Clinical trial NCT03762434: Effectiveness of a Lifestyle Intervention Programme Using Mobile Application vs Booklet for Adult With Metabolic Syndrome
Official title: The Effectiveness of a Lifestyle Intervention Programme Using Mobile Application vs Booklet for Adult With Metabolic Syndrome _ a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: life style modification program
mobile application
metabolic sydrome
booklet
RCT
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 78
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multisite randomized controlled trial with two arms: MetS app group and , booklet group
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Background Educational programme intervention on Lifestyle modification is recommended as the primary intervention for metabolic syndrome (MetS), a cluster of cardio-metabolic risk factors with a high prevalence rate globally and locally. Recent studies of lifestyle intervention program (LIP) have been reported as effective on physical indicators and quality of life (QoL) among MetS adult. However, they have the challenges in the delivery in making care scalable and little is known about the effect on exercise outcomes such as total exercise, cardiovascular endurance after exercise as well as whether the outcomes of this programme can be applied in Hong Kong and improved by adding the mobile application.

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.

Significance This pilot study will provide insights to guide the main study. The findings will facilitate the development of MetS app that could support the self-efficacy for physical health monitoring and exercise of patients with MetS. Such programme may enhance patient's self-management and monitoring of MetS, exercise behavior sustainability that will be beneficial to reduced MetS risk profile, and improves psychological health and quality of life.

Eligibility criteria: Inclusion Criteria:

* Participants who satisfy the inclusion and exclusion criteria will be invited to participate in the RCT. The inclusion criteria are those :

  1. Ethnic Chinese Client who has a smart phone.
  2. Adult age 45 or over
  3. 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in body weight
timeFrame: 1 month and 3 months
measure: Change in total physical exercise
timeFrame: baseline, 1 month and 3 months
Secondary outcomes:
measure: Change in Chinese version of Self-Efficacy for Exercise (SEE-C)
timeFrame: baseline, 1 month and 3 months
measure: change in Cardiovascular endurance test.
timeFrame: baseline, 3 mobnths
measure: Change in Perceived stress scale (PSS-10)
timeFrame: baseline, 1 month and 3 months
measure: Hospitalization frequency
timeFrame: baseline, 3 months
measure: Mets app usage frequency
timeFrame: monthly till 3 month
measure: Booklet usage frequency
timeFrame: baseline, 1 month and 3 months
measure: Waist circumference (cm)
timeFrame: baseline, 1 month and 3 months
measure: Blood pressure (mmHg)
timeFrame: baseline, 1month and 3 months.
measure: Lipid level (mmol/L)
timeFrame: baseline and 3 months
measure: Fasting blood glucose level (mmol/L)
timeFrame: baseline, 1 month and 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Sai Kung community centre
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Eliza ML Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: