ObesityNCT04152213
The Effects of Low Glycemic Index (GI) Diet on Cardiometabolic Outcomes Among Obese Chinese Adults
A study testing Low GI diet in people with Obesity and Central Obesity, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The aim of this study is to investigate the effects and the acceptability of low GI diet versus a conventional healthy diet on the BMI and other cardiometabolic risk factors of obese Chinese adults in Hong Kong. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Central Obesity
- What is being tested?
- Low GI diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI >25.0 kg/m2;
- Waist circumference > 90 cm for men and > 80 cm for women;
- Aged eighteen years or older;
- Chinese ethnicity;
- Can be contacted by telephone;
- Have the ability to read and understand Chinese; and
- Can provide informed consent.
Who cannot join
- Concurrently participating in any other clinical trials;
- Concurrently participating in weight control programs;
- Concomitant intake of weight reduction drugs;
- Use of calorie restricted diet or specialized diets which contraindicated with low GI diet;
- Have gastrointestinal problems that would prevent them from following the prescribed diet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Low Glycemic Index (GI) Diet on Cardiometabolic Outcomes Among Obese Chinese Adults: A Randomized Controlled Trial
The aim of this study is to investigate the effects and the acceptability of low GI diet versus a conventional healthy diet on the BMI and other cardiometabolic risk factors of obese Chinese adults in Hong Kong.
Read the detailed description
29.9% of persons aged 15-84 in Hong Kong are obese. Obesity poses significant detrimental consequences for one's health. Obese patients have an increased risk of mortality when compared with people with normal BMI. Obesity results in arterial hypertension, hyperlipidaemia, heart disease and type 2 diabetes. Low GI diets have been investigated for their impact on weight control. Evidence showed that low GI diets were effective in lowering body mass index. However, the evidence was usually generated from Western populations, thus excluding the influence of Chinese culture on diet.The aim of this study is to investigate the effects and the acceptability of low GI diet versus a conventional healthy diet on the BMI and other cardiometabolic risk factors of obese Chinese adults in Hong Kong.
A prospective, two-arm randomized-controlled trial will be conducted to examine the effect of a low GI diet education program on cardiometabolic outcomes in Chinese adults with obesity. The intervention group will receive a low GI diet education, including a one-off, 60-minute, face-to-face, educational session conducted by the research nurse for GI knowledge input. An informational booklet will be given out during the education session.Three follow-up telephone calls of fifteen minutes will be conducted by the research nurse at the 2nd, 5th , and 8th weeks after completing the face-to-face education session. While the control group will receive an education pamphlets on obesity and balanced diet.Three follow-up telephone calls of fifteen minutes will be conducted by the research nurse at the 2nd, 5th , and 8th weeks after receiving the pamphlets.
At baseline, demographic and clinical data, including BMI, waist circumference, body fat, blood pressure, fasting plasma glucose, HbA1c, lipid profile, 3-day food diary, International Physical Activity Questionnaire (IPAQ-C), and the sense of fullness will be collected.
On the 12th week, data about the BMI, waist circumference, body fat, blood pressure, fasting plasma glucose, HbA1c, lipid profile, 3-day food diary, IPAQ-C, and the sense of fullness and a questionnaire on the evaluation process will be collected.
- Conditions
- Obesity, Central Obesity
- Being tested
- Low GI diet
- Keywords
- Chinese adult, obesity, low glycemic index diet, cardiometabolic
- Medical subject headings
- Obesity, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low GI dietBehavioural
This educational session will cover information on obesity, complications of obesity, the benefit of weight loss, the glycemic index and its associated low GI diet, a food-exchange table including high- to low-GI foods, and self-decision in food choices. The dietary advice will be based on the standard food pyramid for the conventional Chinese diet as promoted by the Hong Kong Department of Health, with an emphasis on the selection of low-GI products. Practical tips will be given such as the selection of low-GI rice and rice products, the impact of cooking methods (including cooking time, cooking conditions, and cooking liquid volume) on rice GI, intervention to reduce the GI of rice, and listing low-GI food options and meal plans.
