Prevention of type 2 diabetes mellitus through educational intervention for adolescents at risk in high schools in Jordan
| ISRCTN | ISRCTN38144270 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38144270 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/07/2014
- Registration date
- 29/07/2014
- Last edited
- 30/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Type 2 diabetes (T2DM) happens when the body does not make enough insulin to work properly, or when the bodys cells dont react to the insulin properly (insulin resistance). It can cause serious long-term health problems such as blindness, kidney failure, leg amputations, heart disease and stroke. People are more likely to develop the disease if they are overweight or obese, do little exercise and eat an unhealthy diet. Eating healthily, losing weight (if overweight) and regular exercise can all help in controlling symptoms of T2DM and actually preventing the disease from developing. The purpose of this study was to measure the effect of a lifestyle education program designed to prevent T2DM on adolescents in Jordan in danger of developing the condition.
Who can participate?
Adolescents between 12-18 years of age that are visually overweight, not diagnosed with T2DM and have a normal fasting blood glucose level (a measure of how much sugar there is in the blood)
What does the study involve?
Participants are randomly allocated to one of two groups. The intervention group participate in a lifestyle education program. The program is designed to help participants make healthy diet choices and increase the amount of exercise that they do, supported by teaching them to believe that they are actively able to make these changes (though a technique called social cognitive theory self-efficacy). Parental and school staff support is provided. The program includes group education lessons and lifestyle advice. Information on the risks associated with T2DM and how to prevent the disease from developing are offered by each participants school. A 12 week individual guide on nutrition, physical exercise and healthy shopping is then provided together with information on social cognitive theory (self-efficacy). Each participant is then monitored and supported over the next three months though fortnightly meetings and by phone. Participants in the control group are offered education on diet and exercise, social cognitive theory (self-efficacy) and provided with the written materials for a 12 week self-treatment course. At the end of the program, the weight of all participants and their fasting blood glucose levels are measured and compared to those before the trial.
What are the possible benefits and risks of participating?
Participation in the lifestyle program has the potential to alter peoples behaviors to prevent T2DM. There are no possible risks as the trial does not involve drugs or any invasive procedures.
Where is the study run from?
Al-Zaytoonah University of Jordan (Jordan)
When is the study starting and how long is it expected to run for?
October 2011 to October 2012
Who is funding the study?
Al-Zaytoonah University of Jordan (Jordan)
Who is the main contact?
Dr Nihaya Al-Sheyab
Jood1965@yahoo.com
Contact information
Scientific
Al-Zaytoonah University of Jordan
P.O.Box 130 Amman 11733 Jordan
Telephone: 00962-6-4291511
Fax: 00962-6-4291432
Amman
11733
Jordan
Study information
| Study design | Single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effectiveness of a 12-week early intervention for Jordanian adolescents at risk for Type 2 diabetes using lifestyle change and self efficacy: Randomized controlled trial |
| Study objectives | 1. The reduction in weight in three months is significantly greater in the group receiving intervention. 2.The fasting blood glucose levels reduction is significantly greater in the intervention group in three months. 3. There will be significantly greater improvement in nutritional habits in the group receiving intervention in three months, considering the gender, genetic risk factors and parental educational level. 4. There will be significantly increased physical activity in the intervention group in three months, considering the gender, genetic risk factors and parental educational level. |
| Ethics approval(s) | 1. Human Research Ethics Committees of the University of the Sunshine Coast, Aug. 2011 ref 3/10/37101. 2. Jordanian Ministry of Education, Sept. 2011, ref. S/11/351 . |
| Health condition(s) or problem(s) studied | Overweight or obese adolescents at high risk for type 2 diabetes mellitus |
| Intervention | Participants were randomly allocated into one of two groups. 1. Group A - intervention group 2. Group B - control group The intervention was a program of lifestyle education to support participants to select a healthy diet and increase physical activity supported by social cognitive theory-self efficacy to reduce weight and fasting blood glucose with the aim of preventing type 2 diabetes mellitus (T2DM) in adolescents. This was achieved through self-care supported by parental supervision with school staff enabling the study. The key components were group information/education, lifestyle advice for improvement and strategies to achieve the desired outcome, provided at school meetings with Group A participants and their parents. Essential information was given at the participants schools on T2DM risks, outcomes andcomplications of developing T2DM and prevention using diet, exercise and self efficacy . Following this, an adapted 12-week individual guide on nutrition, physical activity and healthy shopping was provided together with an explanation of social cognitive theory (self-efficacy) to assist and support adherence with the program. The following three months included monitoring and assistance on demand for participants at fortnightly meetings or by phone. At the end of the intervention the weight and fasting blood glucose measures were repeated in the school environments for comparison. Following this, surveys were conducted to evaluate and analyse outcomes/changes. Group B participants were told of the purpose of the intervention were offered education on diet and exercise, social cognitive theory (self-efficacy) to help in adherence, and provided with the written materials for a 12 weeks self-treatment guide |
| Intervention type | Other |
| Primary outcome measure | Reducing the risk of developing T2DM by maintaining lifestyle changes is proposed to reduce youth T2DM development. Such a long-term result could not be measured in this time-limited study, but it provides a basis for future long-term intervention studies. The key question was: Will an educational intervention with follow-up support over 3 months reduce modifiable risk factors in lifestyle to prevent the development of T2DM in Jordanian adolescents? Factors considered and analysed included gender, diabetes mellitus family history and parental education levels. Two primary outcome measures were identified and analyzed: 1. Weight 2. Fasting blood glucose (FBG) |
| Secondary outcome measures | 1. Diet 2. Physical activity All primary and secondary outcomes were measured at baseline and 12 weeks after (upon completion of the intervention). |
| Overall study start date | 01/10/2011 |
| Completion date | 01/10/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | 1. Consenting male and female adolescents 12-18 years 2. Visually overweight/obese 3. Not diagnosed with type 2 diabetes 4. Demonstrating normal fasting blood glucose (FBG) level of 60-125mg/dl |
| Key exclusion criteria | FBG that is more than 126 mg/dl or 6.99 mmol/l |
| Date of first enrolment | 01/10/2011 |
| Date of final enrolment | 01/10/2012 |
Locations
Countries of recruitment
- Jordan
Study participating centre
11733
Jordan
Sponsor information
University/education
Amman Jordan
Al-Zaytoonah University of Jordan
P.O.Box 130 Amman 11733 Jordan
Telephone: 00962-6-4291511
Fax: 00962-6-4291432
Email: president@zuj.edu.jo
Amman
11733
Jordan
"ROR" |
https://ror.org/04a5b0p13 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
