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

Pre-diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04875780
• Other study ID #: HMRF03180248
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: October 2021
• Source: The University of Hong Kong
• Contact: Dr Mandy Ho
• Phone: (+852)39176973
• Email: mandyho1[@]hku.hk
• 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, 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 282
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

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 or long-term use of medicines known to influence glucose metabolism (e.g. corticosteroids)

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Digital diabetes prevention app intervention
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 intervention
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)
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.

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 (18)

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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

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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. — 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

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. — View Citation

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. — 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

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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

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 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diabetes incidence	Oral glucose tolerance test (OGTT) in mmol/L measured 2 hours after 75g oral glucose intake post overnight fast. Diabetes is defined as FG=7.0mmol/L or 2hr post OGTT = 11.1mmol/L	At 12-months follow-up
Primary	Percent weight change	% weight change from baseline	% weight change at 4 and 12 months from baseline
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 of insulin sensitivity at 12-months from baseline
Secondary	Fasting insulin	Fasting insulin in mU/L	Changes of fasting insulin to 12-months from baseline
Secondary	Fasting blood glucose (FG)	Fasting blood glucose in mmol/L > 8 hours of fasting	Changes of FG at 12-months from baseline
Secondary	Haemoglobin A1C (HbA1C)	HbA1c in %	Changes of HbA1c at 4 and 12-months from baseline
Secondary	Systolic and diastolic blood pressure (SBP, DBP)	in mmHg measured by automatic BP monitor	Changes of SBP and DBP to 4 and 12-months from baseline
Secondary	Blood lipid profile	fasting blood for total cholesterol, HDL, LDL and triglycerides, all in mmol/L	Changesof blood lipid at 12-months from baseline
Secondary	2hr post OGTT glucose (2hr PP)	Blood glucose in mmol/L 2 hours after OGTT	Changes of 2hr PP at 12-months from baseline
Secondary	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: 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 4 and 12-months
Secondary	Dietary intake as assessed by 24-hour recall	24-hour food recall	Changes in dietary intake from baseline to 4 and 12-months
Secondary	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.	Changes in HRQOL from baseline to 4 and 12-months
Secondary	Central obesity	Waist circumference in cm	Changes of waist circumference at 12-months from baseline
Secondary	Percentage body fat as assessed by BIA	Bioelectrical impedance analysis measuring body fat in %	Changes of body fat at 12-months from baseline
Secondary	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.	At 12-months follow-up
Secondary	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.	At 12-months follow-up