Effectiveness of a Lifestyle Intervention Programme Using Mobile Application vs Booklet for Adult With Metabolic Syndrome

NCT03762434 | Completed DMC

• 1 other identifier: 1-BE0N
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Aims This Pilot study aims to develop and determine the feasibility and acceptability of a mobile application (MetS app) together with a modified Life style modification Program (LIP) for soon-to-aged adults with metabolic syndrome (MetS) and to determine the sample size for the main RCT. . Methods A prospective randomized control trial design with process evaluation will be adopted. Inclusion criteria are those MetS participants, age 45 or above, able to use a smart phone. A total of eighty eligible participants will be recruited from 2-3 community Centres. Control group will receive standard care while intervention group will receive a MetS app. Standard care consists of a modified three-month lifestyle modification booklet, a 30 minutes educational session. The intervention group will receive a 30 minute education session plus MetS support, which will be guided by health belief model to support an individual self- monitoring and record of health measures (body weight, blood pressure, waist circumference) and physical exercise (goal setting of exercise and record) across three months. All information from the LIP booklet are also installed in the MetS platform as well. The primary outcomes will be waist measure and the total physical exercise (GSLTPAQ). The secondary outcomes included cardio-metabolic risk factors, cardiovascular endurance, self-efficacy for exercise (SEE) and stress level (PSS-10) and quality of Life (SF12). Data will be collected at baseline, one-month (T1) and three-month (T2). SPSS version 23 and Generalized Estimating equations (GEE) model will be employed to examine the effects of the LIP with MetS app support.

Conditions

Metabolic Syndrome

Keywords

life style modification program; mobile application; metabolic sydrome; booklet; RCT

Outcome Measures

Primary Outcomes (2)

• Change in body weight

  body weight weighted at the same scale by the research assistant (RA) in the follow up

  1 month and 3 months

• Change in total physical exercise

  Total physical exercise quantified with a modified version of the GSLTPAQ \[31-32\]. The patients were instructed to indicate the amount of exercises and to rank the exercises in the order of difficulty (strenuous, moderate, and mild). Total physical exercise will be computed by summing up the total number of sessions per week multiplied by minutes per session. The scale has been widely used in empirical studies and it has been shown to have good psychometric properties with acceptable test-retest reliability (ranged from 0.62 to 0.81), and correlated with maximum oxygen consumption, treadmill time and other similar physical activity questionnaire. \[31-32\].

  baseline, 1 month and 3 months

Secondary Outcomes (10)

• Change in Chinese version of Self-Efficacy for Exercise (SEE-C)

  baseline, 1 month and 3 months

• change in Cardiovascular endurance test.

  baseline, 3 mobnths

• Change in Perceived stress scale (PSS-10)

  baseline, 1 month and 3 months

• Hospitalization frequency

  baseline, 3 months

• Mets app usage frequency

  monthly till 3 month

Study Arms (2)

mobile app

ACTIVE COMPARATOR

Mobile app: The participants will receive a Life style Modification Program with the support of mobile application (MetS app). The participants can view the similar knowledge content related to metabolic syndrome in their own smart phone. In addition, a membership area of the Mets app provides individual support of self- health monitoring, goal setting of exercise plan and exercise record. A user guide of the MetS app will be provided to the participants to take home after the app installment and briefing.

Other: mobile application

booklet

ACTIVE COMPARATOR

The participants will receive the Life Style Modification programme with the support of a Hong Kong version Metabolic Syndrome (MetS) booklet to take home and use for 3 months. The booklet had been modified from a booklet of a Life Style Intervention Programme (LIP) in China and the principal investigator of this proposal was the core team members of the previous project . The booklet content covers 26 pages about the metabolic syndrome and risk factors, suggested life style modification tips in terms of exercise, diet, smoking, mediation and stress management . The major component of the booklet for the change is the language translated from simplified Chinese to traditional Chinese and slight adjustment about the advice on vegetable choice due to difference in type of available vegetables in Hong Kong.

Other: mobile application

Interventions

mobile application OTHER

Mobile app: The participants can view the Life style modification program by using the app. In addition, a membership area of the app provides individual support of self- health monitoring, goal setting of exercise plan and exercise record. A user guide of the MetS app will be provided to the participants to take home after the briefing. Booklet : The booklet content covers 26 pages about the metabolic syndrome and risk factors, suggested life style modification tips in terms of exercise, diet, smoking, mediation and stress management.

Also known as: Booklet

booklet; mobile app

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Ethnic Chinese Client who has a smart phone.
• Adult age 45 or over
• MetS Clients \[1\] with central obesity (male \>90 cm , female \> 80cm ) plus two items of the followings :
• Raised triglycerides ≥ 150 mg/dL (1.7 mmol/L) or specific treatment for this lipid abnormality
• Reduced HDL cholesterol \< 40 mg/dL (1.03 mmol/L) in males \< 50 mg/dL (1.29 mmol/L) in females or treatment for this lipid abnormality
• Raised blood pressure systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg or treatment of previously diagnosed hypertension (HT)
• Raised fasting plasma glucose (FPG) ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes (DM)
• Clients with physical, mental, visual, or cognitive impairments with regular medical follow-ups and treatment, and those who have musculoskeletal disorders or other disabling diseases that may limit the practice of walking exercise will be excluded.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Sai Kung community centre

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Eliza ML Wong, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomisation and masking: A statistician will use computer-generated randomisation to determine random allocation. Eligible participants will be randomly allocated to either the control ( booklet group ) or the intervention group ( MetS app group) according to an allocation sequence prepared by the statistician before the start of the study. The patients will be randomised at a ratio of 1:1, with stratification by study site. Small cards indicating the group assignments will be placed in opaque sealed envelopes, which will be opened by the research assistant after each patient has completed the baseline questionnaires. In this study, the statisticians, outcome assessors and research assistant assigned to perform data input will be blinded to the allocation sequence. Given the type of intervention, however, the intervention group will be unmasked to the participants and the research nurse performing the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A multisite randomized controlled trial with two arms: MetS app group and , booklet group

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: December 3, 2018
• Study Start: November 26, 2018
• Primary Completion: March 31, 2019
• Study Completion: June 30, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

HK (1)