Adolescence ObesityNCT01278563
A Trial to Investigate the Impact of a Low Glycemic Index (GI) Diet on Body Mass Index and Obesity Related Cardiovascular and Hormonal Factors in Chinese Adolescents
A study testing Low glycemic index diet in people with Adolescence Obesity, run by Chinese University of Hong Kong at 2 sites in 2 countries.
Trial summary
Epidemiological studies suggest a role for a low glycemic index (GI) diet in the management of obesity and associated metabolic risks including diabetes. However, evidence from long-term, randomized controlled trials exploring the relationship between low GI diet, weight reduction and glycemia, particularly in… Read more about this study
- Who is it for?
- Ages 15 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescence Obesity
- What is being tested?
- Low glycemic index diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Feb 2011to 30 Oct 2013
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- School children aged 15 or above
- Male or female of Chinese ethnicity
- Body mass index >/= 95th percentile of Hong Kong local age- and sex-specific reference
- No major medical illness
- Not on any chronic medications
- Post-pubertal as ascertained by clinical assessment by endocrinologist
- Willingness to give written informed consent by participants and his/her parents/guardian
Who cannot join
- Concurrent participation in any clinical trial, dietary intervention or weight loss program
- Concomitant intake of weight reducing agent
- Active and uncontrolled endocrine diseases including hypo- or hyperthyroidism, Cushing's syndrome, diabetes mellitus, etc.
- Significant renal impairment, defined as serum creatinine >150 umol/L and/or estimated glomerular filtration rate <60ml/min/1.73m2
- Significant liver impairment, defined as >2 times upper limit of alanine aminotransferase and asparate aminotransferase levels
- Gastrointestinal problems that would prevent them from following the test diets
Show all 9Show fewer
- Active malignant disease
- Pregnant or lactating
- Any medical illness or condition including known non-compliance, as judged by the investigators as ineligible to participate the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Hong Kong1 site
Clinical Trial Centre, The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong
About this study
Official title: A Randomized Controlled Trial to Investigate the Impact of a Low Glycemic Index (GI) Diet on Body Mass Index and Obesity Related Cardiovascular and Hormonal Factors in Chinese Adolescents
Epidemiological studies suggest a role for a low glycemic index (GI) diet in the management of obesity and associated metabolic risks including diabetes. However, evidence from long-term, randomized controlled trials exploring the relationship between low GI diet, weight reduction and glycemia, particularly in children and adolescents, is lacking. Modern food-processing technology has produced many food products with high GI which may contribute to the burgeoning epidemic of obesity worldwide. Since dietary habits are shaped in early life, adolescence is a critical period to educate our young people to acquire a healthy eating habit to prevent obesity.
The investigators hypothesized that, in Chinese adolescents, low GI diet results in greater reduction in body mass index and body fat percentage, enhanced insulin sensitivity and favorable changes of cardiometabolic risk factors compared to conventional diet after 12 months of intervention.
This study is a randomized controlled trial of a low GI (<55) versus conventional Chinese diet (GI>/=70) in adolescents (12-month intervention followed by a 6-month observational period) to study; 1) the changes in body mass index and obesity associated changes in cardiometabolic profile; 2) the underlying hormonal factors associated with these changes.
Read the detailed description
This is a 12-month randomized controlled dietary interventional trial followed by a 6-month observational period. The objectives of this study include:
- To study changes of body mass index, body fat percentage, insulin secretion, insulin resistance and obesity associated cardiometabolic factors;
- To explore underlying neurohormonal mechanisms associated with these changes in both short- and long-term.
- Conditions
- Adolescence Obesity
- Being tested
- Low glycemic index diet
- Keywords
- Low Glycemic Index Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycemic index dietBehavioural
dietitian interview and counselling for the low glycemic index diet group
| Study group | Role | What they receive |
|---|---|---|
| Counseling on low glycemic index diet | Active comparator | One arm would be counseling on low glycemic index diet, while another arm is the conventional diet Receives: Behavioral: Low glycemic index diet |
| Control (Usual Care) | No intervention | Conventional diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass index
body mass index= body weight (kg) divided by square of body height (m2)
Measured: change from baseline to 12 months
Secondary outcomes (1)
other parameters of body composition
- waist circumference
- body fat percentage
Measured: change from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study start15 Feb 2011
- Primary completion30 Oct 2013
- Study completion30 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescence ObesityStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Pik Shan KONG, Chinese University of Hong Kong
- Investigators
- Alice Kong, FRCP, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278563
- Sponsor's protocol ID
- RGC467410
- Status last verified
- Jan 2011
- First submitted
- 18 Jan 2011
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Kong AP, Choi KC, Chan RS, Lok K, Ozaki R, Li AM, Ho CS, Chan MH, Sea M, Henry CJ, Chan JC, Woo J. A randomized controlled trial to investigate the impact of a low glycemic index (GI) diet on body mass index in obese adolescents. BMC Public Health. 2014 Feb 19;14:180. doi: 10.1186/1471-2458-14-180.
PubMed 24552366