Childhood ObesityPhase 3OFTENNCT02675699
The Optimising Family Engagement in HENRY (OFTEN) Study
A Phase 3 study testing Optimisation + HENRY and HENRY as standard in people with Childhood Obesity, run by University of Leeds at 1 site in United Kingdom.
Trial summary
This study will test whether parent engagement (recruitment, attendance) in a Childhood obesity prevention programme (HENRY) can be improved in local authorities randomised to receive an Optimisation intervention (in addition to standard HENRY) compared to those continuing to deliver the programme as standard. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Optimisation + HENRY and HENRY as standard
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Oct 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Local authorities:
- Local authorities providing data from at least 4 Children's Centres
- Courses delivered by trained staff who have been certified by HENRY
- Children's Centres:
- At least one course to be delivered per Centre per year
- Sites with a history of providing process data for the previous year.
- There will be no exclusions based on the demographics of Children's Centres, but location will be monitored to ensure inclusion of those with diverse social and environmental characteristics.
- -
Who cannot join
- Local authorities:
- Areas which have plans to decommission the HENRY intervention during the course of the trial; or who are not planning on running HENRY programmes during the trial period.
- Children's Centres:
- Centres where ethnography has taken place during Study 2
- Centres who are not planning on running HENRY programmes during the trial period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Implementation Optimisation Intervention Aimed at Increasing Parent Engagement in HENRY, a Childhood Obesity Prevention Programme: a Cluster Randomised Controlled Trial
This study will test whether parent engagement (recruitment, attendance) in a Childhood obesity prevention programme (HENRY) can be improved in local authorities randomised to receive an Optimisation intervention (in addition to standard HENRY) compared to those continuing to deliver the programme as standard.
Read the detailed description
BACKGROUND: Rising rates of obesity in preschool children are alarming and emphasise the need for evidence-based approaches to prevent obesity, which can be successfully implemented in communities. Although robust, theory-based prevention programmes exist, it is often a challenge to get parents to attend them and adopt positive behaviour changes in their families.
AIM: To evaluate the effectiveness of a recently developed 'Optimisation intervention' to optimise parent engagement in a community based obesity prevention programme 'HENRY', using routinely collected process data from existing sites commissioned to deliver HENRY in the UK
DESIGN: Multi-centre, cluster randomised controlled trial. As research will judge the ability of local authorities and their Centres to optimise implementation of HENRY, a cluster randomised design, has been chosen with local authority as the unit of randomisation. Local authorities will be randomised in a 1:1 allocation ratio (HENRY+ Optimisation Intervention; HENRY alone control) by a statistician at Leeds CTRU, using minimisation algorithm with random element, stratifying on baseline level of implementation (proportion of Centres meeting none of the 2 primary outcome implementation criteria/ meeting 1 or 2 of the criteria)) size of local authorities (number of Children's Centres (< 10/ ≥10)) and area deprivation (≤10% />10% ranking within Index of Multiple Deprivation at the Lower Layer Super Output Area).
Consent to participate will be sought at the cluster level (local authorities) and from the Centres within each local authority using an opt-out approach.
CONTROL ARM: HENRY delivered as standard. HENRY (Health, Exercise, Nutrition for the Really Young) is an 8-week programme delivered in Children's Centres (CCs), aiming to provide parents with skills and knowledge to support healthy lifestyles in preschool children and their families. It was set up in 2006 with Department of Health support aimed at reversing rising trends in school entry age obesity. HENRY is currently delivered in 32 local areas across England and Wales by trained health and community practitioners.
ACTIVE ARM: HENRY as standard plus an optimisation intervention to enhance parent engagement (recruitment and attendance) in the 8 week programme. A tailored 'Optimisation' intervention has been developed with a NIHR funds (CDF 2014-07-052) to support local authorities and Children's Centres to promote HENRY implementation, based on observations of positive deviants, interviews with Children Centre staff and other stakeholders, and input from parents. The resulting optimisation package is a multi-component intervention implemented at multi-levels (local authorities, Centres, parents). Precise details can not currently be disclosed to do risk of contamination.
ANALYSIS: Primary outcome analysis will be on the intention-to treat Population using a 3-level hierarchical model, with courses (or participants) nested within CCs within LA, adjusting for randomization minimisation variables. Differences in parent engagement, corresponding 95% CI, p-values and ICCs will be reported.
- Conditions
- Childhood Obesity
- Being tested
- Optimisation + HENRY, HENRY as standard
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimisation + HENRYBehavioural
HENRY HENRY is an 8-week childhood obesity prevention programme delivered in Children's Centres in the UK by trained practitioners, aiming to provide parents with skills and knowledge to support healthy lifestyles in preschool children and their families. The programme aims to build parents' skills, knowledge and confidence to change old habits and provide healthier nutrition.
OPTIMISATION A tailored 'Optimisation' intervention has being developed to support local authorities and Children's Centres to promote HENRY implementation, based on an ethnography of Children Centres, including interviews with staff and other stakeholders and input from parents. Development was underpinned by strong theories of behaviour change and will be guided by the intervention planning framework; the Behaviour Change wheel using a systematic approach. Strategies have been developed to improve parent motivation to enrol on to HENRY and promote parent self-efficacy to continue to attend.