| Study group | Role | What they receive |
|---|---|---|
| Low GI diet group | Experimental | The components of the Low GI diet group include:
(1) A one-off, 60-minute, face-to-face, educational session conducted by the research nurse for GI knowledge input. (2) An informational booklet will be given out during the education session. (3) Three follow-up telephone calls of fifteen minutes will be conducted by the research nurse at the 2nd, 5th , and 8th weeks after completing the face-to-face education session. Receives: Behavioral: Low GI diet |
| Control group | Placebo comparator | The components of the control group include:
(1) Pamphlets from the Department of Health about obesity and a balanced diet based on the food pyramid will be distributed. (2)Three follow-up telephone calls of fifteen minutes will be conducted by the research nurse at the 2nd, 5th , and 8th weeks after receiving the pamphlets. Receives: Behavioral: Low GI diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index (BMI)
within- and between-participant changes in BMI, BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m^2, resulting from body mass in kilograms(kg) and body height in metres(m).The body mass and body height will be assessed using an electronic scale and a wall-mounted stadiometer, respectively.
Measured: baseline and 12th week
Secondary outcomes (17)
waist circumference
within- and between-participant changes in waist circumference. Waist circumference will be measured by using the midway point between the top of the hip bone and base of the ribs as a landmark in centimeters(cm) on bare skin at the end of a normal expiration, with arms relaxed at the sides
Measured: baseline and 12th week
body fat
within- and between-participant changes in body fat. Body fat percentage (%) and different body compositions (visceral fat, subcutaneous whole body, subcutaneous trunk, subcutaneous arms, subcutaneous legs) will be assessed by body composition analyser based on the principles of bioelectrical impedance
Measured: baseline and 12th week
blood pressure
within- and between-participant changes in blood pressure. Blood pressure is measured in terms of the systolic pressure over diastolic pressure and is measured in millimeters of mercury (mmHg)
Measured: baseline and 12th week
fasting plasma glucose
within- and between-participant changes in fasting plasma glucose. Fasting plasma glucose will be drawn by venipuncture after an eight-hour overnight. fast for laboratory testing. Fasting plasma glucose is measured in millimoles per liter (mmol/L)
Measured: baseline and 12th week
Hemoglobin A1c (HbA1c)
within- and between-participant changes in HbA1c. HbA1c will be drawn by venipuncture after an eight-hour overnight fast for laboratory testing. HbA1c will be measured in percentage (%)
Measured: baseline and 12th week
Total cholesterol (TC)
within- and between-participant changes in Total cholesterol (TC). It will be drawn by venipuncture after an eight-hour overnight fast. It will be measured in millimoles per liter (mmol/L)
Measured: baseline and 12th week
HDL-cholesterol (HDL-C)
within- and between-participant changes in HDL-cholesterol (HDL-C). It will be drawn by venipuncture after an eight-hour overnight fast. It will be measured in millimoles per liter (mmol/L)
Measured: baseline and 12th week
LDL-cholesterol (LDL-C)
within- and between-participant changes in LDL-cholesterol (LDL-C) level. It will be drawn by venipuncture after an eight-hour overnight fast. It will be measured in millimoles per liter (mmol/L)
Measured: baseline and 12th week
Triglycerides level (TG)
within- and between-participant changes in triglycerides level (TG). It will be drawn by venipuncture after an eight-hour overnight fast. It will be measure in millimoles per liter (mmol/L)
Measured: baseline and 12th week
dietary glycemic index (GI) value
within- and between-participant changes in dietary GI value. The dietary GI value for each participant will be calculated by summing the products of the percentage contribution of each individual food to daily available carbohydrate intake multiplied by the food's GI value.
