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

NCT03609697 | Unknown

• 1 other identifier: HCPS01170498
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Pre-diabetes

Keywords

Diabetes prevention; Pre-diabetes; Weight loss; Cardio-metabolic risks; Obesity; Lifestyle intervention; Community-based

Outcome Measures

Primary Outcomes (1)

• Percent weight change

  % weight change from baseline

  % weight change from baseline at 6-month and 12-months

Secondary Outcomes (11)

• Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

  Changes from baseline insulin sensitivity at 6-month and 12-months

• Fasting insulin

  Changes from baseline fasting insulin at 6-month and 12-months

• Fasting blood glucose (FG)

  Changes from baseline FG at 6-month and 12-months

• Haemoglobin A1C (HbA1C)

  Changes from baseline HbA1Cat 6-month and 12-months

• Systolic and diastolic blood pressure (SBP, DBP)

  Changes from baseline SBP and DBP at 6-month and 12-months

Study Arms (2)

Community-based lifestyle intervention

EXPERIMENTAL

Participants will attend 7 community-based group intervention sessions plus 2 individual face-to-face dietician consultation sessions during the first 6 months, followed by a 6-month maintenance phase which they will receive monthly phone support from the research team.

Behavioral: group-based lifestyle intervention

Minimal intervention (SMS intervention)

OTHER

Participants will receive one SMS per month during the first 6 months, followed by a 6-month maintenance phase which participants will receive one SMS every 2 months.

Behavioral: Minimal intervention (SMS intervention)

Interventions

group-based lifestyle intervention BEHAVIORAL

Involve education about pre-diabetes self-management, weight loss, behavioural modification skills, nutrition and physical activity.

Also known as: individual dietitian consultation, Telephone support, community-based intervention

Community-based lifestyle intervention

Minimal intervention (SMS intervention) BEHAVIORAL

Text message related to general information about T2DM, pre-diabetes, and lifestyle modification.

Minimal intervention (SMS intervention)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (16)

• 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.

  PMID: 24630390 BACKGROUND

• American Diabetes Association. (2) Classification and diagnosis of diabetes. Diabetes Care. 2015 Jan;38 Suppl:S8-S16. doi: 10.2337/dc15-S005. No abstract available.

  PMID: 25537714 BACKGROUND

• 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. doi: 10.1016/S0140-6736(06)69703-1.

  PMID: 17098087 BACKGROUND

• 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

  BACKGROUND

• 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. doi: 10.1001/archinte.164.19.2147.

  PMID: 15505129 BACKGROUND

• 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. doi: 10.2337/dc07-9920. No abstract available.

  PMID: 17327355 BACKGROUND

• Singleton JR, Smith AG, Russell JW, Feldman EL. Microvascular complications of impaired glucose tolerance. Diabetes. 2003 Dec;52(12):2867-73. doi: 10.2337/diabetes.52.12.2867.

  PMID: 14633845 BACKGROUND

• 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. doi: 10.2337/diacare.20.4.537.

  PMID: 9096977 BACKGROUND

• 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. doi: 10.1007/s00125-005-0097-z. Epub 2006 Jan 4.

  PMID: 16391903 BACKGROUND

• 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. doi: 10.1056/NEJMoa012512.

  PMID: 11832527 BACKGROUND

• 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.

  PMID: 21046360 BACKGROUND

• Lindstrom J, Peltonen M, Eriksson JG, Ilanne-Parikka P, Aunola S, Keinanen-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.

  PMID: 23093136 BACKGROUND

• 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. doi: 10.5694/j.1326-5377.2007.tb00998.x.

  PMID: 17484708 BACKGROUND

• 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.

  PMID: 18796621 BACKGROUND

• 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.

  PMID: 21593290 BACKGROUND

• Ho M, Chau PH, Yu EYT, Ying MT, Lam CLK. Community-based weight loss programme targeting overweight Chinese adults with pre-diabetes: study protocol of a randomised controlled trial. BMJ Open. 2020 Apr 8;10(4):e035196. doi: 10.1136/bmjopen-2019-035196.

  PMID: 32273317 DERIVED

MeSH Terms

Conditions

Glucose Intolerance; Weight Loss; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Dr Mandy Ho

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All outcome assessors will be blinded to group allocation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: It is a 12-month 2-arm randomised controlled trial, RCT (the lifestyle intervention group and the SMS intervention group) with a 3 year follow up. The programme will proceed in two phases: the intensive intervention phase (0-6 months) and the maintenance phase (7-12 months). During the intensive intervention phase, participants in the lifestyle intervention group will attend 7 group-based interventions plus two sessions of individual face-to-face dietician consultation. During the maintenance phase, participants will receive monthly phone call from the research team. The SMS intervention group will receive regular SMS during both the intensive intervention and the maintenance phases.

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: August 1, 2018
• Study Start: August 10, 2018
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2024
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)