HENRY as standardBehavioural
Local Authorities / Children's Centres that are assigned to the control group will continue with standard HENRY practice. Current HENRY QA practice involves the review of process data by HENRY central office with provision of written and oral feedback. This will continue in both trial arms and will be monitored.
| Study group | Role | What they receive |
|---|---|---|
| Optimisation + HENRY | Experimental | Not described Receives: Behavioral: Optimisation + HENRY |
| HENRY as standard | Active comparator | Not described Receives: Behavioral: HENRY as standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of parents engaging with the HENRY programme measured using Centre level process data
Centre level data: A combined outcome of parent engagement based on the number of parents recruited per course and the attendance rate. In order to be effective, courses need improve parent engagement and retain parents to continue on the course.
Measured: 12 month post randomisation (allowing 3 months for Optimisation intervention implementation and collecting data from 1- 2 HENRY courses per site).
Secondary outcomes (5)
Level of parent compliance to HENRY content measured via self-reported changes in frequency that fruits and vegetables are consumed each day by infants
Compliance will be measured using a proxy of parent reported frequency of consumption of fruits /vegetables by children/ day/ course. This will be assessed at the parent-level as a binary variable
Measured: 12 months post randomisation
Parenting self-efficacy
Adapted Parenting Self-Agency Measure
Parenting self-agency measure (Dumka 1996)
Measured: 12 months post randomisation
Eating behaviours
Golan (1998) Family Eating and Activity Habits Questionnaire
Measured: 12 months post randomisation
Family activity
Bespoke HENRY brief activity questionnaire
Measured: 12 months post randomisation
Daily intake of key indicator foods in infants
Modified validated Food Frequency Questionnaire (Hammond 1993)
Measured: 12 months post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Bryant, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675699
- Sponsor's protocol ID
- RG.AUHE.102510
- Acronym
- OFTEN
- Status last verified
- Jul 2019
- First submitted
- 28 Jan 2016
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Data IP is held with the HENRY organisation
Publications
Bryant M, Burton W, Collinson M, Farrin A, Nixon J, Stevens J, Roberts K, Foy R, Rutter H, Copsey B, Hartley S, Tubeuf S, Brown J. A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial. Trials. 2021 Nov 5;22(1):773. doi: 10.1186/s13063-021-05757-w.
PubMed 34740373Bryant M, Burton W, Cundill B, Farrin AJ, Nixon J, Stevens J, Roberts K, Foy R, Rutter H, Hartley S, Tubeuf S, Collinson M, Brown J. Effectiveness of an implementation optimisation intervention aimed at increasing parent engagement in HENRY, a childhood obesity prevention programme - the Optimising Family Engagement in HENRY (OFTEN) trial: study protocol for a randomised controlled trial. Trials. 2017 Jan 24;18(1):40. doi: 10.1186/s13063-016-1732-3.
PubMed 28115006
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Implementation Optimisation Intervention Aimed at Increasing Parent Engagement in HENRY, a Childhood Obesity Prevention Programme: a Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02675699
- Acronym / sponsor ID
- OFTEN / RG.AUHE.102510
- Conditions
- Childhood Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test whether parent engagement (recruitment, attendance) in a Childhood obesity prevention programme (HENRY) can be improved in local authorities randomised to receive an Optimisation intervention (in addition to standard HENRY) compared to those continuing to deliver the programme as standard.
Detailed description
BACKGROUND: Rising rates of obesity in preschool children are alarming and emphasise the need for evidence-based approaches to prevent obesity, which can be successfully implemented in communities. Although robust, theory-based prevention programmes exist, it is often a challenge to get parents to attend them and adopt positive behaviour changes in their families.
AIM: To evaluate the effectiveness of a recently developed 'Optimisation intervention' to optimise parent engagement in a community based obesity prevention programme 'HENRY', using routinely collected process data from existing sites commissioned to deliver HENRY in the UK
DESIGN: Multi-centre, cluster randomised controlled trial. As research will judge the ability of local authorities and their Centres to optimise implementation of HENRY, a cluster randomised design, has been chosen with local authority as the unit of randomisation. Local authorities will be randomised in a 1:1 allocation ratio (HENRY+ Optimisation Intervention; HENRY alone control) by a statistician at Leeds CTRU, using minimisation algorithm with random element, stratifying on baseline level of implementation (proportion of Centres meeting none of the 2 primary outcome implementation criteria/ meeting 1 or 2 of the criteria)) size of local authorities (number of Children's Centres (< 10/ ≥10)) and area deprivation (≤10% />10% ranking within Index of Multiple Deprivation at the Lower Layer Super Output Area).
Consent to participate will be sought at the cluster level (local authorities) and from the Centres within each local authority using an opt-out approach.
