Walking Interventions to Improve Quality of Life Among Adults With T2D in SA and the UK

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05894252
• Other study ID #: UReading walking interventions
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2023
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: University of Reading
• Contact: Daniel Lamport, PhD
• Phone: 01183785032
• Email: daniel.lamport[@]reading.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Quality of Life
• Type 2 Diabetes

Intervention

Other:
• Walking Interventions
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 a 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.

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (EQ-5D-5L) t1	The five-dimensional EuroQol scale will be used to assess the quality of life (EQ-5D-5L). The EQ-5D-5L is based on a descriptive system that consists of five dimensions, each capturing a different aspect of health-related quality of life. These dimensions are mobility, self-care, usual activities pain/discomfort, and anxiety/depression each dimension is rated on a five-level scale, which allows individuals to indicate their level of problems or impairment. The five levels are no problems, slight problems, moderate problems, severe problems, and extreme problems. The combination of responses creates a unique health state profile, which can be converted into a single index value representing overall health status. This index value ranges from 0 (representing the worst possible health state) to 1 (representing full health). Higher scores indicate a higher level of health-related quality of life.	Baseline week zero
Primary	Quality of life (EQ-5D-5L) t2	The five-dimensional EuroQol scale will be used to assess the quality of life (EQ-5D-5L). The EQ-5D-5L is based on a descriptive system that consists of five dimensions, each capturing a different aspect of health-related quality of life. These dimensions are mobility, self-care, usual activities pain/discomfort, and anxiety/depression each dimension is rated on a five-level scale, which allows individuals to indicate their level of problems or impairment. The five levels are no problems, slight problems, moderate problems, severe problems, and extreme problems. The combination of responses creates a unique health state profile, which can be converted into a single index value representing overall health status. This index value ranges from 0 (representing the worst possible health state) to 1 (representing full health). Higher scores indicate a higher level of health-related quality of life.	Week 12
Primary	Quality of life Short Form 36 Health Survey Questionnaire (SF-36) t1	A second measure of quality of life will be obtained by completing the Short Form 36 Health Survey Questionnaire (SF-36).The Short Form 36 Health Survey Questionnaire (SF-36) is a used as self-reported instrument assessing health-related quality of life (HRQoL). It consists of 36 questions measuring physical and mental health across eight dimensions. Physical health includes functioning, role limitations, pain, and general health perceptions. Mental health covers vitality, social functioning, role limitations, and mental health. Each dimension is scored from 0 to 100, with higher scores indicating better HRQoL.	Baseline week zero
Primary	Quality of life Short Form 36 Health Survey Questionnaire (SF-36) t2	A second measure of quality of life will be obtained by completing the Short Form 36 Health Survey Questionnaire (SF-36). The Short Form 36 Health Survey Questionnaire (SF-36) is a used as self-reported instrument assessing health-related quality of life (HRQoL). It consists of 36 questions measuring physical and mental health across eight dimensions. Physical health includes functioning, role limitations, pain, and general health perceptions. Mental health covers vitality, social functioning, role limitations, and mental health. Each dimension is scored from 0 to 100, with higher scores indicating better HRQoL.	Week 12
Secondary	Anxiety t1	The Generalized Anxiety Disorder 7-item scale (GAD-7) is a self-report questionnaire designed to assess the severity of generalized anxiety disorder symptoms. It consists of seven questions that capture common anxiety symptoms experienced over the past two weeks. Individuals rate the frequency of symptoms on a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21, with higher scores indicating greater anxiety severity.	Baseline week zero
Secondary	Anxiety t2	The Generalized Anxiety Disorder 7-item scale (GAD-7) is a self-report questionnaire designed to assess the severity of generalized anxiety disorder symptoms. It consists of seven questions that capture common anxiety symptoms experienced over the past two weeks. Individuals rate the frequency of symptoms on a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21, with higher scores indicating greater anxiety severity.	Week 12
