Home » Trials » SLCTR/2018/017


A lifestyle modification intervention on selected cardiovascular risk factors in overweight and obese women aged 35-44 years in Medical Officer of Health areas Bandaragama and Horana -

SLCTR Registration Number

SLCTR/2018/017


Date of Registration

11 Jun 2018

The date of last modification

Aug 13, 2018



Application Summary


Scientific Title of Trial

A lifestyle modification intervention on selected cardiovascular risk factors in overweight and obese women aged 35-44 years in Medical Officer of Health areas Bandaragama and Horana


Public Title of Trial

A lifestyle modification intervention on selected cardiovascular risk factors in overweight and obese women aged 35-44 years in Medical Officer of Health areas Bandaragama and Horana


Disease of Health Condition(s) Studied

Overweight, obesity, hypertention


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

None


Any other number(s) assigned to the trial and issuing authority

Ethics Review reference number- NO-P/21/01/2018


Trial Details


What is the research question being addressed?

How effective is a lifestyle modification intervention, which is developed using self-efficacy strategies in social cognitive theory and self-management strategies, for overweight and obesity among 35-44 year old women?


Type of study

Interventional


Study design

Allocation

Non-randomized controlled trial


Masking

Single blinded


Control

Standard therapy


Assignment

Parallel


Purpose

Prevention


Purpose


Intervention(s) planned

  1. The study setting is in the Kalutara District, Sri Lanka. The intervention will be done in Medical officer of Health area Bandaragama and The control arm study participants will be selected from Medical officer of Health area in Horana

  2. Randomly selected 35 Grama Niladari (GN) divisions will be selected from each MOH during the descriptive study component of this study. Among 35 GN divisions, using simple random method (WINPEPI soft ware) only 20 GN divisions from each MOH area, will be selected for both intervention and control arm. Among these selected 20 GN divisions first 16 eligible participants from each GN division who are obese and overweight will be selected for the study.

  3. The proposed intervention is for six months duration. It is based on improving the awareness and knowledge of prevention of NCD through lifestyle modification in diet and physical activity. This will be delivered in 6 lecture series for first 3 months of the intervention. Each lecture series is of one hour duration. Themes of the lectures are based on how to improve self-efficacy related to diet and physical activity. Practical session of physical activity training, how healthy behavior can be improved with healthy choices, promotion of home gardening and address their barriers to have healthy choices in life. Self- efficacy session will delivered by PI. Physical activity session will be delivered through trained person in physical activity, healthy behavior and healthy choices will be delivered by Health Education officer. Active member in mother support group in the area will demonstrate healthy cooking choices with locally available food items. Promotion of home garden will be delivered by Agricultural Inspector attached to “GOVI JANA SEWA” center in Bandaragma. Barriers to healthy lifestyle will be addressed by PI. Lecture sessions are planned as 2 lecture series for each month. End of each lecture session, group counseling will be conducted for 30 minutes. One to one counseling will be done to participants who have difficulty in achieving their target goals at the end of 3rd month. 2 individual sessions are planned for those individual at 4th and 5th month of the intervention. Each counseling session is planned for 30 minutes. From the first day session onwards a walking group will be formed to improve their physical activity level.

  4. Participants in the control arm will receive services delivered through Healthy life style centers in the area as it is available through the current service centers

  5. Participants in intervention arm cannot be blinded because they understand that an intervention is being conducted. Participants in the control arm are not aware of what is being done in the intervention arm. To avoid contamination, the proposed intervention is planned only in MOH-Bandaragama, while the control arm is from MOH-Horana. Post-intervention data collectors will be not aware of the intervention/ control status. The data analysis will be done by an independent statistician who will be blind to the intervention. Therefore data collectors and data analysts will be blinded to the intervention status.


Inclusion criteria

  1. Overweight and obese women (BMI between 23 kg/ m2 to 35 kg/ m2) in the age group 35-44 years in the Medical Officer of Health areas (MOH) Bandaragama and Horana registered in the electoral list of 2017.

  2. Persons who are able to communicate in Sinhala will be included

  3. Women who are not planning pregnancy for a minimum one year will be included


Exclusion criteria

  1. Women who are diagnosed with hypothyroidism and other endocrine disorders such as Cushing’s syndrome due to primary and secondary causes.

  2. Any other disease or pathological status that cause enlarged abdomen (malignancy, ascites, uterine detention etc.)

  3. Any other condition that may affect the study subjects to limit the participation in the lifestyle modification programme e.g. valvular heart disease, disability

  4. Pregnant women and lactating women within six months of postpartum.

5.Women who are severely ill or diagnosed as having psychiatric illness



Primary outcome(s)

Mean difference of BMI at baseline and post-intervention follow-up. This will be calculated for both intervention and control arms. Mean difference will be compared between intervention and control arms.


Primary outcome(s) - Time of assessment(s)

All the measures will be taken at the base line and at the end of intervention period of 6 months.


Secondary outcome

1) Self efficacy in eating and physical activity will be measured through mean scores gained by each participants during pre and post intervention using translated and culturally adapted weight Efficacy life style questionnaire short form (WEL-SF) and Exercise self –efficacy questionnaire

(This is one of the component of the proposed study – Validation of above mention tools)

2) Hip and waist circumference ratio (using measuring tape at base line and at the end of intervention)

3) Blood pressure - using mercury sphygmomanometer

4) Physical activity will be measured through Metabolic Equivalent Task (MET) minutes per week and participants will be categorized according to the guidelines developed by the IPAQ research committee. Measurements will be taken pre and post intervention using Interviewer administered Long form-International Physical Activity Questionnaire which is validated to use in Sri-Lanka

5) Portion size of each food item will be assessed in pre and post intervention using recommendations given in Food based dietary guidelines by Nutrition Division- Ministry of Health-Sri Lanka. To assess their portion size will be given 24 hours dietary recall and 7 days food diary at base line and at the end of 6 months.


Secondary outcome(s) - Time of assessment(s)

All the measures will be taken at the base line and at the end of intervention period of 6 months.



Target number/sample size

640 (320 eligible females per arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2018-06-25


Anticipated end date

2019-02-25


Recruitment status

Recruiting


State of ethics review approval

Approved by the Ethics Review Committee of the Faculty of Medicine, University of Kelaniya on 09.01.2018 (Ref. No. P/21/01/2018)


Funding source

Medical Research Institute-Colombo



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Deshani Chandima Kumari Herath
Registrar in Community Medicine
Department of Public Health Faculty of Medicine University of Kelaniya P.O.Box-06 Thalagolla Rd Ragama
Tel: 00129553411
Mob: 0774541622

chandishani11@yahoo.com

Contact Person for Public Queries

Deshani Chandima Kumari Herath
Registrar in Community Medicine
Department of Public Health Faculty of Medicine University of Kelaniya P.O.Box-06 Thalagolla Rd Ragama Supervisor: Dr. KTAA Kasturiratne Senior Lecturer in Public Health Department of Public Health Faculty of Medicine University of Kelaniya
Tel: 00129553411
Mob: 0774541622

chandishani11@yahoo.com


Primary study sponsor/organization

Medical Research Institute
Government Institution
P.O.Box-527, Dr.Danister De silva Mw, Colombo -08
0094 2 693532-34, 0094 2 693527
0094 2 691495
info@mri.gov.lk, health.information@mri.gov.lk, director@mri.gov.lk

Secondary study sponsor (If any)

None