- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07478068
Can Personalised Digital Feedback Help Increase Plant Food Intake? (D4M)
Supporting Increased Plant Food Intake Using Personalised Digital Feedback
Inadequate plant food intake is a leading modifiable risk factor for non-communicable disease. However, on average, 88% of individuals do not consume adequate amounts of vegetables. Using digital technology may help improve health behaviours , with this potentially providing an accessible route to increasing plant food intake. However, uptake and engagement with applications designed to influence health behaviours is generally poor , and few studies have examined the main factors supporting user engagement and retention. Personalised dietary feedback, such as the provision of personalised advice or recipes, has the potential to enhance this process. However, whether nutritional interventions utilising personalised dietary feedback support user interaction, engagement, and retention remains to be studied.
Hence, the proposed project is a proof-of-concept study aiming to assess the effectiveness of using an application with personalised dietary feedback to support increased healthy plant food intake. 315 healthy males and females, between the ages of 18- and 45-years who self-report less than 50% of the recommended intake of vegetable consumption will participate in the study.
Before the intervention, participants will receive web-based instruction on the use of the smartphone application. Subsequently, participants will log all meals for two-weeks using the application to generate a baseline plant food consumption profile. In the baseline period, participants will wear a continuous glucose monitor. This will inform their individualised goals and possible feedback for the intervention period. The intervention will be 4-weeks in duration, consisting of the use of a personalised dietary program application, which will provide both recipes and feedback. Those randomised to the control will only have access to the meal logging feature. Throughout this period, participants will wear a smartwatch to track sleep metrics such as sleep onset and duration. Following the four-week intervention period, participants will be able to continue using the app for a six-week period, during which engagement with the application over time will be ascertained via telemetry. At the end of the follow-up, participants will receive an exit questionnaire to provide insight on their experience with the application, attitudes, habits and knowledge regarding consumption of plant foods, and self-perceived impact on health and dietary habits.
To provide mechanistic insight, a subset of participants (n = 50) will visit the laboratory at the University of Bath on two occasions (approximately 45 minutes each) - baseline and post-intervention. During laboratory visits, participants will provide blood pressure and body weight measurements, as well as saliva and venous blood samples. Saliva samples will be assessed for salivary cortisol, and blood samples will be assessed for the following: plasma glucose & insulin; plasma uric acid; plasma ascorbic acid; plasma tocopherols; serum carotenoids; plasma cytokines; plasma CRP and ferritin; F2-Isoprostanes; immune cell inflammatory capacity; HbA1c.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Somerset
-
Bath, Somerset, United Kingdom, BA2 7AY
- Recruiting
- Univeristy of Bath
-
Contact:
- Max Davis
- Phone Number: 01225 388388
- Email: md959@bath.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy males and females, age at start of the study ≥ 18 and ≤ 45 years;
- Non-rejectors of Knorr (due to the recipes in the PDP application);
- Currently cooking or intending to cook (*themselves or partner) at least one main meal at home for at least five days a week;
- Indicated desire to eat more vegetables;
- In possession of an Android or iOS-based smartphone;
- Willing to use an app to receive information and log all meals daily;
- Currently using or willing to use a smartwatch;
- Able to provide informed consent.
Exclusion Criteria:
- High reported baseline veg intake (participants need to self-report less than 50% of the UK rec / self-reported intake above the UK adult average (206 g/2.6 servings));
- Reported participation in another nutritional or biomedical trial within 1 month before the screening or during the study;
- Planned frequent travel (>2/month) and travel to countries with time zone >GMT +04:00 during the study period;
- Habitual consumption of >14 units (female participants) and >21 units (male participants) alcoholic drinks in a typical week;
- Reported start or change in use of any nicotine containing products directly preceding the study or during the study itself;
- If female, is pregnant (or has been pregnant during the last <3 months) or will be planning pregnancy during the study period;
- If female, is lactating or has been lactating in the 6 weeks before screening and/or during the study period;
- Reported dietary habits: medically prescribed diet, slimming diet, any condition or self-prescribed diet that restricts consumption of vegetables, not used to eating at least 3 meals a day;
- Reported body mass loss/gain (>5%) in the last 3 months before the study. Self-reported history of major depressive disorders and/or current use antidepressive/antianxiety medication;
- Clinically diagnosed sleep disorders and/or use prescribed sleep medication. Taking medication (including traditional medicines and or dietary supplements) which may pose undue personal risk or introduce bias into study measurements, as judged by the PI;
- An allergy to adhesives, which would prevent proper attachment of the CGM;
- Being an employee of any company developing personalised diet applications, including Salus Optima or Unilever.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Personalised Feedback
Participants allocated to the "Personalised Feedback" condition will receive personalised dietary feedback such as the provision of personalised advice or recipes
|
Personalised dietary feedback, such as the provision of personalised advice or recipes
|
|
Placebo Comparator: Control
Participants allocated to the "Control" arm will only use the application to log dietary intake and will receive no feedback or personalised advice.
|
Will only use the application to log meal and will receive no feedback or advice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plant Food Intake
Time Frame: Change from baseline
|
Daily consumption of plant foods measured in grams per day and servings per day
|
Change from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attitudes, Habits, and Knowledge
Time Frame: Change from baseline
|
Attitudes, habits, and knowledge regarding plant food cooking and intake measured via questionnaires (Health and Taste Attitude Scales, Roinine et al., 2001)
|
Change from baseline
|
|
Mood
Time Frame: Change from baseline
|
Negative and positive mood, vitality, flourishing and flourishing behaviours measured via questionnaires (Connor et al., 2017)
|
Change from baseline
|
|
Stress
Time Frame: Change from baseline
|
Perceived stress measured via the Perceived Stress Scale questionnaire
|
Change from baseline
|
|
Sleep
Time Frame: Change from baseline
|
Sleep quality measured via Pittsburgh Sleep Quality Index.
