Digitally Delivered Exercise in Helping People to Move More | NCT05918926

Studies
Digitally Delivered Exercise in Helping People to Move More

NCT05918926

Sponsor

Bangor University

Status

Unknown status

Last Update Posted

Jun 26, 2023Actual

Enrollment

96Estimated

Phase

Not Applicable

Conditions

Obesity

Interventions

Exercise

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 18, 2022Actual

Primary Completion Date

Jul 1, 2023Estimated

Completion Date

Aug 1, 2023Estimated

First Submitted Date

Jun 15, 2023

First Submission Date that Met QC Criteria

Jun 15, 2023

First Posted Date

Jun 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2023

Last Update Posted Date

Jun 26, 2023Actual

Name	Class
Betsi Cadwaladr University Health Board	OTHER_GOV
Salaso Health Solutions Ltd	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main objective of this study is to examine the influence of the digital exercise prescription platform in increasing habitual physical activity in people on a weight management programme.

Detailed Description

Participants will be provided with individualised exercise training from exercise specialists. Participants will be recruited from the BCUHB NHS KindEating programme for people who have obesity (BMI of >30 kg/m2). Participants will be recruited remotely, via their KindEating dietitian. The assessments and exercise programme will be conducted remotely in the participants' own home.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise	Experimental	Remote 12-week exercise intervention	Behavioral: Exercise
Control/Routine Care	No Intervention	No exercise intervention, continue with routine care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise	Behavioral	Individualised remote exercise intervention	Exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Habitual physical activity	Global Physical Activity Questionnaire	Change between baseline and 3 months (post intervention)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Enrolled into the KindEating programme with BCUHB
≥ 18 years of age
Able to provide written informed consent

Exclusion Criteria:

Any uncontrolled medical condition that is exacerbated by exercise
Unstable angina, unstable or acute heart failure, new or uncontrolled arrhythmias, resting or uncontrolled tachycardia, uncontrolled hypertension >180/100 (in either), symptomatic hypotension, febrile illness, acute uncontrolled psychiatric illness, other rapidly progressing terminal illness, uncontrolled diabetes >16.7mmol, patient's currently undergoing anti-biotic treatment for cellulitis, acute infections active foot ulceration
Inability to provide informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sophie E Harrison, PhD	Contact	01248 382303		s.harrison@bangor.ac.uk
Jamie H Macdonald, PhD	Contact	01248 383272		j.h.macdonald@bangor.ac.uk

Overall Officials

Name	Affiliation	Role
Sophie E Harrison, PhD	Bangor University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Betsi Cadwaladr University Health Board	Recruiting	Bangor	North Wales		United Kingdom

Type	Date	Date Unknown
Release	Feb 5, 2025
Reset	Feb 26, 2025

Submission Tracking

Estimated Results First Submitted Date

Feb 5, 2025

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 5, 2025			Feb 26, 2025

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D009043	Motor Activity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided