CTRI Number	CTRI/2016/11/007457 [Registered on: 09/11/2016] Trial Registered Retrospectively
Last Modified On:	16/11/2019
Post Graduate Thesis	Yes
Type of Trial	Interventional
Type of Study	Preventive Behavioral Other (Specify) [Nutrition behaviour change intervention]
Study Design	Cluster Randomized Trial
Public Title of Study	Effect of community-led, information technology-enabled health promotion interventions on nutrition behaviour of adults
Scientific Title of Study	Effect of community-led, Information Technology-enabled Health Promotion Interventions on Nutrition Behaviour: A Randomised Controlled Trial among Urban Adults
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  JASVIR KAUR  Address  School of Public Health Chandigarh CHANDIGARH 160012 India  Phone  8054246707   Fax  0   Email  jasvirkaur65d@gmail.com
Details Contact Person Scientific Query	Name  Dr Manmeet Kaur  Address  School of Public Health Chandigarh CHANDIGARH 160012 India  Phone  9815071863   Fax  0   Email  mini.manmeet@gmail.com
Details Contact Person Public Query	Name  JASVIR KAUR  Address  School of Public Health Chandigarh CHANDIGARH 160012 India  Phone  8054246707   Fax  0   Email  jasvirkaur65d@gmail.com
Source of Monetary or Material Support	Post Graduate Institute of Medical Education and Research, Chandigarh
Primary Sponsor	Name  Jasvir Kaur  Address  PhD Scholar, School of Public Health, Post Graduate Institute of Medical Education and Research Chandigarh, India. Phone: 8054246707; email: jasvirkaur65d@gmail.com  Type of Sponsor  Other [Own funding (PhD study)]
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Jasvir Kaur  Chandigarh  Department of Community Medicine, School of Public Health, Post Graduate Institute of Medical Education and Research, Chandigarh Chandigarh   8054246707 jasvirkaur65d@gmail.com
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  Institutional Ethics Committee  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Healthy Human Volunteers  Health Promotion Intervention
Intervention / Comparator Agent	Type  Name  Details  Intervention  Information technology-enabled nutrition education   Nutrition education using mobile phone (SMS, WhatsApp), landline phone and internet for "SMART EATING" website and email reminders to promote low-fat, low-sugar and low-salt diet with more vegetables and fruits for six months. In addition, other aids on dietary guidelines in the form of dining table mat, kitchen calendar, shopping card on food label reading guidelines and measuring spoons (5 gram) will be provided. Flip book will be used for training the families.   Comparator Agent  Traditional nutrition promotion  Traditional nutrition promotion through pamphlet on dietary guidelines
Inclusion Criteria	Age From  35.00 Year(s) Age To  70.00 Year(s) Gender  Both  Details  1. Families from low, middle and high-income group housing, residing in study area for 6 months prior to baseline survey. 2. Families having access to information-technology tools such as mobile phone/ landline phone/ internet. 3. Families with adult males and females between 35 and 70 years of age.
ExclusionCriteria	Details  Families which do not have access to any of the information technology tools.
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	Not Applicable
Blinding/Masking	Not Applicable
Primary Outcome	Outcome  TimePoints  Percentage of participants meeting dietary intake guidelines given by National Institute of Nutrition, Hyderabad, India. Difference in fat, sugar, salt, vegetable and fruit intake.   Baseline to endline - 6 months
Secondary Outcome	Outcome  TimePoints  Difference in mean body mass index (BMI), blood pressure, haemoglobin, fasting blood glucose, total serum cholesterol (TC), high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides and 24 hour urinary Sodium excretion estimated from spot urine samples.  Baseline to endline - 6 months
Target Sample Size	Total Sample Size="732" Sample Size from India="732"
Phase of Trial	N/A
Date of First Enrollment (India) Modification(s)	15/05/2016
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details	NIL
Brief Summary	This is a randomised controlled trial comparing the effect of community-led, information technology-enabled nutrition education to promote low fat, low-sugar and low-salt diet with high vegetable and fruit intake among urban adults for 6 months using mobile phone for sending SMS and WhatsApp messages, landline phone and internet for "SMART EATING" website and email reminders and other aids in the form of dining table mat, kitchen calendar, shopping card on food label reading guidelines and measuring spoons (5 gram) against traditional nutrition promotion using pamphlet in control arm. The trial will be conducted in Chandigarh, India.  Aim: The study aims at improving nutrition behaviour among urban adults. Objectives:  1. To find out the knowledge, attitude and practices related to nutrition in urban population. 2. To identify the content, messages, channels and methods of communication for health promotion interventions. 3. To develop health promotion interventions for improving nutrition behaviour of adults in urban area. 4. To determine the effect of health promotion interventions on nutrition behaviour among urban adults. 5. To understand perceptions of participants regarding the effect of intervention on their nutrition behaviour.