Secondary	Depression t1	An assessment of depression symptoms is conducted with the Patient Health Questionnaire 9-item scale (PHQ-9). It consists of nine questions that capture common depressive symptoms experienced over the past two weeks. Each item is rated on a scale from 0 (not at all) to 3 (nearly every day), reflecting the frequency and intensity of symptoms. The total score ranges from 0 to 27, with higher scores indicating greater depression severity.	Baseline week zero
Secondary	Depression t2	An assessment of depression symptoms is conducted with the Patient Health Questionnaire 9-item scale (PHQ-9). It consists of nine questions that capture common depressive symptoms experienced over the past two weeks. Each item is rated on a scale from 0 (not at all) to 3 (nearly every day), reflecting the frequency and intensity of symptoms. The total score ranges from 0 to 27, with higher scores indicating greater depression severity.	Week 12
Secondary	Exercise level (The International Physical Activity Questionnaires) (IPAQ) t1	Physical activity levels are assessed using the International Physical Activity Questionnaires (IPAQ). A number of versions of the IPAQ are available, including the IPAQ-LF (long form) and IPAQ-SF (short form). The IPAQ-LF collects detailed information about work, transportation, chores, and leisure activities and provides an estimate of total physical activity. IPAQ-SF focuses on walking, moderate, and vigorous activities, giving domain-specific and total estimates. This study will use a short-form version of the IPAQ (IPAQ-SF). The total score for IPAQ varies based on reported activity levels across domains. It can range from 0 (no activity) to higher values indicating significant weekly physical activity.	Baseline week zero
Secondary	Exercise level (The International Physical Activity Questionnaires) (IPAQ) t2	Physical activity levels are assessed using the International Physical Activity Questionnaires (IPAQ). A number of versions of the IPAQ are available, including the IPAQ-LF (long form) and IPAQ-SF (short form). The IPAQ-LF collects detailed information about work, transportation, chores, and leisure activities and provides an estimate of total physical activity. IPAQ-SF focuses on walking, moderate, and vigorous activities, giving domain-specific and total estimates. This study will use a short-form version of the IPAQ (IPAQ-SF). The total score for IPAQ varies based on reported activity levels across domains. It can range from 0 (no activity) to higher values indicating significant weekly physical activity.	Week 12
Secondary	Food frequency Epic FFQ t1	Food Frequency Epic FFQ is a questionnaire that assesses dietary intake. It collects data on food frequency and portion sizes, estimating nutrient and food group intakes. Participants report average consumption over a defined period.	Baseline week zero
Secondary	Food frequency Epic FFQ t2	Food Frequency Epic FFQ is a questionnaire that assesses dietary intake. It collects data on food frequency and portion sizes, estimating nutrient and food group intakes. Participants report average consumption over a defined period.	Week 12
Secondary	Cognitive functionality (Memory) t1	The Memory Intrusion - TB1&TB2 paradigm is a widely used method to study memory retrieval and false memory effects. Participants memorize a list of words and then indicate if words in a second list were present in the original (old) or not (new). The second list includes related foils, leading to false memories. This paradigm sheds light on memory processes and factors affecting accuracy in cognitive.	Baseline week zero
Secondary	Cognitive functionality (Memory) t2	The Memory Intrusion - TB1&TB2 paradigm is a widely used method to study memory retrieval and false memory effects. Participants memorize a list of words and then indicate if words in a second list were present in the original (old) or not (new). The second list includes related foils, leading to false memories. This paradigm sheds light on memory processes and factors affecting accuracy in cognitive.	Week 12
Secondary	Steps Smartwatch	Participants are required to log in to a link once a week and self-report their total steps for the week. This simple process allows for regular tracking of participants' physical activity levels, promoting engagement and accountability in monitoring their step counts.	Repeated weekly. Week 1
Secondary	Steps Smartwatch	Participants are required to log in to a link once a week and self-report their total steps for the week. This simple process allows for regular tracking of participants' physical activity levels, promoting engagement and accountability in monitoring their step counts.	Repeated weekly. Week 2
