The Effectiveness of 'A BCC Model' in Promoting Physical Activity Among Females With Type 2 Diabetes Mellitus:A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- incremental physical activity
研究概览
简要总结
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 -
- talk test-One who is on a moderate intensity level should be able to carry on a conversation comfortable while engagement in the activity.
- Vigorous intensity PA >6.5METs-Person will not be able to carry out conversation. running, aerobics for 20 mins
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •females 30to 65yrs. with type-2 Diabetes Mellitus.
- •Attending Diabetic clinic at a tertiary level hospital(medical college Thiruvananthapuram)
- •on oral hypoglycemics
排除标准
- •only one patient from one family
- •H/o myocardial infarction
- •nephropathy
- •autonomic neuropathy
- •severe limiting osteo arthritis
- •pregnancy
- •Mental incompetence
研究组 & 干预措施
Intervention group
intervention for experimental arm : 'Behavioral change communication model' including a physical activity promotion video(30 explains showing how to be physical active in daily routines of life to control blood sugar) , pamphlet-'Physical Activity(PA) to control Diabetes Mellitus' and last week recall and report of PA using IPAQ-international questionnaire long form. Followed up for 4 months by 4 consecutive visits when video show repeated .
Video content- PA is scientifically proved to be effective in controlling diabetes mellitus and preventing long term complications of diabetes mellitus. 30 mints. continuous / 10 mints. intermittent brisk walks with a short gap in between - for 5 days is recommended.
Incorporate into daily life as occupational, household, transportation and leisure time PA. Carry water from well, scrub the floor with hands while on knee and hands, walk by getting down in the previous bus stop, use staircase, walk briskly swinging both hands.
干预措施: Behavioral change communication model(BCC) to promote physical activity (Behavioral)
control group
Participants of control group were distributed with placebo, the " printed pamphlets " physical activity to control Diabetes Mellitus.Followed up for 4 months by 4 consecutive visits in diabetic clinic OP. Measured each time their physical activity by last week recall and report of PA using IPAQ-international physical activity questionnaire and to report any adverse events related physical activity.
干预措施: pamphlet-The printed pamphlet,'Physical activity:To control blood sugar/ Diabetes Mellitus' (Other)
结局指标
主要结局
incremental physical activity
时间窗: at the end of 4 months-October
Total Physical Activity Log Means and Geometric Means With Standard Deviation in Intervention and Control Groups After Intervention.
时间窗: After 4 months trial period
Occupational PA,House hold PA and transportation PA are calculated.They are added together and divided with number of days involved to calculate total physical activity in calory/day.Log transformation of data done.Higher value means better effectiveness of BCC.minimum 150 and maximum 374
Domains of Total Physical Activity(Calories/Day) After Intervention in Intervention Group and Control Group
时间窗: at the end of 4 months-October
After intervention, total physical activity in calories/day calculated by adding domains.Total PA=house hold physical activity+transportation PA+occupational PA+leisure time PA.Physical activity measured in minutes and then converted into metabolic equivalent task- score (MET score) using a "standardised" PA questionnaire for moderate \& heavy physical activity for 1 week and calculated average for one day by dividing with number of active days.Sedentary activity measure two MET, light PA=3.5 MET.moderate PA= 4 to 6.5 MET are measured under four domains of PA and is converted into caloric expenditure using formula 0.0175 Kcal x MET of specific activity x body Weight. METS of specific activity is given by Compendium of physical activities- minimum zero calories and maximum 374.81 calories.Higher score means better outcome, better physically active due to effectiveness of intervention
次要结局
- glycosylated hemoglobin(At the end of 4 months -October)
- Glycosylated Haemoglobin(HbA1c)(At the end of 4 months)
研究者
Dr.Rose Davy.C
Assistant professor in Physiology ,Govt medical college,Kerala.MPhil in Clinical epidemiology student
Thiruvananthapuram Medical College