Condition category
Not Applicable
Date applied
16/03/2016
Date assigned
06/12/2016
Last edited
26/09/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A low level of physical activity in children puts them at risk of obesity, mental health problems and poor development. It has been found that in general children’s physical activity levels are low and get worse as they get older, particularly in rural areas. UK-based data shows that only half of 7-year olds meet physical activity guidelines, while in adolescence physical activity is estimated to decline by 7% per year. FRESH (Families Reporting Every Step to Health) is a family-based programme delivered via an online platform which was developed with families to improve physical activity levels. The programme uses goal setting and rewards in order to encourage family relations by getting families to be active together. It involves children and their families) virtually travelling across the world by accumulating steps throughout the week. Each week children and/or families access the FRESH website to help them set goals, log their steps, and monitor their progress towards virtually reaching a new city. As they achieve their weekly goals they will receive rewards, which include fun facts about the cities they ‘visit’ and other activity challenges. The aim of this study is to investigate the effectiveness of FRESH at promoting physical activities in 8-10 year-old children and their families living in rural Norfolk.

Who can participate?
Children aged between 8-10 years who live in a rural area of Norfolk and their families.

What does the study involve?
In the first part of the study, participants are randomly allocated to one of two groups. For those in the first group, all participating family members are given pedometers (step counters) to wear to reach their goals using FRESH. For those in the second group, only children wear the pedometers and receive support from their families to reach their goals. All participants (family members) in both groups are measured at the start of the study and followed up after eight weeks with accelerometers and a range of questionnaires and physical tests.
In the second part of the study, participants are randomly allocated to one of three groups. For those in the first group, all participating family members are given pedometers (step counters) to wear to reach their goals using FRESH. For those in the second group, only children wear the pedometers and receive support from their families to reach their goals. For those in the third group (standard care control), participants do not receive access to the FRESH website. All participants (family members) in all three groups are measured at the start of the study and followed up after eight weeks and 1-year with accelerometers and a range of questionnaires and physical tests. At the start of the study and then after eight weeks, participants have their physical activity measured using data collected from the pedometers.

What are the possible benefits and risks of participating?
Participants may benefit from increasing their levels of physical activity, which could potentially have long term benefits to participants’ health. There are no anticipated risks involved with participating.

Where is the study run from?
The study is run from University of Cambridge and takes place in the community (UK)

When is the study starting and how long is it expected to run for?
September 2016 to June 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Esther van Sluijs
esther.vansluijs@mrc-epid.cam.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Esther van Sluijs

ORCID ID

http://orcid.org/0000-0001-9141-9082

Contact details

MRC Epidemiology Unit & CEDAR
University of Cambridge School of Clinical Medicine
Cambridge
cb2 0qq
United Kingdom
+44 1223 330315
esther.vansluijs@mrc-epid.cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The impact of a family-based physical activity promotion programme on child physical activity: Feasibility and pilot of the Families Reporting Every Step to Health (FRESH) intervention

Acronym

FRESH

Study hypothesis

The family-based FRESH interventions promotes moderate-to-vigorous physical activity in 8-10 year-old children and their families living in rural Norfolk.

Ethics approval

University of Cambridge’s School of Humanties and Social Sciences Ethics Committee, 21/02/2017

Study design

Feasibility study:
Randomised parallel-group feasibility study

Pilot study:
Three-arm randomised controlled pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Prevention of disease

Intervention

Feasibility study:
A statistician will generate a randomisation list (stratifying by individual level socio-economic status) using Stata; research staff will use this to allocate eligible families to either family or child-only group using a 1:1 ratio:

Group 1 – ‘Family’: This involves all participating family members wearing pedometers and working together towards goals using the intervention website.
Group 2 – ‘Child only’: This involves only the child wearing a pedometer, setting individual goals, and receiving support from other family members using the intervention website.

All participants (family members) in both groups are followed up after eight weeks with accelerometers and a range of questionnaires and physical tests.

Pilot study:
A statistician will generate a randomisation list (stratifying by individual level socio-economic status) using Stata; research staff will use this to allocate eligible families to either a family, child-only, or standard care group using a 1:1:1 ratio:

Group 1 – ‘Family’: This involves all participating family members wearing pedometers and working together towards goals using the intervention website.
Group 2 – ‘Child only’: This involves only the child wearing a pedometer, setting individual goals, and receiving support from other family members using the intervention website.
Group 3 – ‘Control’: This involves 'standard care'; no intervention will be implemented and participants receive no access to the intervention website.

