Walking Before or After Breakfast - Which is Better to Improve Health in Overweight Individuals?

NCT06240663 | Completed

• 1 other identifier: 20/SPS021
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effectiveness of a home-based walking-based exercise intervention undertaken in the fed or fasted state to improve glycaemic control in overweight and obese individuals. This study will evaluate the adherence and compliance to this "real-world" exercise programme that requires no face-to-face contact with the research team. It is also hypothesised that individuals who exercise before breakfast (fasted) will see greater improvements in glycaemic control than those who exercise after breakfast.

Conditions

Metabolic Disease; Insulin Resistance

Outcome Measures

Primary Outcomes (2)

• Adhearance

  Do individuals complete all the exercise sessions.

  Number of exercise sessions are counted. There are 4 exercise sessions prescribed per week for 12 weeks.

• Compliance

  Do participants complete each exercise session as prescribed?

  HR and duration are measured during every exercise session to calculate this. There are 4 exercise sessions prescribed per week for 12 weeks.

Secondary Outcomes (5)

• HbA1c

  0 and 12 weeks.

• Waist circumference

  0 and 12 weeks.

• Time in Range for Plasma Glucose

  Days 0 - 14 and days 77 - 91

• Alanine Transferase

  0 and 12-weeks.

• Hip Circumference

  0 and 12-weeks.

Study Arms (2)

Fasted

EXPERIMENTAL

Half the participants completed this exercise intervention in the fasted state.

Behavioral: Exercise

Fed

EXPERIMENTAL

Half the participants completed this exercise intervention in the fed state.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Both groups complete the exercise intervention identically, but one is in the fasted state and one is in the fed state.

Fasted; Fed

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 20-60 years
• BMI \>28 kg.m-2
• Not currently using any anti-diabetes medication
• Physically inactive (performing less than two 30 min structured exercise sessions per week for the last year)
• Not pregnant or currently breast feeding
• Pre-menopausal or peri-menopausal
• Not currently involved in a weight loss programme or using weight loss medication

You may not qualify if:

• Involved in regular exercise (engaged in more than 3 sessions of structured exercise of \>30 min per week)
• Currently using anti-diabetes medication (e.g. insulin, metformin)
• Pregnant or breast feeding
• Currently engaged in active weight loss programme or using weight loss medication
• Diagnosed with chronic kidney disease
• Post-menopausal

Sponsors & Collaborators

• Liverpool John Moores University: lead
• Diabetes UK: collaborator

Study Sites (1)

Liverpool John Moores University

Liverpool, Merseyside, L3 3AF, United Kingdom

Location

MeSH Terms

Conditions

Metabolic Diseases; Insulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sam O Shepherd, PhD

  Liverpool John Moores University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: February 5, 2024
• Study Start: May 1, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: February 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)