Healthier Wealthier Families In East London: HWFinEL (HWFinEL)

March 6, 2025 updated by: University College, London

Healthier Wealthier Families in East London (HWFinEL): Evaluating and Extending Health and Wellbeing Benefits of Universal Co-located Money Advice for Parents of Newborns

The financial condition children live in when they are young can affect their health, not only in their childhood but also throughout their lives. The cost-of-living crisis means many families are 'going without' the basics. Many people do not claim all the benefits they are entitled to, or know how to solve money problems because they find it difficult to access advice. Parents with a new-born baby are especially likely to need financial support.

Research shows that after getting money advice services linked up with routine health services, family income can improve. The investigators don't yet know if linking up money advice with routine health appointments improves parents' health and wellbeing as well as their household income. The investigators don't know whether making these services easy to access through linking them up has long term implications for children's health and wellbeing. Finally, at the moment the investigators don't know how best health and money advice services can be organised to help mothers or fathers who are in difficulty such as those who are homeless or have recently arrived in England.

The goal of this trial is to improve low-income families' living conditions and ensure that all children have the best start in life. The investigators hypothesise a co-located approach will serve as a vital step toward a more integrated approach to health and social welfare, ultimately benefitting families in need. The investigators will be comparing one group of participants who will receive welfare benefits advice from a welfare benefits advisor (WBA) that is co-located with routine 6-8 week newborn health check appointments in a Children and Families Centre (CFC). The other group will receive standard care and be given information on where they can access welfare benefits advice.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The trial is evaluating the impact of co-located welfare benefits advice with Health Visiting appointments and the investigators will triangulate findings from the following aspects:

  • A randomised controlled trial assessing the impact of money advice services on parental mental health.
  • A process evaluation to assess how the intervention is implemented and how it impacts on users.
  • An economic evaluation to assess the cost-benefit of the intervention.

The overall project includes four integrated work packages (WP):

  • WP1 will include a process evaluation, explore service uptake and qualitative experiences of the service.
  • Findings from WP1 will be used in modelling to estimate the long-term multi-sector costs and benefits of the service (WP2).
  • The investigators will use qualitative methods to co-design a draft toolkit based on the experiences and participation of a marginalised group of mothers to inform service development (WP3).
  • Evidence arising from WPs1-3 will be actively disseminated locally, regionally and nationally, across a range of stakeholders, and via international networks, to maximise impact (WP4).

This is a randomised controlled trial whereby participants will be randomised in a 1:1 ratio to either the intervention group (welfare benefits advice (WBA) appointment) or the control group (existing service as usual).

The intervention will be WBA co-located with routine health appointments and delivered in Children and Families Centres (CFCs) in The London Borough (District) of Tower Hamlets. Over 98% of new babies are enrolled in the health visiting service. Co-located Welfare Benefits Advice with health appointments is an example of a Health Justice Partnership found to be an effective tool in addressing health equity.

The project will run over a period of 36 months. The target sample size is 1153 participants. The investigators will recruit over 16 months, with a 6 month internal pilot. Participants will be followed up for 6 months from the baseline time point (though could be in the trial for up to 9 months if they consent to take part in an interview (only a sub-group of participants)).

Study Type

Interventional

Enrollment (Estimated)

1153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Claire Cameron, D Phil - Social Intervention
  • Phone Number: 020 7612 6249
  • Email: c.cameron@ucl.ac.uk

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Mothers or fathers aged 16 years or over.*
  • Mothers or fathers with a live baby/babies less than three months old who are registered with the health visitor service in LBTH, at the point of consent, who respond Yes to a screening question asking if they wish to receive advice about money.**
  • Able to provide informed consent.
  • Able and willing to complete questionnaires.

Please note:

*Only one parent will be recruited. If one parent is under the age of 16, they will not be eligible.

**If the participant has multiple children, at least one child must be <3 months old.

Exclusion Criteria:

Mothers or fathers with:

  • Any known safeguarding concern.
  • Maternal or paternal diagnosis of learning difficulty that affects the capacity to consent.
  • A baby/babies who have significant medical complications (e.g., inpatient on a neonatal unit).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1. Intervention
Participants who are randomised to receive the intervention (Welfare Benefits Advice (WBA)) will be contacted by a UCL researcher and invited to attend a Welfare Benefits Advice appointment within 3 months of randomisation, to coincide with their new-born's 6-8 week health check.
Other: Welfare Benefits Advice (WBA)
Appointment offered to receive financial advice from a Welfare Benefits Advisor (WBA) co-located with routine 6-8 week newborn health checks
Other: Arm 2. Control
Participants who are randomised to the control group will be emailed or posted a card detailing the London Borough of Tower Hamlet's existing 'service as usual' Welfare Benefits Advice services, which reproduces what is available on their website.
Other: Usual care
No intervention, existing London Borough of Tower Hamlets 'service as usual'

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in depression scores at 6 months
Time Frame: Six months from baseline

Difference in depression (Patient Health Questionnaire Depression Scale-8 (PHQ-8)) scores at 6 months' follow-up in the intervention arm compared with the control arm accounting for baseline values and adjusted for stratification variables (if any). The outcome will be examined to ensure that it meets the assumptions for regression analyses and transformed, if necessary, to an appropriate scale so that the resultant distribution approaches normality.

The PHQ-8 is an 8-item instrument with a 4-item scale. Each item asks the individual to measure their depression symptoms over the past two weeks. Response options include 0 = not at all, to 3 = nearly every day. Higher scores mean a worse outcome.
Six months from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Financial gain at 6 months
Time Frame: Six months from baseline
Difference in household financial income at 6 months' follow-up in the intervention arm compared with the control arm accounting for baseline values and for stratification values (if any). The outcomes will be examined to ensure that it meets the assumptions for regression analyses and transformed, if necessary, to an appropriate scale so that the resultant distribution approached approaches normality.
Six months from baseline
Anxiety scores at 6 months
Time Frame: Six months from baseline
Difference in the General Anxiety Disorder-7 (GAD-7) scores at 6 months follow-up in the intervention arm compared with the control arm accounting for baseline values. The GAD-7 measure, is a 7-item instrument with a 4-item scale. Each item asks the individual to measure their anxiety symptoms over the past two weeks. Response options include 0 = not at all, to 3 = nearly every day. Higher scores mean a worse outcome.
Six months from baseline
Quality of Life at 6 months
Time Frame: Six months from baseline
Parental wellbeing: Difference in the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) scores at 6 months follow-up in the intervention arm compared with the control arm accounting for baseline values. The SWEMWBS is a 7-item scale with five response options. Each item asks the individual to measure their mental wellbeing over the past two weeks. Response options include 1 = none of the time, to 5 = all of the time. Higher scores mean a worse outcome.
Six months from baseline
Quality of life (economic evaluation) at 6 months
Time Frame: Six months from baseline
Difference in EuroQol-5 Dimension 5-level (EQ-5D-5L) scores at 6 months follow-up in the intervention arm compared with the control arm accounting for baseline values. It comprises of 5 dimensions of health (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with 5 levels of severity in each dimension (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems). Higher scores mean a worse outcome.
Six months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CCTU/2023/464
  • NIHR158551 (Other Grant/Funding Number: National Institute for Health and Care Research (NIHR))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The sharing of individual participant data is not planned outside of the direct research team (or healthcare professionals who will be seeing the participant).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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