Measured: baseline and 12th week
dietary glycemic load
within- and between-participant changes in dietary glycemic load. The dietary GL will be calculated by multiplying the dietary GI by the total amount of daily available carbohydrate intake. Dietary will be measured as g per 1000 kcal
Measured: baseline and 12th week
calories
within- and between-participant changes in calories [kcal] intake
Measured: baseline and 12th week
carbohydrates
within- and between-participant changes in carbohydrates[g] intake
Measured: baseline and 12th week
fat
within- and between-participant changes in fat [g] intake
Measured: baseline and 12th week
proteins
within- and between-participant changes in proteins[g] intake
Measured: baseline and 12th week
fiber
within- and between-participant changes in fiber[g] intake
Measured: baseline and 12th week
the sense of fullness as dietary satiety
within- and between-participant changes in the sense of fullness as dietary satiety. The sense of satiety with diet will be assessed by a visual analogue scale (VAS) consisting of a 100mm long line with the left anchor representing "very hungry" and the right anchor representing "very full." The satiety premeal, postmeal and 2 hours postmeal will be measured.
Measured: baseline and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Mar 2021
- Primary completion15 Dec 2021
- Study completion31 Dec 2021
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 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
- Model description
- prospective, two-arm randomized-controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leung Lai Yin, Chinese University of Hong Kong
- Investigators
- Sek Ying Chair, Study director, The Nethersole School of Nursing, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152213
- Sponsor's protocol ID
- 00000000
- Status last verified
- Mar 2022
- First submitted
- 30 Oct 2019
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leung LY, Sit JWH, Gao R, Chair SY. Effects of a culturally tailored low-glycaemic index dietary educational intervention on reducing cardiometabolic risk among Chinese adults with obesity: a randomized controlled trial. Eur J Cardiovasc Nurs. 2024 Oct 21;23(7):789-799. doi: 10.1093/eurjcn/zvae062.
PubMed 38726646
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Low Glycemic Index (GI) Diet on Cardiometabolic Outcomes Among Obese Chinese Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04152213
- Acronym / sponsor ID
- 00000000
- Conditions
- Obesity, Central Obesity
- Keywords
- Chinese adult, obesity, low glycemic index diet, cardiometabolic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the effects and the acceptability of low GI diet versus a conventional healthy diet on the BMI and other cardiometabolic risk factors of obese Chinese adults in Hong Kong.
Detailed description
29.9% of persons aged 15-84 in Hong Kong are obese. Obesity poses significant detrimental consequences for one's health. Obese patients have an increased risk of mortality when compared with people with normal BMI. Obesity results in arterial hypertension, hyperlipidaemia, heart disease and type 2 diabetes. Low GI diets have been investigated for their impact on weight control. Evidence showed that low GI diets were effective in lowering body mass index. However, the evidence was usually generated from Western populations, thus excluding the influence of Chinese culture on diet.The aim of this study is to investigate the effects and the acceptability of low GI diet versus a conventional healthy diet on the BMI and other cardiometabolic risk factors of obese Chinese adults in Hong Kong.
A prospective, two-arm randomized-controlled trial will be conducted to examine the effect of a low GI diet education program on cardiometabolic outcomes in Chinese adults with obesity. The intervention group will receive a low GI diet education, including a one-off, 60-minute, face-to-face, educational session conducted by the research nurse for GI knowledge input. An informational booklet will be given out during the education session.Three follow-up telephone calls of fifteen minutes will be conducted by the research nurse at the 2nd, 5th , and 8th weeks after completing the face-to-face education session. While the control group will receive an education pamphlets on obesity and balanced diet.Three follow-up telephone calls of fifteen minutes will be conducted by the research nurse at the 2nd, 5th , and 8th weeks after receiving the pamphlets.
At baseline, demographic and clinical data, including BMI, waist circumference, body fat, blood pressure, fasting plasma glucose, HbA1c, lipid profile, 3-day food diary, International Physical Activity Questionnaire (IPAQ-C), and the sense of fullness will be collected.
