The Effects of Low Glycemic Index (GI) Diet on Cardiometabolic Outcomes Among Obese Chinese Adults

NCT ID: NCT04152213

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Low GI diet group

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.

Group Type: EXPERIMENTAL

Low GI diet

Intervention Type: BEHAVIORAL

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.

Control group

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.

Group Type: PLACEBO_COMPARATOR

Low GI diet

Intervention Type: BEHAVIORAL

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.

Interventions

Low GI diet

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. BMI >25.0 kg/m2;

2. Waist circumference > 90 cm for men and > 80 cm for women;

3. Aged eighteen years or older;

4. Chinese ethnicity;

5. Can be contacted by telephone;

6. Have the ability to read and understand Chinese; and

7. Can provide informed consent.

Exclusion Criteria

1. Concurrently participating in any other clinical trials;

2. Concurrently participating in weight control programs;

3. Concomitant intake of weight reduction drugs;

4. Use of calorie restricted diet or specialized diets which contraindicated with low GI diet;

5. Have gastrointestinal problems that would prevent them from following the prescribed diet.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Leung Lai Yin

Doctoral Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sek Ying Chair

Role: STUDY_DIRECTOR

The Nethersole School of Nursing, The Chinese University of Hong Kong

Locations

District Councilor Office

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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.

Reference Type: DERIVED

PMID: 38726646 (View on PubMed)

Other Identifiers

00000000

Identifier Type: -

Identifier Source: org_study_id