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Pre-diabetesNCT04875780

A Smartphone-based Intervention for Diabetes Prevention in Overweight Chinese Adults With Pre-diabetes

A study testing Digital diabetes prevention app intervention and Digital weight loss tracking app 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 The sponsor has not verified this record for over two years, so it may be out of date.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, which provides an important window of opportunity for the prevention of T2DM and its complications. Read more about this study

Who is it for?
Ages 40 to 60 years
Conditions the study is for
Pre-diabetes
What is being tested?
Digital diabetes prevention app intervention and Digital weight loss tracking app intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
282 participants
Where
1 siteHong Kong
Study dates
1 Jun 2021to 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 40 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Individuals aged 40 - 60 years old
  • 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%
  • Owns a smartphone
  • 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 or long-term use of medicines known to influence glucose metabolism (e.g. corticosteroids)

Trial locations and contacts

1 site in 1 country.

Dr Mandy Ho contact

(+852)39176973

mandyho1@hku.hk

Hong Kong1 site, 1 recruiting

  • The University of Hong Kong

    Hong Kong

    Mandy Ho, PhD, (+852) 39176973, mandyho1@hku.hk

    Mandy Ho, PhD

    Recruiting

Other trials in Hong Kong

About this study

Official title: Effects of a Smartphone-based Weight Loss Programme Targeting 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, 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 community setting and utilize mobile health technology to reduce diabetes risks in Hong Kong.

Read the detailed description

Type 2 diabetes (T2DM) is a major global health issue and the cost to community is high and escalating. The Asia-Pacific region carries a high disease burden, with more than 60% of the global diabetic population living in Asian region. The onset of T2DM is gradual, with most individuals progressing through a state of pre-diabetes. A National Survey conducted in China in 2010 revealed that 50.1% of people aged 18 or older have 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.

Obesity is a major risk factor for developing T2DM. International trials demonstrate that lifestyle interventions (which includes diet, physical activity and behavioural modification components) targeting at least 5% weight loss in individuals with pre-diabetes can reduce 3-year diabetes incidence by 58%. Growing evidence suggests that smartphones may be a promising platform for delivery of behavioural lifestyle intervention to achieve weight loss.

This project aims to translate the evidence-based diabetes prevention strategies into community setting and utilize mobile health technology to reduce diabetes risks in Hong Kong.

Conditions
Pre-diabetes
Being tested
Digital diabetes prevention app intervention, Digital weight loss tracking app intervention, Wait-list control (usual care)
Keywords
Diabetes prevention, Pre-diabetes, Weight loss, Cardio-metabolic risk, Obesity, Lifestyle intervention, Smartphone-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.

  • Digital diabetes prevention app interventionBehavioural

    Also called Web-based diabetes prevention curriculum, Goal setting and self-monitoring, Virtual social support group

    16-week core program consisting of 16 online weekly interactive lessons on diet and physical activity for weight loss. After the completion of the core program, participant can proceed to the 36-week post-core phase. The post-core program provides 8 monthly lessons focusing on maintaining lifestyle habits and weight loss.

    Participants will be guided to use the smartphone app for goal setting and self-monitoring of diet, physical activity and weight loss.

    Participants will be demographically matched into online groups of 10-12 persons. Online group discussion board will be set up for participants to discuss goals, share progress and provide supports to each other.

  • Digital weight loss tracking app interventionBehavioural

    Also called Goal setting and self-monitoring, Virtual social support group

    All participants will be provided the same smartphone app as the intervention group for goal setting and self-monitoring of diet, physical activity and weight loss.

    Participants will be demographically matched into online groups of 10-12 person. Online group discussion board will be set up for participants to discuss goals, share progress and provide supports to each other.

  • Wait-list control (usual care)Behavioural

    Participants in the control group will be invited to have an annual review and blood test at baseline, 4 and 12 months and received general lifestyle advices from a registered nurse at a community clinic.

Study groups in NCT04875780
Study groupRoleWhat they receive
Digital diabetes prevention app interventionExperimentalParticipants will receive web-based diabetes prevention curriculum, virtual social group support and digital tracking via the smartphone app.
Receives: Behavioral: Digital diabetes prevention app intervention
Digital weight loss tracking app interventionActive comparatorParticipants will receive the same intervention as the digital diabetes prevention curriculum app group except the web-based diabetes prevention curriculum.
Receives: Behavioral: Digital weight loss tracking app intervention
Wait-list control (usual care)OtherParticipants will receive usual care in the form of an annual review and blood test, together with general lifestyle advice.
Receives: Behavioral: Wait-list control (usual care)

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 at 4 and 12 months from baseline

Secondary outcomes (14)

  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 of insulin sensitivity at 12-months from baseline

