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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03028714
Other study ID # FREC 2016-04-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 26, 2017
Est. completion date March 30, 2018

Study information

Verified date August 2018
Source Kingston University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Metabolic risk factors, such as central obesity, increase the risk of chronic diseases in adulthood and are prevalent in many university students. Increasing the knowledge about healthy nutrition and physical activity can positively impact students' lifestyle and prevent weight gain. This study aims to investigate the impact of online educational methods on nutrition knowledge, dietary habits, BMI, and physical activity in a sample of university students in the UK. Anthropometric measurements will be assessed and questionnaires will be completed at the beginning and at the end of the study. Written consent will be sought, the voluntary nature of participation will be emphasized while anonymity and confidentiality will be strictly maintained.


Description:

The intervention is a randomized-controlled trial with two data collection points: one at the beginning and one at the end of the study. The study will include healthy students from two UK Universities, who they will be randomly assigned either to the intervention or to the control group. Participants in both groups will be asked to undertake measurements and complete questionnaires before and after the study. Measurements include the assessment of BMI, body fat, lean mass, waist-to-hip ratio, systolic and diastolic blood pressure and blood glucose. In addition, nutrition knowledge and dietary habits will be estimated using online questionnaires as well as the level of physical activity using the IPAQ questionnaire and pedometers. Participants in the intervention group will receive access to an educational website including information about fruit and vegetables, fat, sugars, fast-food, meat, salt, meals and snacks, food labels, exercise, and alcohol. Each category will be linked to an online quiz-game that will include questions related to the topic. Students will be asked to play the games as much as they want to improve their knowledge scores. Access to the website and the games will be available for 10 weeks. Participants in the control group will receive no intervention. After 10 weeks, participants will be asked to undertake the same measurements and complete the same questionnaires as they did in the beginning of the study. The study aims to investigate the effectiveness of an online educational intervention, using game elements, on the level of nutrition knowledge of students, as well as, whether any changes in knowledge impact changes in dietary habits, physical activity and weight-related factors.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date March 30, 2018
Est. primary completion date March 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 34 Years
Eligibility Inclusion Criteria:

- Currently studying at Kingston University, London or at St George's, University of London, as an undergraduate or postgraduate student or undertaking research within one of the two organizations.

- Aged between 18 and 34 years.

- Generally, in good health.

Exclusion Criteria:

- Not currently studying at Kingston University, London or at St George's, University of London.

- Less than 18 or more than 34 years old.

- Suffering a long-term disease or condition that requires a special treatment or diet.

- Suffering a mobility impairment or injury that doesn't allow undertaking moderate physical activity.

- Pregnant or breast-feeding.

Study Design


Related Conditions & MeSH terms

  • Health Knowledge, Attitudes, Practice

Intervention

Behavioral:
Technology-based nutrition education
All participants will undertake anthropometric measurements and assessments of blood pressure and blood glucose. They will be also asked to complete online questionnaires with regards to nutrition and physical activity. Participants in the intervention group will receive additional access to a website, providing information about nutrition topics including alcohol and physical activity. Through the website participants will be asked to play online quiz-games related to the nutrition topics. Each play will include game elements such as time, point collection and graphics. Participants will be asked to play the games as much as they want to improve their scores and to use the website as a reference tool.

Locations

Country Name City State
United Kingdom Kingston University, London & St George's, University of London London

Sponsors (3)

Lead Sponsor Collaborator
Kingston University King's College London, St George's, University of London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. — View Citation

Kliemann N, Wardle J, Johnson F, Croker H. Reliability and validity of a revised version of the General Nutrition Knowledge Questionnaire. Eur J Clin Nutr. 2016 Oct;70(10):1174-1180. doi: 10.1038/ejcn.2016.87. Epub 2016 Jun 1. — View Citation

Leppälä J, Lagström H, Kaljonen A, Laitinen K. Construction and evaluation of a self-contained index for assessment of diet quality. Scand J Public Health. 2010 Dec;38(8):794-802. doi: 10.1177/1403494810382476. Epub 2010 Sep 16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Level of nutrition knowledge (score in units) The level of nutrition knowledge will be assessed using the General Nutrition Knowledge Questionnaire (GNKQ) (Kliemann et al., 2016). The GNKQ includes questions with multiple choice answers, presented in 4 sections: section 1 is related to dietary recommendations, section 2 is related to food groups, section 3 is related to health food choices and section 4 is related to diet, disease and weight association. Each correct answer gets a point (otherwise null) and the maximum score is 88 for the overall questionnaire, 18 for section 1, 36 for section 2, 13 for section 3 and 21 for section 4. One year
Secondary Dietary habits (score in units) Dietary habits will be assessed using the questionnaire of Leppälä, J. et al. (2010). The questionnaire includes 18 questions in relation to whole grain products, fat containing foods, dairy products, vegetables and fruits, sugar and meal pattern. A scoring system is provided as a manual to calculate the total score based on the answer given to each question. The total score represents diet quality (Index of Diet Quality) and can be ranged from 0-15, with 9 or less points indicating a poor diet quality. One year
Secondary Physical activity [vigorous activity (days/week, minutes/week), moderate activity (days/week, minutes/week), walking (days/week, minutes/week), sitting time (minutes/week)]. Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ-short) (Craig et al., 2003). The questionnaire includes questions regarding 1) days per week and time (minutes) spent on one of those days doing vigorous activity, 2) days per week and time (minutes) spent on one of those days doing moderate activity, 3) days per week and time (minutes) spent on one of those days walking and 4) time (minutes) spent the last week sitting on a week day. One year
Secondary Physical activity (number of steps/week). Pedometers will be used to calculate the amount of physical activity by counting daily number of steps. One year
Secondary Body Mass Index (BMI) (kg/m2) BMI (kg/m2) will be estimated after measuring body weight (kg), using an analog scale and height (in meters), using a stadiometer. 1 year
Secondary Body fat (%) Body fat (%) will be estimated using a TANITA body fat analyzer. 1 year
Secondary Lean mass (kg) Lean mass (kg) will be estimated using a TANITA body fat analyzer. 1 year
Secondary Waist-to-hip ratio (WHR) To calculate waist-to-hip ratio a measuring tape will be used to measure waist circumference (cm) and hip circumference (cm) separately. Waist circumference (cm) will be measured at the midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the mid axillary line. Hip circumference (cm) will be measured at the largest circumference of the buttocks. 1 year
Secondary Blood pressure (mmHg) Systolic (mmHg) and diastolic (mmHg) blood pressure will be measured using an electronic sphygmomanometer. The participant will be in a relaxed, quiet room at a comfortable temperature and a short period of 5 minutes rest will precede the measurement.The measurement will be undertaken twice. 1 year
Secondary Blood glucose (mmol/l) Blood glucose levels (mmol/l) will be measured by finger pricking using a blood glucose meter. The participant will be asked to be fasted. 1 year
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