The effect of family-based physical activity promotion on child physical activity: an evaluation of the Families Reporting Every Step to Health (FRESH) programme

ISRCTN	ISRCTN12789422
DOI	https://doi.org/10.1186/ISRCTN12789422
Protocol serial number	N/A
Sponsor	University of Cambridge
Funder	National Institute for Health Research

Submission date: 16/03/2016
Registration date: 06/12/2016
Last edited: 20/01/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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’, virtual badges, collectable playing cards, and other activity challenges. The aim of this study is to investigate the effectiveness of an online delivered family-based physical activity promotion programme at promoting physical activities in children and their families living in Norfolk and Suffolk.

Who can participate?
Children in school years 3-6 who live in Norfolk/Suffolk and their families.

What does the study involve?
Feasibility 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.

Pilot study:
Participants are randomly allocated to one of three groups:
1. Intervention website’ arm – all participating family members will be given pedometers, have access to the FRESH website to help them work together towards their weekly goals.
2. Pedometer-only’ arm – all participating family members will be given pedometers and readily available information leaflets (e.g., by NHS, Change4Life), but they do not receive access to the FRESH website.
3. Standard care control – these families receive no treatment.
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.

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 December 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

Contact information

Dr Esther van Sluijs
Scientific

MRC Epidemiology Unit & CEDAR
University of Cambridge School of Clinical Medicine
Cambridge
CB2 0QQ
United Kingdom

ORCID ID	0000-0001-9141-9082
Phone	+44 1223 330315
Email	esther.vansluijs@mrc-epid.cam.ac.uk

Study information

Primary study design	Interventional
Study design	Feasibility study: Randomised parallel-group feasibility study Pilot study: Three-arm randomised controlled pilot study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	FRESH
Study objectives	Current hypothesis: The family-based FRESH interventions promotes moderate-to-vigorous physical activity in children and their families living in Norfolk/Suffolk. Previous 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(s)	Feasibility study: University of Cambridge’s School of Humanities and Social Sciences Ethics Committee, 21/02/2017 Pilot study: University of Cambridge’s School of Humanities and Social Sciences Ethics Committee, 24/01/2018
Health condition(s) or problem(s) studied	Prevention of disease
Intervention	Current interventions as of 13/02/2018: 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 country) using Stata; research staff will use this to allocate eligible families to either the intervention website, pedometer-only, or standard care groups using a 1:1:1 ratio: Group 1 - ‘Intervention website’ arm – all participating family members will be given pedometers, have access to the FRESH website to help them work together towards their weekly goals. Group 2 - ‘Pedometer-only’ arm – all participating family members will be given pedometers and readily available information leaflets (e.g., by NHS, Change4Life), but they do not receive access to the FRESH website. Group 3 - Standard care control – these families receive no treatment. All participants (family members) in all groups are followed up after eight weeks and one year with accelerometers and a range of questionnaires and physical tests. Previous interventions: 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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	Current secondary outcome measures as of 13/02/2018: 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, 8 weeks later, and ~1 year 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. 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) 10. 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) 11. 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) 12. 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) 13. 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) 14. 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) 15. Quality of life is measured using EQ-5D & CHU-9D questionnaire at baseline and 8 weeks (feasibility study) and baseline, 8 weeks and ~1 year (pilot study) 16. Intervention delivery costs is measured using study billing records throughout the feasibility and pilot studies 17. 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) 18. Screen time is measured using a questionnaire at baseline and 8 weeks (feasibility study) and baseline, 8 weeks and ~1 year (pilot study) Participating children: 1. 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) (Outcome measure removed 08/11/2018) 2. Basic psychological needs are measured using a questionnaire at baseline and 8 weeks (feasibility study) and baseline, 8 weeks and ~1 year (pilot study) Previous 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)
Completion date	31/12/2019

Eligibility

Participant type(s)	Healthy volunteer
Age group	Mixed
Sex	All
Target sample size at registration	320
Key inclusion criteria	Current inclusion criteria as of 13/02/2018: 1. Child between school years 3-6 living in Norfolk/Suffolk 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 5. Internet access Previous 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/01/2017
Date of final enrolment	30/09/2018

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Cambridge

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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be shared with anyone outside of the study’s research team. The data will be held at the MRC Epidemiology Unit at the University of Cambridge.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	feasibility study results	09/02/2019	25/02/2019	Yes	No
Results article	results	22/09/2020	24/09/2020	Yes	No
Results article		01/09/2021	20/01/2023	Yes	No
Protocol article	pilot study protocol	28/10/2019	22/10/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

20/01/2023: Publication reference added.
22/10/2020: Publication reference added.
24/09/2020: Publication reference added.
04/07/2019: The intention to publish date was changed from 30/12/2019 to 01/05/2020.
14/06/2019: The overall trial end date was changed from 01/10/2019 to 31/12/2019.
25/02/2019: Publication reference added.
08/11/2018: The following changes were made to the trial record:
1. In all fields the trial setting was changed from "rural areas of Norfolk/Suffolk" to "Norfolk/Suffolk".
2. In all fields the follow-up timepoint was changed from "1 year" to "~1 year".
3. The secondary outcome measures were updated.
26/07/2018: The recruitment end date was changed from 01/05/2018 to 30/09/2018.
22/02/2018: The participant level data sharing statement has been added.
13/02/2018: After the completion of the FRESH feasibility study there has been modifications made to the protocol. These have been approved by the NIHR. The overall trial end date has been updated from 01/06/2019 to 01/10/2019. The intention to publish date has been updated from 30/11/2017 to 30/12/2019. The plain English summary has been updated.
26/09/2017: Ethics information has been added.