A Community-based Weight Loss Programme for Chinese Overweight Adults With Pre-diabetes

Pre-diabetes Clinical Trial

Official title:

Effects of a Community-based Weight Loss Programme Targetting Chinese Overweight Adults With Pre-diabetes: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03609697
• Other study ID #: HCPS01170498
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 10, 2018
• Est. completion date: May 31, 2024

Study information

• Verified date: October 2021
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Type 2 diabetes (T2DM) is a serious chronic condition and one of the world's fastest growing health problems. The onset of T2DM is gradual, with most individuals progressing through a state of pre-diabetes. Pre-diabetes is a prevalent and potentially reversible condition, which provides an important window of opportunity for the prevention of T2DM and its complications. This project aims to translate the evidence-based diabetes prevention strategies into a community setting to reduce diabetes risks in Hong Kong Chinese people with pre-diabetes .

Description:

Type 2 diabetes (T2DM) is a major non-communicable disease and one of the world's fastest growing health problem. It is associated with significant morbidity, including increased risk of heart disease and stroke, hypertension, retinopathy and blindness, renal failure and leg amputation, which place an enormous burden on individuals, society and the healthcare system. The T2DM trend in Hong Kong mirrors the global trend. It is a major cause of mortality and morbidity with approximately 700,000 people diagnosed with diabetes, representing 10% of Hong Kong's total population.

T2DM is a non-reversible, yet a preventable condition. The onset of T2DM is gradual, with most individuals progressing through a state of pre-diabetes. People with pre-diabetes, defined as having impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or elevated glycated haemoglobulin (HbA1C) , are at increased risk of developing T2DM and its associated complications, such as heart diseases and retinopathy, which can develop even in the absence of progression to overt T2DM. Hence, it is essential that people with pre-diabetes are targeted for early intervention to prevent T2DM and related complications.

International clinical trials demonstrated that lifestyle interventions targeting at least 5% weight loss in individuals with pre-diabetes can be cost-effective in preventing T2DM. Lifestyle intervention (which includes diet, physical activity and behavioural modification components) and self-management of pre-diabetes has been listed as an effective means of decreasing the incidence of T2DM in the international guidelines on management of pre-diabetes.

The aim of this study is to translate preventive research into effective community-based intervention by setting up a culturally appropriate lifestyle intervention programme for the prevention of T2DM in Hong Kong Chinese adults with pre-diabetes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• aged 30 to 65 years

• overweight (BMI = 23kg/m2) or obese (BMI = 25 kg/m2)

• with at least one blood test result showing IGT (7.8-11.0 mmol/L after a two-hour glucose tolerance test), IFG (fasting glucose 5.6 - 6.9 mmol/L) or impaired HbA1c 5.7%
• 6.4%

• have a mobile phone

• able to read Chinese and speak Cantonese.

Exclusion Criteria:

• with current or clinical history of T2DM, or with co-morbid conditions that may limit participation in the study, such as recent history of an acute cardiovascular event, uncontrolled hypertension, cancer or major psychiatric or cognitive problems

• already participating in a weight loss programme

• receiving drug treatment for pre-diabetes (e.g. Metformin) or long-term use of medications known to influence glucose metabolism (e.g. corticosteroids)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Overweight
• Pre-diabetes
• Prediabetic State
• Weight Loss

Intervention

Behavioral:
• group-based lifestyle intervention
Involve education about pre-diabetes self-management, weight loss, behavioural modification skills, nutrition and physical activity.
• Minimal intervention (SMS intervention)
Text message related to general information about T2DM, pre-diabetes, and lifestyle modification.

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (15)

American Diabetes Association. (2) Classification and diagnosis of diabetes. Diabetes Care. 2015 Jan;38 Suppl:S8-S16. doi: 10.2337/dc15-S005. Review. — View Citation

Gong Q, Gregg EW, Wang J, An Y, Zhang P, Yang W, Li H, Li H, Jiang Y, Shuai Y, Zhang B, Zhang J, Gerzoff RB, Roglic G, Hu Y, Li G, Bennett PH. Long-term effects of a randomised trial of a 6-year lifestyle intervention in impaired glucose tolerance on diabetes-related microvascular complications: the China Da Qing Diabetes Prevention Outcome Study. Diabetologia. 2011 Feb;54(2):300-7. doi: 10.1007/s00125-010-1948-9. Epub 2010 Nov 3. — View Citation

Guariguata L, Whiting DR, Hambleton I, Beagley J, Linnenkamp U, Shaw JE. Global estimates of diabetes prevalence for 2013 and projections for 2035. Diabetes Res Clin Pract. 2014 Feb;103(2):137-49. doi: 10.1016/j.diabres.2013.11.002. Epub 2013 Dec 1. — View Citation

Hospital Authority of Hong Kong. Hospital Authority Statistical Report 2009-2010 [Internet]. Hong Kong; 2011 [cited 2015 Jan 26 ]. 182 p. Available from: http://www.ha.org.hk/ho/corpcomm/Statistical%20Report/2009-10.pdf

Katula JA, Vitolins MZ, Rosenberger EL, Blackwell CS, Morgan TM, Lawlor MS, Goff DC Jr. One-year results of a community-based translation of the Diabetes Prevention Program: Healthy-Living Partnerships to Prevent Diabetes (HELP PD) Project. Diabetes Care. 2011 Jul;34(7):1451-7. doi: 10.2337/dc10-2115. Epub 2011 May 18. Erratum in: Diabetes Care. 2012 Feb;35(2):455. — View Citation

Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. — View Citation

Levitan EB, Song Y, Ford ES, Liu S. Is nondiabetic hyperglycemia a risk factor for cardiovascular disease? A meta-analysis of prospective studies. Arch Intern Med. 2004 Oct 25;164(19):2147-55. — View Citation

Lindström J, Peltonen M, Eriksson JG, Ilanne-Parikka P, Aunola S, Keinänen-Kiukaanniemi S, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study (DPS). Improved lifestyle and decreased diabetes risk over 13 years: long-term follow-up of the randomised Finnish Diabetes Prevention Study (DPS). Diabetologia. 2013 Feb;56(2):284-93. doi: 10.1007/s00125-012-2752-5. Epub 2012 Oct 24. — View Citation

Nathan DM, Davidson MB, DeFronzo RA, Heine RJ, Henry RR, Pratley R, Zinman B; American Diabetes Association. Impaired fasting glucose and impaired glucose tolerance: implications for care. Diabetes Care. 2007 Mar;30(3):753-9. Review. — View Citation

Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao HB, Liu PA, Jiang XG, Jiang YY, Wang JP, Zheng H, Zhang H, Bennett PH, Howard BV. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care. 1997 Apr;20(4):537-44. — View Citation

Payne WR, Walsh KJ, Harvey JT, Livy MF, McKenzie KJ, Donaldson A, Atkinson MG, Keogh JB, Moss RS, Dunstan DW, Hubbard WA. Effect of a low-resource-intensive lifestyle modification program incorporating gymnasium-based and home-based resistance training on type 2 diabetes risk in Australian adults. Diabetes Care. 2008 Dec;31(12):2244-50. doi: 10.2337/dc08-0152. Epub 2008 Sep 16. — View Citation

Ramachandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V; Indian Diabetes Prevention Programme (IDPP). The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Diabetologia. 2006 Feb;49(2):289-97. Epub 2006 Jan 4. — View Citation

Singleton JR, Smith AG, Russell JW, Feldman EL. Microvascular complications of impaired glucose tolerance. Diabetes. 2003 Dec;52(12):2867-73. Review. — View Citation

Twigg SM, Kamp MC, Davis TM, Neylon EK, Flack JR; Australian Diabetes Society; Australian Diabetes Educators Association. Prediabetes: a position statement from the Australian Diabetes Society and Australian Diabetes Educators Association. Med J Aust. 2007 May 7;186(9):461-5. — View Citation

Yoon KH, Lee JH, Kim JW, Cho JH, Choi YH, Ko SH, Zimmet P, Son HY. Epidemic obesity and type 2 diabetes in Asia. Lancet. 2006 Nov 11;368(9548):1681-8. Review. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent weight change	% weight change from baseline	% weight change from baseline at 6-month and 12-months
Secondary	Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	Estimated from fasting insulin and fasting glucose, [fasting insulin (uU/mL)*fasting glucose(mmol/L)]/22.5	Changes from baseline insulin sensitivity at 6-month and 12-months
Secondary	Fasting insulin	Fasting insulin	Changes from baseline fasting insulin at 6-month and 12-months
Secondary	Fasting blood glucose (FG)	Fasting blood glucose	Changes from baseline FG at 6-month and 12-months
Secondary	Haemoglobin A1C (HbA1C)	HbA1C	Changes from baseline HbA1Cat 6-month and 12-months
Secondary	Systolic and diastolic blood pressure (SBP, DBP)	measured by automatic BP monitor	Changes from baseline SBP and DBP at 6-month and 12-months
Secondary	Blood lipid profile	fasting blood for total cholesterol, HDL, LDL and triglycerides	Changes from baseline blood lipid to 6-month and 12-months
Secondary	Diabetes status	Oral glucose tolerance test	6-month and 12-months follow-up
Secondary	Physical activity	International physical activity questionnaire short form (IPAQ, Chinese version). A validated 6-item questionnaire to assess the frequency and duration of vigorous intensity activity, moderate intensity activity, and walking. The questionnaire will be scored using established methods (www.ipaq.ki.se). Data will be summarized to report physical activity in categories: High-active group; Vigorous-intensity activity on = 3 days and accumulating =1500 MET-minutes/week OR; =7 days of any combination of walking, moderate-intensity or vigorous intensity activities achieving =3000 MET-minutes/week; Moderate-active group; =3 days of vigorous activity of =20 minutes/day OR; =5 days of moderate-intensity activity or walking of =30 minutes/day OR; =5 days of any combination of walking, moderate-intensity or vigorous intensity activities achieving =600 MET-min/week.; Low-active/inactive group Individuals who do not meet criteria for high- and moderate-active	Change in levels of physical activity from baseline to 6-month and 12-months
Secondary	Dietary intake	24 hour recalls	Changes in dietary intake from baseline to 6-month and 12-months
Secondary	Health-related quality of life (HRQOL)	12-item Short Form Survey (SF12 Chinese version). It is a validated scale which provides two summary measures. Physical and Mental Health Composite Scores (PCS & MCS) will be computed using the scores of 12 questions and range from 0 to 100. Higher scores represent better health.	Changes in HRQOL from baseline to 6-month and 12-months
Secondary	Carotid artery intima-media thickness (cIMT)	High-resolution B-mode ultrasonography	Change in cIMT from baseline to 6-month and 12-months