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

NCT05894252 | Completed

• 1 other identifier: UReading walking interventions
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes; Quality of Life

Keywords

Type 2 Diabetes; Intervention; Quality of life; Wellbeing

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (24)

• Anxiety t1

  Baseline week zero

• Anxiety t2

  Week 12

• Depression t1

  Baseline week zero

• Depression t2

  Week 12

• Exercise level (The International Physical Activity Questionnaires) (IPAQ) t1

  Baseline week zero

Study Arms (2)

Experimental walking group

EXPERIMENTAL

Participants in the intervention group will need to engage in a 30-minute walk on five days every week for a duration of 12 weeks. To assist them in monitoring their activity and complying with the intervention guidelines, participants will receive a complimentary fitness watch. Weekly step counts will be collected from participants, who will report their data through a researcher-provided online link. The watch will come with an accompanying app for participants to access their data, but the researchers will not have access to this app.

Other: Walking Interventions

Control

NO INTERVENTION

In the control group, participants will not be required to complete the 30 minutes of walking every day. Instead, they will be asked to continue with their daily routines and usual level of physical activity. participants will receive a complimentary fitness watch. Weekly step counts will be collected from participants, who will report their data through a researcher-provided online link. The watch will come with an accompanying app for participants to access their data, but the researchers will not have access to this app.

Interventions

Walking Interventions OTHER

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.

Experimental walking group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead

Study Sites (1)

University of Reading

Reading, Berkshire, RG66AL, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Daniel Lamport, PhD

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Daniel Lamport

Model Details: There are 2 groups (i) walking intervention (ii) control group.

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: June 14, 2023
• Primary Completion: March 20, 2024
• Study Completion: March 20, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

GB (1)