Secondary	Steps Smartwatch	Participants are required to log in to a link once a week and self-report their total steps for the week. This simple process allows for regular tracking of participants' physical activity levels, promoting engagement and accountability in monitoring their step counts.	Repeated weekly. Week 3
Secondary	Steps Smartwatch	Participants are required to log in to a link once a week and self-report their total steps for the week. This simple process allows for regular tracking of participants' physical activity levels, promoting engagement and accountability in monitoring their step counts.	Repeated weekly. Week 4
Secondary	Steps Smartwatch	Participants are required to log in to a link once a week and self-report their total steps for the week. This simple process allows for regular tracking of participants' physical activity levels, promoting engagement and accountability in monitoring their step counts.	Repeated weekly. Week 5
Secondary	Steps Smartwatch	Participants are required to log in to a link once a week and self-report their total steps for the week. This simple process allows for regular tracking of participants' physical activity levels, promoting engagement and accountability in monitoring their step counts.	Repeated weekly. Week 6
Secondary	Steps Smartwatch	Participants are required to log in to a link once a week and self-report their total steps for the week. This simple process allows for regular tracking of participants' physical activity levels, promoting engagement and accountability in monitoring their step counts.	Repeated weekly. Week 7
Secondary	Steps Smartwatch	Participants are required to log in to a link once a week and self-report their total steps for the week. This simple process allows for regular tracking of participants' physical activity levels, promoting engagement and accountability in monitoring their step counts.	Repeated weekly. Week 8
Secondary	Steps Smartwatch	Participants are required to log in to a link once a week and self-report their total steps for the week. This simple process allows for regular tracking of participants' physical activity levels, promoting engagement and accountability in monitoring their step counts.	Repeated weekly. Week 9
Secondary	Steps Smartwatch	Participants are required to log in to a link once a week and self-report their total steps for the week. This simple process allows for regular tracking of participants' physical activity levels, promoting engagement and accountability in monitoring their step counts.	Repeated weekly. Week 10
Secondary	Steps Smartwatch	Participants are required to log in to a link once a week and self-report their total steps for the week. This simple process allows for regular tracking of participants' physical activity levels, promoting engagement and accountability in monitoring their step counts.	Repeated weekly. Week 11
Secondary	Steps Smartwatch	Participants are required to log in to a link once a week and self-report their total steps for the week. This simple process allows for regular tracking of participants' physical activity levels, promoting engagement and accountability in monitoring their step counts.	Repeated weekly. Week 12
Secondary	Health Locus Control (Multidimensional Health Locus of Control form C- MHLC) t1	The MHLC-C assesses health control beliefs for individuals with a medical condition across four subscales: Internal, Chance, Doctors, and Others. Scores range from 6 to 36 per subscale, and the overall score spans 18 to 108. Higher Internal scores indicate increased belief in personal control over health outcomes. Elevated scores on Chance, Doctors, and Others suggest reliance on external factors, with varied interpretations. A higher Doctors score may imply trust in medical professionals, while raised Chance or Others scores may indicate a perceived lack of personal control. Overall, higher MHLC-C scores denote a more external health locus of control, attributing health outcomes to factors beyond personal control.	Baseline week zero
Secondary	Health Locus Control (Multidimensional Health Locus of Control form C- MHLC) t2	The MHLC-C assesses health control beliefs for individuals with a medical condition across four subscales: Internal, Chance, Doctors, and Others. Scores range from 6 to 36 per subscale, and the overall score spans 18 to 108. Higher Internal scores indicate increased belief in personal control over health outcomes. Elevated scores on Chance, Doctors, and Others suggest reliance on external factors, with varied interpretations. A higher Doctors score may imply trust in medical professionals, while raised Chance or Others scores may indicate a perceived lack of personal control. Overall, higher MHLC-C scores denote a more external health locus of control, attributing health outcomes to factors beyond personal control.	Week 12