Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Type 2 diabetes (T2DM) happens when the body does not make enough insulin to work properly, or when the body’s cells don’t 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

Trial website

Contact information



Primary contact

Dr Ayman Bani Salameh


Contact details

Al-Zaytoonah University of Jordan
P.O.Box 130 Amman 11733 Jordan
Telephone: 00962-6-4291511
Fax: 00962-6-4291432

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

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 hypothesis

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

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 .

Study design

Single-blinded randomized controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Overweight or obese adolescents at high risk for type 2 diabetes mellitus


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



Not Applicable

Drug names

Primary outcome measures

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 trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants


Participant exclusion criteria

FBG that is more than 126 mg/dl or 6.99 mmol/l

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Al-Zaytoonah University of Jordan

Sponsor information


Al -Zaytoonah University (Jordan)

Sponsor details

Amman Jordan
Al-Zaytoonah University of Jordan
P.O.Box 130 Amman 11733 Jordan
Telephone: 00962-6-4291511
Fax: 00962-6-4291432

Sponsor type




Funder type


Funder name

Al-Zaytoonah University of Jordan (Jordan)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes