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Comparing Approaches to Increasing Fruit and Vegetable Intake and Their Influence on Metabolic Health

C

Courtney Neal

Status

Completed

Conditions

Metabolic Health
Fruit and Vegetable Intake

Treatments

Behavioral: Educational information (Increasing F&V intake)
Behavioral: Educational information (Increasing F&V intake + Juice)
Behavioral: Educational information (Control)

Study type

Interventional

Funder types

Other

Identifiers

NCT06628401
2792/48171
NU-019324 (Other Grant/Funding Number)

Details and patient eligibility

About

This experimental study aims to evaluate the effects of different strategies for increasing fruit and vegetable intake and to see how these interventions influence markers of health in people aged 18-65 who currently consume fewer than 2 portions of fruit and vegetables a day.

The main questions it aims to answer are:

  1. How does 5-a-day advice, with and without the inclusion of fruit juice, impact fruit and vegetable intake over a four-week period?
  2. What are the acceptability and perceived ease of increasing fruit and vegetable intake with and without the inclusion of fruit juice in 5-a-day recommendations?
  3. What are the effects of increasing fruit and vegetable intake with and without fruit juice on markers of metabolic health?

Researchers will answer these questions by comparing results from three groups of participants. All participants will provide a pre- and post-intervention blood sample, complete various questionnaires, and follow a four-week intervention that comprises educational material and a weekly £10 voucher. Over the course of the four weeks, they will report what they ate in a day on four different days.

The groups differ in the educational materials provided and where they can spend their voucher:

  • Group 1 (Control) - information on the importance of including an experimental control in research and a weekly voucher to spend at a retailer of their choice,
  • Group 2 (F&V) - information on 5-a-day advice (excluding fruit juice) and a weekly voucher to spend in a supermarket on F&V, and
  • Group 3 (F&V + Juice) - information on 5-a-day advice (including fruit juice) and a weekly voucher to spend in a supermarket on F&V.

Enrollment

42 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Aged 18 - 65 years
  • Currently consuming ≤2 portions of fruit and vegetables per day

Exclusion criteria

  • Using high-dose vitamins, minerals or dietary supplements that could interfere with biomarker assessment of fruit and vegetable consumption
  • Have a food sensitivity, allergy or other dietary restriction (e.g., following a weight loss diet) that would limit the ability to take part in the study
  • Have a medical condition (e.g., diabetes or gastrointestinal disorders) that would limit the ability to take part in the study
  • Currently pregnant or lactating

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

42 participants in 3 patient groups, including a placebo group

Group 1 (Control)
Placebo Comparator group
Description:
Participants will be asked to maintain their habitual diet throughout the intervention. They will be provided with a brief document outlining the importance of a control group in research studies to maximise compliance. They will also receive £10/week vouchers during the intervention period and a further £60 on completion of the study to replicate voucher provision in the two intervention groups. Mimicking the voucher provision structure of the intervention groups will help to minimise participant drop out and will avoid any bias associated with differential financial remuneration between groups.
Treatment:
Behavioral: Educational information (Control)
Group 2 (Whole F&V)
Active Comparator group
Description:
Participants will be provided with educational material to increase their fruit and vegetable intake to meet 5-a-day guidelines via exclusive intake of whole fruits/vegetables . They will receive £10/week supermarket vouchers during the intervention period to support fruit/vegetable purchase. They will receive a further £60 on completion of the study.
Treatment:
Behavioral: Educational information (Increasing F&V intake)
Group 3 (Whole F&V + Juice)
Experimental group
Description:
Participants will be provided with educational material to increase fruit and vegetable intake to meet 5-a-day guidelines, with recommendations to consume one portion per day via fruit juice/smoothies. Participants will receive the same financial support as group 2.
Treatment:
Behavioral: Educational information (Increasing F&V intake + Juice)

Trial contacts and locations

1

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Central trial contact

Courtney Neal

Data sourced from clinicaltrials.gov

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