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Pre-diabetesNCT03609697

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

A study testing group-based lifestyle intervention and Minimal intervention (SMS intervention) in people with Pre-diabetes, run by The University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
Pre-diabetes
What is being tested?
group-based lifestyle intervention and Minimal intervention (SMS intervention)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteHong Kong
Study dates
10 Aug 2018to 31 May 2024
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 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

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

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 .

Read the detailed 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.

Conditions
Pre-diabetes
Being tested
group-based lifestyle intervention, Minimal intervention (SMS intervention)
Keywords
Diabetes prevention, Pre-diabetes, Weight loss, Cardio-metabolic risks, Obesity, Lifestyle intervention, Community-based
Medical subject headings
Glucose Intolerance, Weight Loss, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • group-based lifestyle interventionBehavioural

    Also called individual dietitian consultation, Telephone support, community-based intervention

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

  • Minimal intervention (SMS intervention)Behavioural

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

Study groups in NCT03609697
Study groupRoleWhat they receive
Community-based lifestyle interventionExperimentalParticipants 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.
Receives: Behavioral: group-based lifestyle intervention
Minimal intervention (SMS intervention)OtherParticipants 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.
Receives: Behavioral: Minimal intervention (SMS intervention)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent weight change

    % weight change from baseline

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

Secondary outcomes (11)

  1. 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

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

  2. Fasting insulin

    Fasting insulin

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

  3. Fasting blood glucose (FG)

    Fasting blood glucose

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

  4. Haemoglobin A1C (HbA1C)

    HbA1C

    Measured: Changes from baseline HbA1Cat 6-month and 12-months

  5. Systolic and diastolic blood pressure (SBP, DBP)

    measured by automatic BP monitor

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

  6. Blood lipid profile

    fasting blood for total cholesterol, HDL, LDL and triglycerides

    Measured: Changes from baseline blood lipid to 6-month and 12-months

  7. Diabetes status

    Oral glucose tolerance test

    Measured: 6-month and 12-months follow-up

  8. 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:

    1. 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
    1. 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.
    1. Low-active/inactive group Individuals who do not meet criteria for high- and moderate-active

    Measured: Change in levels of physical activity from baseline to 6-month and 12-months

  9. Dietary intake

    24 hour recalls

    Measured: Changes in dietary intake from baseline to 6-month and 12-months

  10. 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.

    Measured: Changes in HRQOL from baseline to 6-month and 12-months

  11. Carotid artery intima-media thickness (cIMT)

    High-resolution B-mode ultrasonography

    Measured: Change in cIMT from baseline to 6-month and 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2018
  2. Study start10 Aug 2018
  3. Primary completion31 May 2022 (estimated)
  4. Study completion31 May 2024 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03609697
Sponsor's protocol ID
HCPS01170498
Status last verified
Oct 2021
First submitted
13 Jul 2018
Last updated
25 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make individual participant data available to other researchers.

Publications

  • 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.

    PubMed 24630390

  • 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.

    PubMed 25537714

  • 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.

    PubMed 17098087

  • 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

  • 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.

    PubMed 15505129

  • 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.

    PubMed 17327355

  • 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.

    PubMed 14633845

  • 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.

    PubMed 9096977

  • 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.

    PubMed 16391903

  • 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.

    PubMed 11832527

  • 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.

    PubMed 21046360

  • 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.

    PubMed 23093136

  • 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.

    PubMed 17484708

  • 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.

    PubMed 18796621

  • 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.

    PubMed 21593290

Questions about this trial

What is this clinical trial studying?

A study testing group-based lifestyle intervention and Minimal intervention (SMS intervention) in people with Pre-diabetes, run by The 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Oct 2021. 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. 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?

Results are not available in the source record.

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?

Percent weight change (time frame: % weight change from baseline at 6-month and 12-months). 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 NCT03609697, which also lists 16 linked publications.

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 25 Oct 2021.

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