Sleep onset, wake after sleep onset, morning wake time, and total sleep time derived from smartwatch data
|
Change from baseline
|
|
Interstitial Glucose Concentration
Time Frame: Change from baseline
|
Interstitial glucose concentration measured every minute using a continuous glucose monitor
|
Change from baseline
|
|
Salivary Cortisol
Time Frame: Change from baseline
|
Salivary cortisol will be assessed upon waking using a biosynthetic swab in the mechanistic subset of participants
|
Change from baseline
|
|
Blood Lipids
Time Frame: Change from baseline
|
Blood lipids in the mechanistic subset will be analysed using an automated analyser (Daytona; Randox Lab, Crumlin, UK).
Samples will be obtained following an overnight fast
|
Change from baseline
|
|
Plasma Glucose
Time Frame: Change from baseline
|
Plasma glucose in the mechanistic subset will be analysed using an automated analyser (Daytona; Randox Lab, Crumlin, UK).
Samples will be obtained following an overnight fast
|
Change from baseline
|
|
Plasma Uric Acid
Time Frame: Change from baseline
|
Plasma uric acid in the mechanistic subset will be analysed using an automated analyser (Daytona; Randox Lab, Crumlin, UK).
Samples will be obtained following an overnight fast
|
Change from baseline
|
|
Plasma Insulin
Time Frame: Change from baseline
|
Plasma insulin in the mechanistic subset will be ascertained using commercially available enzyme-linked immunosorbent assays (ELISA).
Samples will be obtained following an overnight fast
|
Change from baseline
|
|
Serum Carotenoids
Time Frame: Change from baseline
|
Serum carotenoids in the mechanistic subset will be quantified using high-performance liquid chromatography.
Samples will be collected following an overnight fast
|
Change from baseline
|
|
Plasma Cytokines
Time Frame: Change from baseline
|
Plasma cytokines (adiponectin, IL-6, IL-10) in the mechanistic subset will be ascertained via ELISA.
Samples will be collected following an overnight fast
|
Change from baseline
|
|
Immune Cell Activation
Time Frame: Change from baseline
|
Immune cell activation in the mechanistic subset will be assessed using whole blood stimulation.
Samples will be collected following an overnight fast
|
Change from baseline
|
|
Plasm C-reactive Protein
Time Frame: Change from baseline
|
Plasma C-reactive Protein in the mechanistic subset will be quantified using ELISA.
Samples will be collected following an overnight fast
|
Change from baseline
|
|
Plasma Ferritin
Time Frame: Change from baseline
|
Plasma ferritin in the mechanistic subset will be quantified via ELISA.
Samples will be collected following an overnight fast
|
Change from baseline
|
|
Attitudes, Habits, and Knowledge
Time Frame: Change from baseline
|
Attitudes, habits, and knowledge regarding plant food cooking and intake measured via questionnaires (Food Neophobia Scale, Pliner & Hobden, 1992)
|
Change from baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 8028-11785
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Plant Food Intake
-
Pennington Biomedical Research CenterCompletedFood Intake | Energy Intake | Dietary Assessment | Food PhotographyUnited States
-
Clinical Nutrition Research Centre, SingaporeCompletedMarkedly Reduced Food Intake | Satiety and Food IntakeSingapore
-
University of ReadingImperial College London; University of Cambridge; Aberystwyth UniversityRecruitingDietary Intake Assessment | Food Intake MeasurementUnited Kingdom
-
Stanford UniversityCompletedAvoidant / Restrictive Food Intake Disorder
-
Joseph Brant HospitalWestern UniversityRecruiting
-
Massachusetts General HospitalAmerican Psychological Foundation; The Hilda & Preston Davis FoundationCompletedAvoidant/Restrictive Food Intake Disorder (ARFID)United States
-
Tilburg UniversityCompleted
-
Pennington Biomedical Research CenterCompellis PharmaceuticalsTerminated
-
Oxford Brookes UniversityCompleted
-
Claudine MANACHNational Research Agency, FranceCompletedBiomarkers | Food IntakeFrance
Clinical Trials on Personalised Feedback
-
King's College LondonCompleted
-
The University of Hong KongCompletedWomen at Risk of Common Mental DisordersHong Kong
-
Imperial College LondonActive, not recruitingFrailty | Feasibility Studies | Older Adults (65 Years and Older) | Digital Health InterventionUnited Kingdom
-
Rennes University HospitalActive, not recruiting
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloRecruiting
-
University of ReadingCompletedDietary Habits | Dietary ModificationUnited Kingdom
-
University of Southern DenmarkNational Board of Health, DenmarkCompleted
-
University of ReadingCompletedDietary Habits | Dietary ModificationKuwait, United Kingdom
-
St Mary's University CollegeUnknown
-
The University of Hong KongChinese University of Hong KongRecruiting