  2. Fasting insulin

    Fasting insulin in mU/L

    Measured: Changes of fasting insulin to 12-months from baseline

  3. Fasting blood glucose (FG)

    Fasting blood glucose in mmol/L > 8 hours of fasting

    Measured: Changes of FG at 12-months from baseline

  4. Haemoglobin A1C (HbA1C)

    HbA1c in %

    Measured: Changes of HbA1c at 4 and 12-months from baseline

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

    in mmHg measured by automatic BP monitor

    Measured: Changes of SBP and DBP to 4 and 12-months from baseline

  6. Blood lipid profile

    fasting blood for total cholesterol, HDL, LDL and triglycerides, all in mmol/L

    Measured: Changesof blood lipid at 12-months from baseline

  7. 2hr post OGTT glucose (2hr PP)

    Blood glucose in mmol/L 2 hours after OGTT

    Measured: Changes of 2hr PP at 12-months from baseline

  8. Physical activity as assessed by IPAQ

    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 4 and 12-months

  9. Dietary intake as assessed by 24-hour recall

    24-hour food recall

    Measured: Changes in dietary intake from baseline to 4 and 12-months

  10. Health-related quality of life (HRQOL) as assessed by SF12

    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 4 and 12-months

  11. Central obesity

    Waist circumference in cm

    Measured: Changes of waist circumference at 12-months from baseline

  12. Percentage body fat as assessed by BIA

    Bioelectrical impedance analysis measuring body fat in %

    Measured: Changes of body fat at 12-months from baseline

  13. Smartphone apps user engagement

    User's overall login frequency and duration to the app and login frequency and duration to each module, as well as the frequency of participation in the group sharing and discussion. Usage data will be obtained from the apps administrative portal.

    Measured: At 12-months follow-up

  14. User feedback as assessed by an online exit questionnaire

    An online exit questionnaire will be administered to participants in the intervention group at 12 months.

    Measured: At 12-months follow-up

Timeline

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

  1. First posted6 May 2021
  2. Study start1 Jun 2021
  3. Primary completion31 May 2024 (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 3-arm randomised controlled trial, RCT (the digital diabetes prevention app group, the digital weight loss tracking app group, and the wait-list usual care group). The digital diabetes prevention app group will receive these intervention components: web-based diabetes prevention curriculum, virtual social group support, goal setting and self-monitoring via the smartphone app. The digital weight loss tracking group will receive digital tracking of weight loss, diet and physical activity and virtual social support group function (mimicking the publically available weight loss apps), but without the web-based diabetes prevention curriculum. The wait-list usual care group will receive usual care in the form of an annual review and blood test, together with general lifestyle advice at our NGO collaborator's (UCN) community clinics.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
282 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04875780
Sponsor's protocol ID
HMRF03180248
Status last verified
Oct 2021
First submitted
1 May 2021
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

  • 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

  • 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

  • Mirasol R, Thai AC, Salahuddin AA, Tan K, Deerochanawong C, Mohamed M, Saraswati MR, Sethi BK, Shah S, Soetedjo NN, Suraamornkul S, Tan R, Uddin F. A Consensus of Key Opinion Leaders on the Management of Pre-diabetes in the Asia-Pacific Region. J ASEAN Fed Endocr Soc. 2017;32(1):6-12. doi: 10.15605/jafes.032.01.02. Epub 2017 May 5.

    PubMed 33442078

  • 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

  • Chan JC, Zhang Y, Ning G. Diabetes in China: a societal solution for a personal challenge. Lancet Diabetes Endocrinol. 2014 Dec;2(12):969-79. doi: 10.1016/S2213-8587(14)70144-5. Epub 2014 Sep 10.

    PubMed 25218728

  • 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

  • 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

  • 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

  • Schoeppe S, Alley S, Van Lippevelde W, Bray NA, Williams SL, Duncan MJ, Vandelanotte C. Efficacy of interventions that use apps to improve diet, physical activity and sedentary behaviour: a systematic review. Int J Behav Nutr Phys Act. 2016 Dec 7;13(1):127. doi: 10.1186/s12966-016-0454-y.

    PubMed 27927218

  • Sepah SC, Jiang L, Ellis RJ, McDermott K, Peters AL. Engagement and outcomes in a digital Diabetes Prevention Program: 3-year update. BMJ Open Diabetes Res Care. 2017 Sep 7;5(1):e000422. doi: 10.1136/bmjdrc-2017-000422. eCollection 2017.

    PubMed 28948027

  • Khokhar B, Jones J, Ronksley PE, Armstrong MJ, Caird J, Rabi D. Effectiveness of mobile electronic devices in weight loss among overweight and obese populations: a systematic review and meta-analysis. BMC Obes. 2014 Oct 14;1:22. doi: 10.1186/s40608-014-0022-4. eCollection 2014.

    PubMed 26217509

  • Azar KM, Lesser LI, Laing BY, Stephens J, Aurora MS, Burke LE, Palaniappan LP. Mobile applications for weight management: theory-based content analysis. Am J Prev Med. 2013 Nov;45(5):583-9. doi: 10.1016/j.amepre.2013.07.005.

    PubMed 24139771

Questions about this trial

What is this clinical trial studying?

A study testing Digital diabetes prevention app intervention and Digital weight loss tracking app 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?

Contact Dr Mandy Ho ((+852)39176973, mandyho1@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent weight change (time frame: % weight change at 4 and 12 months from baseline). 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 NCT04875780, which also lists 18 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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