On the 12th week, data about the BMI, waist circumference, body fat, blood pressure, fasting plasma glucose, HbA1c, lipid profile, 3-day food diary, IPAQ-C, and the sense of fullness and a questionnaire on the evaluation process will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, two-arm randomized-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Low GI diet group | Experimental | Behavioral: Low GI dietThe components of the Low GI diet group include: (1) A one-off, 60-minute, face-to-face, educational session conducted by the research nurse for GI knowledge input. (2) An informational booklet will be given out during the education session. (3) Three follow-up telephone calls of fifteen minutes will be conducted by the research nurse at the 2nd, 5th , and 8th weeks after completing the face-to-face education session. |
| Control group | Placebo comparator | Behavioral: Low GI dietThe components of the control group include: (1) Pamphlets from the Department of Health about obesity and a balanced diet based on the food pyramid will be distributed. (2)Three follow-up telephone calls of fifteen minutes will be conducted by the research nurse at the 2nd, 5th , and 8th weeks after receiving the pamphlets. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- BMI >25.0 kg/m2;
- Waist circumference > 90 cm for men and > 80 cm for women;
- Aged eighteen years or older;
- Chinese ethnicity;
- Can be contacted by telephone;
Key exclusion criteria (5 listed)
- Concurrently participating in any other clinical trials;
- Concurrently participating in weight control programs;
- Concomitant intake of weight reduction drugs;
- Use of calorie restricted diet or specialized diets which contraindicated with low GI diet;
- Have gastrointestinal problems that would prevent them from following the prescribed diet.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low GI dietThis educational session will cover information on obesity, complications of obesity, the benefit of weight loss, the glycemic index and its associated low GI diet, a food-exchange table including high- to low-GI foods, and self-decision in food choices. The dietary advice will be based on the standard food pyramid for the conventional Chinese diet as promoted by the Hong Kong Department of Health, with an emphasis on the selection of low-GI products. Practical tips will be given such as the selection of low-GI rice and rice products, the impact of cooking methods (including cooking time, cooking conditions, and cooking liquid volume) on rice GI, intervention to reduce the GI of rice, and listing low-GI food options and meal plans. | Behavioural | Control group, Low GI diet group |
Primary outcome
Body mass index (BMI)
Time frame: baseline and 12th week
within- and between-participant changes in BMI, BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m^2, resulting from body mass in kilograms(kg) and body height in metres(m).The body mass and body height will be assessed using an electronic scale and a wall-mounted stadiometer, respectively.
17 secondary outcomes
waist circumference
Time frame: baseline and 12th week
body fat
Time frame: baseline and 12th week
blood pressure
Time frame: baseline and 12th week
fasting plasma glucose
Time frame: baseline and 12th week
Hemoglobin A1c (HbA1c)
Time frame: baseline and 12th week
Total cholesterol (TC)
Time frame: baseline and 12th week
HDL-cholesterol (HDL-C)
Time frame: baseline and 12th week
LDL-cholesterol (LDL-C)
Time frame: baseline and 12th week
Triglycerides level (TG)
Time frame: baseline and 12th week
dietary glycemic index (GI) value
Time frame: baseline and 12th week
dietary glycemic load
Time frame: baseline and 12th week
calories
Time frame: baseline and 12th week
carbohydrates
Time frame: baseline and 12th week
fat
Time frame: baseline and 12th week
proteins
Time frame: baseline and 12th week
fiber
Time frame: baseline and 12th week
the sense of fullness as dietary satiety
Time frame: baseline and 12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Derived from this study: PubMed 38726646Leung LY, Sit JWH, Gao R, Chair SY. Effects of a culturally tailored low-glycaemic index dietary educational intervention on reducing cardiometabolic risk among Chinese adults with obesity: a randomized controlled trial. Eur J Cardiovasc Nurs. 2024 Oct 21;23(7):789-799. doi: 10.1093/eurjcn/zvae062.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sek Ying Chair study director
The Nethersole School of Nursing, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low GI diet in people with Obesity and Central Obesity, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (BMI) (time frame: baseline and 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04152213, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.