Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/10/2020
Date assigned
21/10/2020
Last edited
22/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
In Ireland, the frequency of people living with is nearly double that of the global average, standing at 23%. Obesity is one of Irelands biggest public health challenges to date. The primary and most dangerous hazards associated with obesity include increased cardiovascular disease (CVD) risk, increased mortality, increased multi-morbidities, decreased quality of life and increased risk of mental health issues. Sedentary behaviour is linked closely to the development/maintenance of obesity. Personalised goals have been found to be effective in increasing physical activity in a number of studies. The purpose of this study is to examine whether weekly personalized goals, review and feedback can significantly reduce sedentary behaviour, reduce BMI and improve psychological outcomes in people living with obesity.

Who can participate?
People who are enrolled on the CLANN programme run by the Croi Heart and Stroke Charity in University College Hospital, Galway.

What does the study involve?
Participants will either be assigned to a control or intervention group for the duration of the study. All participants will participate in the base CLANN programme. In addition, the intervention group will receive weekly personalized sedentary behaviour goals. All participants will be asked to fill in questionnaires at the first visit and will be followed up over a 10-week period after which the same measures will be applied for follow-up data.

What are the possible benefits and risks of participating?
It is expected that this programme will increase the quality of life and health of participants. The risk to the safety of engaging in increased physical exercise is expected to be minimal compared with the risks associated with day to day life. The intervention involves advice given by health professionals on diet and physical activity and will be appropriate for the participants’ ability and integrated into their current lifestyle.

Where is the study run from?
The Croi Heart and Stroke Charity Building in Galway (Ireland)

When is the study starting and how long is it expected to run for?
From March 2017 to August 2017

Who is funding the study?
Investigator-initiated and funded

Who is the main contact?
Dr Jane Walsh
jane.walsh@nuigalway.ie

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jane Walsh

ORCID ID

http://orcid.org/0000-0001-5476-1348

Contact details

School of Psychology
NUI Galway
Galway
H91 EV56
Ireland
+353 91 493101
jane.walsh@nuigalway.ie

Type

Public

Additional contact

Dr Jane Walsh

ORCID ID

http://orcid.org/0000-0001-5476-1348

Contact details

School of Psychology
NUI Galway
Galway
H91 EV56
Ireland
+353 91 493101
jane.walsh@nuigalway.ie

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CLANN2018

Study information

Scientific title

Personalised goals using mobile technology to reduce sedentary behaviour in people living with obesity

Acronym

CLANN

Study hypothesis

To investigate whether weekly personalized goals, review, and feedback significantly reduce sedentary behaviour compared with standard advice/treatment in people living with obesity.

Ethics approval

1. Approved 16/12/2016, the Galway University Hospitals Clinical Research Ethics Committee (Room 59, 1st Floor, HR Building, Merlin Park, Hospital, Galway, EC5, Ireland; +353 (0)91 757631; colette.collins@hse.ie), ref: C.A.1652
2. Approved 15/02/2017, the School Research Ethics Committee (SREC), National University of Ireland Galway

Study design

Single-centre interventional randomized controlled trial with a 2x2 mixed analysis of variance design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Obesity, under consideration for bariatric surgery

Intervention

The study is employing a 2 groups (intervention and control) x 2 time-points (baseline, 10-week follow-up) mixed Analysis of Variance design to investigate the impact of a personalised goal-setting versus standard care on primary and secondary health outcomes in a group of patients enrolled in the CLANN Programme (https://croi.ie/about/our-programmes-services/croi-clann/) designed to reduce weight in patients living with obesity.

Baseline measures for all variable are assessed after which participants are randomly assigned, using simple randomisation, to either intervention or control condition.

Standard Care (control group): Standard care group will attend the CLANN programme for 10 weeks. The CLANN programme is a lifestyle intervention, run by the cardiac foundation Croì, which patients are referred to by their bariatric consultant. The programme consists of eight 2.5 hour sessions whereby the attendees have a brief check-up with their nurse and complete an exercise class, and then receive an educational seminar. The seminars include healthy eating, food labels, benefits of physical activity, psychological issues of obesity and maintaining change. No sedentary behaviour goals are given as part of the programme. On the penultimate week of CLANN, the control group’s sedentary behaviour and psychosocial variables will be measured again.

Intervention group: This group will participate in the same CLANN programme as the standard care group. However, they also receive weekly personalised goals to decrease their sedentary behaviour. These will be based on their baseline numbers. Sedentary behaviour is calculated as the amount of time spent sitting or lying, minus eight hours for sleep. Personalised goals are obtained by subtracting 10% from remaining sedentary time. Goals are increased/reduced incrementally by 10%. Participants in the personalised goals condition will wear the activPAL device again on week five to obtain goals based on updated objective data. Participants receive their weekly goals at the beginning of each CLANN session.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Sedentary behaviour assessed using the activPAL device at baseline and 10 weeks. The activPALTM is an accelerometer providing measures on the sitting/lying time and the number of up/down transitions in the time period.

Secondary outcome measures

1. Body Mass Index (BMI) calculated from measurements of weight and height at baseline and 10 weeks
2. Distress was measured using the Kessler Psychological Distress Scale (K10) at baseline and 10 weeks
3. Anxiety measured using the Overall Anxiety Severity and Impairment Scale (OASIS) at baseline and 10 weeks
4. Self-efficacy was measured using the General Self-Efficacy (GSE) scale at baseline and 10 weeks

Overall trial start date

07/03/2017

Overall trial end date

30/08/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age ≥18 years
2. Competent in the English language
3. Enrolled in the Croi CLANN Programme at University College Hospital Galway

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/03/2017

Recruitment end date

15/06/2017

Locations

Countries of recruitment

Ireland

Trial participating centre

Croi Heart and Stroke Charity
Croí House Moyola Lane Newcastle
Galway
H91 FF68
Ireland

Trial participating centre

School of Psychology
NUI Galway
Galway
H91 EV56
Ireland

Sponsor information

Organisation

National University of Ireland, Galway

Sponsor details

School of Psychology
Galway
H91 EV56
Ireland
+353 91 493101
jane.walsh@nuigalway.ie

Sponsor type

University/education

Website

www. nuigalway.ie

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

One publication of the pilot trial results is planned for January 2021, titled: Personalised Goals using mobile technology to Reduce Sedentary Behaviour people living with obesity: A Pilot Trial.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available as the research team at present do not have the mechanism to fully and confidently deidentify the large amount of data gathered. The data will be held on a secure virtual server at NUIG, and questionnaire data collected at baseline and follow-up will be stored in a secure locker in NUI Galway School of Psychology for 7 years in accordance with the data protection act.

Intention to publish date

30/01/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/10/2020: Internal review. 21/10/2020: Trial’s existence confirmed by Galway University Hospitals Clinical Research Ethics Committee.