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

NCT04152213 | Completed DMC

• 1 other identifier: 00000000
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Central Obesity

Keywords

Chinese adult; obesity; low glycemic index diet; cardiometabolic

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 12th week

Secondary Outcomes (17)

• waist circumference

  baseline and 12th week

• body fat

  baseline and 12th week

• blood pressure

  baseline and 12th week

• fasting plasma glucose

  baseline and 12th week

• Hemoglobin A1c (HbA1c)

  baseline and 12th week

Other Outcomes (2)

• International Physical Activity Questionnaire (IPAQ-C)

  baseline and 12th week

• self-administer questionnaire

  12th week

Study Arms (2)

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.

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.

Behavioral: Low GI diet

Interventions

Low GI diet 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; Low GI diet group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

District Councilor Office

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 38726646 DERIVED

MeSH Terms

Conditions

Obesity; Obesity, Abdominal

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sek Ying Chair

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistants who have no knowledge about group allocation and study's objectives, will collected the post-intervention data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student

Model Details: prospective, two-arm randomized-controlled trial

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 5, 2019
• Study Start: March 1, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 31, 2021
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)