CONTROL ARM: HENRY delivered as standard. HENRY (Health, Exercise, Nutrition for the Really Young) is an 8-week programme delivered in Children's Centres (CCs), aiming to provide parents with skills and knowledge to support healthy lifestyles in preschool children and their families. It was set up in 2006 with Department of Health support aimed at reversing rising trends in school entry age obesity. HENRY is currently delivered in 32 local areas across England and Wales by trained health and community practitioners.
ACTIVE ARM: HENRY as standard plus an optimisation intervention to enhance parent engagement (recruitment and attendance) in the 8 week programme. A tailored 'Optimisation' intervention has been developed with a NIHR funds (CDF 2014-07-052) to support local authorities and Children's Centres to promote HENRY implementation, based on observations of positive deviants, interviews with Children Centre staff and other stakeholders, and input from parents. The resulting optimisation package is a multi-component intervention implemented at multi-levels (local authorities, Centres, parents). Precise details can not currently be disclosed to do risk of contamination.
ANALYSIS: Primary outcome analysis will be on the intention-to treat Population using a 3-level hierarchical model, with courses (or participants) nested within CCs within LA, adjusting for randomization minimisation variables. Differences in parent engagement, corresponding 95% CI, p-values and ICCs will be reported.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimisation + HENRY | Experimental | Behavioral: Optimisation + HENRY |
| HENRY as standard | Active comparator | Behavioral: HENRY as standard |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Local authorities providing data from at least 4 Children's Centres
- Courses delivered by trained staff who have been certified by HENRY
- At least one course to be delivered per Centre per year
- Sites with a history of providing process data for the previous year.
- There will be no exclusions based on the demographics of Children's Centres, but location will be monitored to ensure inclusion of those with diverse social and environmental characteristics.
Key exclusion criteria (5 listed)
- Areas which have plans to decommission the HENRY intervention during the course of the trial; or who are not planning on running HENRY programmes during the trial period.
- Centres where ethnography has taken place during Study 2
- Centres who are not planning on running HENRY programmes during the trial period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimisation + HENRYHENRY HENRY is an 8-week childhood obesity prevention programme delivered in Children's Centres in the UK by trained practitioners, aiming to provide parents with skills and knowledge to support healthy lifestyles in preschool children and their families. The programme aims to build parents' skills, knowledge and confidence to change old habits and provide healthier nutrition. OPTIMISATION A tailored 'Optimisation' intervention has being developed to support local authorities and Children's Centres to promote HENRY implementation, based on an ethnography of Children Centres, including interviews with staff and other stakeholders and input from parents. Development was underpinned by strong theories of behaviour change and will be guided by the intervention planning framework; the Behaviour Change wheel using a systematic approach. Strategies have been developed to improve parent motivation to enrol on to HENRY and promote parent self-efficacy to continue to attend. | Behavioural | Optimisation + HENRY |
| HENRY as standardLocal Authorities / Children's Centres that are assigned to the control group will continue with standard HENRY practice. Current HENRY QA practice involves the review of process data by HENRY central office with provision of written and oral feedback. This will continue in both trial arms and will be monitored. | Behavioural | HENRY as standard |
Primary outcome
Number of parents engaging with the HENRY programme measured using Centre level process data
Time frame: 12 month post randomisation (allowing 3 months for Optimisation intervention implementation and collecting data from 1- 2 HENRY courses per site).
Centre level data: A combined outcome of parent engagement based on the number of parents recruited per course and the attendance rate. In order to be effective, courses need improve parent engagement and retain parents to continue on the course.
5 secondary outcomes
Level of parent compliance to HENRY content measured via self-reported changes in frequency that fruits and vegetables are consumed each day by infants
Time frame: 12 months post randomisation
Parenting self-efficacy
Time frame: 12 months post randomisation
Eating behaviours
Time frame: 12 months post randomisation
Family activity
Time frame: 12 months post randomisation
Daily intake of key indicator foods in infants
Time frame: 12 months post randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Results publication: PubMed 34740373Bryant M, Burton W, Collinson M, Farrin A, Nixon J, Stevens J, Roberts K, Foy R, Rutter H, Copsey B, Hartley S, Tubeuf S, Brown J. A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial. Trials. 2021 Nov 5;22(1):773. doi: 10.1186/s13063-021-05757-w.
- Derived from this study: PubMed 28115006Bryant M, Burton W, Cundill B, Farrin AJ, Nixon J, Stevens J, Roberts K, Foy R, Rutter H, Hartley S, Tubeuf S, Collinson M, Brown J. Effectiveness of an implementation optimisation intervention aimed at increasing parent engagement in HENRY, a childhood obesity prevention programme - the Optimising Family Engagement in HENRY (OFTEN) trial: study protocol for a randomised controlled trial. Trials. 2017 Jan 24;18(1):40. doi: 10.1186/s13063-016-1732-3.
- Individual participant dataSharing planned: Undecided. Data IP is held with the HENRY organisation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Optimisation + HENRY and HENRY as standard in people with Childhood Obesity, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of parents engaging with the HENRY programme measured using Centre level process data (time frame: 12 month post randomisation (allowing 3 months for Optimisation intervention implementation and collecting data from 1- 2 HENRY courses per site).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02675699, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.