Clinical trial NCT04875780: A Smartphone-based Intervention for Diabetes Prevention in Overweight Chinese Adults With Pre-diabetes
Official title: Effects of a Smartphone-based Weight Loss Programme Targeting Chinese Overweight Adults With Pre-diabetes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pre-diabetes
Keywords: Diabetes prevention
Pre-diabetes
Weight loss
Cardio-metabolic risk
Obesity
Lifestyle intervention
Smartphone-based
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 282
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percent weight change
timeFrame: % weight change at 4 and 12 months from baseline
Secondary outcomes:
measure: Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: Changes of insulin sensitivity at 12-months from baseline
measure: Fasting insulin
timeFrame: Changes of fasting insulin to 12-months from baseline
measure: Fasting blood glucose (FG)
timeFrame: Changes of FG at 12-months from baseline
measure: Haemoglobin A1C (HbA1C)
timeFrame: Changes of HbA1c at 4 and 12-months from baseline
measure: Systolic and diastolic blood pressure (SBP, DBP)
timeFrame: Changes of SBP and DBP to 4 and 12-months from baseline
measure: Blood lipid profile
timeFrame: Changesof blood lipid at 12-months from baseline
measure: 2hr post OGTT glucose (2hr PP)
timeFrame: Changes of 2hr PP at 12-months from baseline
measure: Physical activity as assessed by IPAQ
timeFrame: Change in levels of physical activity from baseline to 4 and 12-months
measure: Dietary intake as assessed by 24-hour recall
timeFrame: Changes in dietary intake from baseline to 4 and 12-months
measure: Health-related quality of life (HRQOL) as assessed by SF12
timeFrame: Changes in HRQOL from baseline to 4 and 12-months
measure: Central obesity
timeFrame: Changes of waist circumference at 12-months from baseline
measure: Percentage body fat as assessed by BIA
timeFrame: Changes of body fat at 12-months from baseline
measure: Smartphone apps user engagement
timeFrame: At 12-months follow-up
measure: User feedback as assessed by an online exit questionnaire
timeFrame: At 12-months follow-up
Other outcomes:
measure: Diabetes incidence
timeFrame: At 12-months follow-up
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong, HONG KONG
name: Dr Mandy Ho
role: PRINCIPAL_INVESTIGATOR
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