding diabetes, insulin resistance and PA.

3. Assessment of stage of behavioural change (SOC) using questionnaire

   • Precontemplation stage - not thinking about change( from sedentary to be physically active)
   • Contemplation- thinking about changing sedentary routine of life
   • Preparation- doing some physical activity
   • Action - doing enough physical activity
   • Maintenance - making physical activity a habit
   • Participants were invited by telephone and others by postal message.
   • Intervention- PA promotion video projection on 7/7,8/7,14/7/2016
   • Pamphlets for controll gp 15/7,21/7 blood collected for HbA1c.
   • 1st day projection arrangement done with the help of private arrangement, following 3 arrangements by Institute of Nova Kidney Foundation on recommendation from Dept. of Nephrology.
   • followed up till october.
   • visits were conveniently fixed on fridays- Diabetic clinic op During the last visit blood collected for HbA1c

Statistical analysis of Baseline measures and outcome measures done

Source of water- Understanding water sources helped in designing PA programs, as it is a substantial component of women's household PA.

Stage of Behaviour-

The HbA1c blood test- Knowledge score regarding T2DM, insulin resistance and PA. Scientific knowledge about role of physical activity in blood sugar regulation can change the attitude of behaviour regarding physical activity. This can motivate them from stage of pre & contemplation to action stage.

After intervention period-

Physical activity in METs converted to calorie expenditure.Added together and decided with number of days involved to get total calorie expenditure/day.

Comparison of "Total PA" after intervention period between the intervention and control group by ANCOVA 'adjusted for base line difference in PA'

Comparison of log transformed data of PA under different domains after intervention period between the intervention and control group.Geometric mean and variability were analysed

HbA1c by t test and mean change in knowledge score by Mann-Whitney Test after intervention.

Ordinal Regression analysis examining association of the grouping variable(intervention/control),knowledge score, and 'exposure to media' to dependent variable -the 'stages of change' -pre contemplation-stage1,contemplation-2,preparation-3,action-4, and maintenance-5

'Post test evaluation' after intervention period by all participants Q1-Did you enjoy the program? Q2-comments Q 3-Do you want to continue with the program ? Preferred day? Q4- What keeps you from not coming to a Physical Activity Promoting Programme regularly?

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

Females aged 30 to 65 years with Diabetes Mellitus type 2 attending diabetic clinic Out Patient clinic at Diabetic Clinic OP

It is patient data, submitted to the university as part of fulfilment of degree