All participants (family members) in both groups are followed up after eight weeks and one year with accelerometers and a range of questionnaires and physical tests.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Child’s level of moderate-to-vigorous physical activity (MVPA) is measured using an accelerometer at baseline and 8 weeks (feasibility study) and baseline, 8 weeks and 1 year (pilot study).

Secondary outcome measures

All participating family members:
1. Daily average level of moderate-to-vigorous physical activity (MVPA) is measured in minutes using an accelerometer at baseline and 8 weeks (feasibility study) and baseline, 8 weeks and 1 year (pilot study)
2. Daily sedentary (SED) behaviour is measured in minutes using an accelerometer
3. Week/weekend MVPA/SED is measured using an accelerometer at baseline and 8 weeks (feasibility study) and baseline, 8 weeks and 1 year (pilot study)
4. Waist circumference is measured using measuring tape at baseline and 8wks later for the feasibility study and baseline, 8wks later, and 1yr-post baseline for pilot study.
5. Blood pressure is measured using blood pressure monitor (Omron) at baseline and 8 weeks (feasibility study) and baseline, 8 weeks and 1 year (pilot study)
6. Aerobic fitness is measured using sub-maximal step test at baseline and 8 weeks (feasibility study) and baseline, 8 weeks and 1 year (pilot study)
7. Family co-participation in physical activity is measured using The Activity Support Scale for Multiple Groups (parent/child version) at baseline and 8 weeks (feasibility study) and baseline, 8 weeks and 1 year (pilot study)
8. Activity location is measured using GPS (Waist-worn Qstarz BT-Q1000XT) at baseline and 8 weeks (feasibility study) and baseline, 8 weeks and 1 year (pilot study)
9. Executive function is measured using the Dimensional Change Card Sort and Flanker task at baseline and 8 weeks (feasibility study) and baseline, 8 weeks and 1 year (pilot study)
10. Family functioning is measured using the Fictional Family Holiday paradigm at baseline and 8 weeks (feasibility study) and baseline, 8 weeks and 1 year (pilot study)
11. Family social support is measured using The Activity Support Scale for Multiple Groups – parent/child version at baseline and 8 weeks (feasibility study) and baseline, 8 weeks and 1 year (pilot study)
12. Family social norms for physical activity is measured using The Activity Support Scale for Multiple Groups – parent/child version at baseline and 8 weeks (feasibility study) and baseline, 8 weeks and 1 year (pilot study)
13. Physical activity awareness is measured using the ‘Meeting guidelines’ self-report measure at baseline and 8 weeks (feasibility study) and baseline, 8 weeks and 1 year (pilot study)
14. Physical activity self-efficacy is measured using self-efficacy for physical activity Scale at baseline and 8 weeks (feasibility study) and baseline, 8 weeks and 1 year (pilot study)
15. Motivation for physical activity is measured using 12-item physical activity motivation questionnaire at baseline and 8 weeks (feasibility study) and baseline, 8 weeks and 1 year (pilot study)
16. Quality of life is measured using EQ-5D & EQ5D-Y questionnaire at baseline and 8 weeks (feasibility study) and baseline, 8 weeks and 1 year (pilot study)
17. Parenting behaviours is measured using Transformational Parenting Questionnaire at baseline and 8 weeks (feasibility study) and baseline, 8 weeks and 1 year (pilot study)
18. Intervention delivery costs is measured using study billing records throughout the feasibility and pilot studies
19. Family out of pocket physical activity expenditure is measured using a questionnaire at baseline and 8 weeks (feasibility study) and baseline, 8 weeks and 1 year (pilot study)

Overall trial start date

01/09/2016

Overall trial end date

01/06/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Child age 8-10 years living in a rural location in Norfolk OR person living in the main household of the index child (irrespective of age or relationship)
2. Participation of index child and at least one adult responsible for their care and living in their main household is required (participation of the wider family is encouraged, but not required)
3. Sufficient understanding of the English language to understand recruitment/intervention materials, verbal description of procedures, and complete questionnaires
4. Index child able to take part in at least light physical activity

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

Target number of participants

Approximately 80 (based on 20 families with 4 members per family) and 240 (based on 60 families with 4 members per family) participants for the feasibility and pilot studies, respectively.

Participant exclusion criteria

No exclusion criteria

Recruitment start date

01/01/2017

Recruitment end date

01/05/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Cambridge
Cambridge Biomedical Campus School of Clinical Medicine
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

University of Cambridge

Sponsor details

School of Clinical Medicine
Addenbrookes Hospital
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned submission of papers on intervention development and feasibility; family physical activity assessment; context of family physical activity; and a grant and/or paper on pilot evaluation.

Intention to publish date

30/11/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/09/2017: Ethics information has been added.