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

NCT04875780 | Unknown

• 1 other identifier: HMRF03180248
• Study Type: interventional
• Target: 282
• 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, 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.

Conditions

Pre-diabetes

Keywords

Diabetes prevention; Pre-diabetes; Weight loss; Cardio-metabolic risk; Obesity; Lifestyle intervention; Smartphone-based

Outcome Measures

Primary Outcomes (1)

• Percent weight change

  % weight change from baseline

  % weight change at 4 and 12 months from baseline

Secondary Outcomes (14)

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

  Changes of insulin sensitivity at 12-months from baseline

• Fasting insulin

  Changes of fasting insulin to 12-months from baseline

• Fasting blood glucose (FG)

  Changes of FG at 12-months from baseline

• Haemoglobin A1C (HbA1C)

  Changes of HbA1c at 4 and 12-months from baseline

• Systolic and diastolic blood pressure (SBP, DBP)

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

Other Outcomes (1)

• Diabetes incidence

  At 12-months follow-up

Study Arms (3)

Digital diabetes prevention app intervention

EXPERIMENTAL

Participants will receive web-based diabetes prevention curriculum, virtual social group support and digital tracking via the smartphone app.

Behavioral: Digital diabetes prevention app intervention

Digital weight loss tracking app intervention

ACTIVE COMPARATOR

Participants will receive the same intervention as the digital diabetes prevention curriculum app group except the web-based diabetes prevention curriculum.

Behavioral: Digital weight loss tracking app intervention

Wait-list control (usual care)

OTHER

Participants will receive usual care in the form of an annual review and blood test, together with general lifestyle advice.

Behavioral: Wait-list control (usual care)

Interventions

Digital diabetes prevention app intervention BEHAVIORAL

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.

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

Digital diabetes prevention app intervention

Digital weight loss tracking app intervention BEHAVIORAL

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.

Also known as: Goal setting and self-monitoring, Virtual social support group

Digital weight loss tracking app intervention

Wait-list control (usual care) BEHAVIORAL

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.

Wait-list control (usual care)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

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 or long-term use of medicines 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

RECRUITING

Related Publications (18)

• 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

• 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

• 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.

  PMID: 33442078 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

• 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.

  PMID: 25218728 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

• 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

• 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

• 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.

  PMID: 27927218 BACKGROUND

• 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.

  PMID: 28948027 BACKGROUND

• 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.

  PMID: 26217509 BACKGROUND

• 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.

  PMID: 24139771 BACKGROUND

• Semper HM, Povey R, Clark-Carter D. A systematic review of the effectiveness of smartphone applications that encourage dietary self-regulatory strategies for weight loss in overweight and obese adults. Obes Rev. 2016 Sep;17(9):895-906. doi: 10.1111/obr.12428. Epub 2016 May 18.

  PMID: 27192162 BACKGROUND

• Michie S, Ashford S, Sniehotta FF, Dombrowski SU, Bishop A, French DP. A refined taxonomy of behaviour change techniques to help people change their physical activity and healthy eating behaviours: the CALO-RE taxonomy. Psychol Health. 2011 Nov;26(11):1479-98. doi: 10.1080/08870446.2010.540664. Epub 2011 Jun 28.

  PMID: 21678185 BACKGROUND

• World Health Organization. Definition and diagnosis of diabetes mellitus and intermediate hyperglycemia: report of a WHO/IDF consultation. Geneva: 2006.

  BACKGROUND

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

Central Study Contacts

Dr Mandy Ho

CONTACT

(+852)39176973; mandyho1@hku.hk

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 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.

Study Record Dates

• First Submitted: May 1, 2021
• First Posted: May 6, 2021
• Study Start: June 1, 2021
• Primary Completion: May 31, 2024
• 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)