Clinical trial NCT05894252: Walking Interventions to Improve Quality of Life Among Adults with T2D in SA and the UK
Official title: Walking Interventions to Improve Quality of Life Among Adults with Type 2 Diabetes in Saudi Arabia and the United Kingdom: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Quality of Life
Keywords: Type 2 Diabetes
Intervention
Quality of life
Wellbeing
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are 2 groups (i) walking intervention (ii) control group.
Primary purpose: BASIC_SCIENCE

Brief summary: The research will be conducted as a quantitative experimental study (as an intervention). For the primary DV, quality of life, there are two effective measures.

* Health-related Quality of Life (HRQoL) scales of the SF-36 short form
* Euro-QoL instruments (EQ-5D).

Additionally, secondary variables assessed will be:

* (Physical Activity (the International PA questionnaire, short form - IPAQ)
* General Anxiety (the Generalised Anxiety Disorder Assessment - GAD-7
* Symptoms of Depression (the Patient Health Questionnaire - PHQ-9)
* Habitual diet will be assessed with the EPIC food frequency questionnaire,
* Memory function through the Gorilla online questionnaire (Memory Intrusion - TB1 and TB2).
* Health locus of control (Multidimensional Health Locus of Control form C)

Participants in the intervention group will be required to complete a 30-minute walk five days a week for 12 weeks. This will be in addition to any regular walking or exercise they are currently doing, which will be assessed via questionnaire at baseline. In the control group, participants will be asked to continue with their daily routines and usual level of physical activity.

The baseline measurements will be taken before the intervention at week zero. Subsequently, all the participants will attend a virtual meeting (screening visit) to learn about the key aspects of the research, including the required actions of the control and intervention groups, how to use the act watch and report the required data. All participants in the intervention group and the control group will be required to wear acti-watches, which will be given to them for free.

Participants in both groups will be asked to report the number of steps covered each week. Participants will report this information through an online link provided by the researcher. Each participant will access their data through an app that comes with the watch, however, the researchers will not have access to the app

Detailed description: Diabetes mellitus is a common disease worldwide that affects individuals through physical complications and associated mental health challenges. Physical inactivity among adults with type 2 diabetes is a major public health concern, as it negatively impacts patients' quality of life, especially when they are unable to manage their condition appropriately.

Type 2 diabetes (T2D)-among the leading causes of death and poor quality of life (QoL) in the UK and Saudi Arabia-has two major risk factors: diet and physical activity. The current study will evaluate the efficacy of a walking intervention to improve quality of life of adults with type 2 diabetes in Saudi Arabia and the United Kingdom. A secondary objective is to determine whether the efficacy of the walking intervention differs between populations with type 2 diabetes in the UK and Saudi Arabia.

Participants in the intervention group will be required to complete a 30-minute walk five days a week for 12 weeks. All participants in this study will be required to wear smartwatches or fitness trackers, which will be given to them for free. There will be no direct access to participants' device data for this study; rather, participants will report the data via an online link. Participants, both in the intervention group and in the control group, will be informed of what the study seeks to achieve. In this case, it examines the role of physical activity in health outcomes and quality of life among individuals diagnosed with type 2 diabetes. The experimental group will be given specific instructions to follow for 12 weeks about physical activity. In contrast, the control group will be asked to continue their physical activity as normal for 12 weeks.

The participants will need to have an online screening meeting with the researcher. This will allow the investigator to check whether the participants meet the inclusion criteria. At the screening, participants will complete an online survey that will take approximately 10-15 minutes. The questions will be related to various experiences, physical activity, habitual diet, and feelings associated with diabetes. At the end of the screening session, if participants agree to take part in this study, they will be asked to electronically sign a consent form. Once the screening session is completed, participants will be randomly assigned to one of two groups: the experimental group or the control group.

Assessment will be done via a 30 minute online session at the beginning and end of the 12 week period to measure the following variables: height and weight, blood glucose, physical activity level, anxiety, depression, quality of life, and memory function. A fitness tracker acti-watch will be used to track the physical activity of participants. This will be provided to participants free of charge. Participants will be asked to report their total number of steps each week via an online link provided by the researcher on a weekly basis.

Two versions of all research materials will be created (English and Arabic). To ensure reliability, all the Arabic versions of the questionnaires have been independently validated and published elsewhere.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes.
* Residing in the UK or Saudi Arabia.
* Must have access to the internet once a week to answer questions via an online link.
* Adults (18 - 64 years)

Exclusion Criteria:

* Being unable to walk.
* Pregnant or given birth in the last 12 months
* Scoring a high levels of physical activity on the international physical activity questionnaire - short form. An individual with more than 3000 MET minutes a week will be considered to have a high level of PA according to the survey authors

Primary outcomes:
measure: Quality of life (EQ-5D-5L) t1
timeFrame: Baseline week zero
measure: Quality of life (EQ-5D-5L) t2
timeFrame: Week 12
measure: Quality of life Short Form 36 Health Survey Questionnaire (SF-36) t1
timeFrame: Baseline week zero
measure: Quality of life Short Form 36 Health Survey Questionnaire (SF-36) t2
timeFrame: Week 12
Secondary outcomes:
measure: Anxiety t1
timeFrame: Baseline week zero
measure: Anxiety t2
timeFrame: Week 12
measure: Depression t1
timeFrame: Baseline week zero
measure: Depression t2
timeFrame: Week 12
measure: Exercise level (The International Physical Activity Questionnaires) (IPAQ) t1
timeFrame: Baseline week zero
measure: Exercise level (The International Physical Activity Questionnaires) (IPAQ) t2
timeFrame: Week 12
measure: Food frequency Epic FFQ t1
timeFrame: Baseline week zero
measure: Food frequency Epic FFQ t2
timeFrame: Week 12
measure: Cognitive functionality (Memory) t1
timeFrame: Baseline week zero
measure: Cognitive functionality (Memory) t2
timeFrame: Week 12
measure: Steps Smartwatch
timeFrame: Repeated weekly. Week 1
measure: Steps Smartwatch
timeFrame: Repeated weekly. Week 2
measure: Steps Smartwatch
timeFrame: Repeated weekly. Week 3
measure: Steps Smartwatch
timeFrame: Repeated weekly. Week 4
measure: Steps Smartwatch
timeFrame: Repeated weekly. Week 5
measure: Steps Smartwatch
timeFrame: Repeated weekly. Week 6
measure: Steps Smartwatch
timeFrame: Repeated weekly. Week 7
measure: Steps Smartwatch
timeFrame: Repeated weekly. Week 8
measure: Steps Smartwatch
timeFrame: Repeated weekly. Week 9
measure: Steps Smartwatch
timeFrame: Repeated weekly. Week 10
measure: Steps Smartwatch
timeFrame: Repeated weekly. Week 11
measure: Steps Smartwatch
timeFrame: Repeated weekly. Week 12
measure: Health Locus Control (Multidimensional Health Locus of Control form C- MHLC) t1
timeFrame: Baseline week zero
measure: Health Locus Control (Multidimensional Health Locus of Control form C- MHLC) t2
timeFrame: Week 12
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading
name: Daniel Lamport, PhD
role: PRINCIPAL_INVESTIGATOR
References: