- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06833736
A Health App Using Recipes and Education Components to Facilitate Sustainable and Healthier Diets.
Feasibility and Acceptability of a Digital Health App to Facilitate More Sustainable and Healthier Diets: Protocol for a Pilot Trial.
This study is a pilot trial of a smartphone app to promote sustainable and healthy eating, running for 10 weeks. The app aims to promote general wellbeing in the working population. The investigators are interested in the feasibility and acceptability of the plant-based recipes and information pages, so the focus will be on how people engage with these features and how they meet their needs.
Participants will be randomised into three groups:
- General information (no app).
- Standard app (app as it stands).
- Enhanced app with recipes and behaviour change recommendations (app + messages).
Data on demographics and food choice will be collected at the start and end of the intervention. A subset of participants will also take part in short interviews to talk about their experiences.
Study Overview
Status
Intervention / Treatment
Detailed Description
Overall aim:
This pilot trial aims to understand the feasibility and acceptability of a health and wellbeing app. The main focus is around the plant-based recipes and information pages delivered through the chat functionality.
Specific objectives:
The primary objective is to understand the feasibility and acceptability of setting up and running a trial with the app, focusing on the reach, adoption, implementation, and maintenance. The secondary objectives are to explore the indicative efficacy of the app in facilitating more sustainable and healthier diets, measured by a change in meat and legume intake, to what extent the recipes and information pages contribute to this effect, and whether there is a relationship between the self-perceived capabilities, opportunities and motivations to consume a sustainable and healthier diet.
Intervention:
The overall aim of the app is to enhance general wellbeing. The information pages contain general information on certain aspects of diets for health and sustainability. The recipes are available for breakfast, lunch and dinner, and vary in their composition of healthy and sustainable foods.
Sample size:
The target sample size will be 99 (33 per arm), which will account for the possibility of 40% dropout in the first two weeks, which is typical for smartphone apps, and would still suffice the rule of thumb for 25 per group to be included in a pilot study to yield a small standardised effect size.
Outcomes:
Outcomes (and data) that will be collected and include 1) programme reach (population characteristics), 2) adoption of the app (participation and retention rates), 3) acceptability of the intervention (engagement with and usefulness of the app features), 4) implementation of delivering the intervention (compliance), 5) maintenance of the intervention (participant and organizational sustainability), and 6) efficacy of the intervention (indications of change in behavioural determinants and behaviours).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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London, United Kingdom
- London School of Hygiene & Tropical Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Have a personal (not work) smartphone
- Have access to WiFi at home
- Have an out-of-home data package
- Be 18 years of age or older
Exclusion Criteria:
- Underweight for their age and gender
- Follow a restrictive diet (e.g., pregnant, breastfeeding, food intolerant/allergic, attempting to lose weight, diabetes, cardiovascular disease, or other long-term disease including eating disorders)
- Have a mental disability or learning difficulty
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 |
|---|---|
|
Active Comparator: Control group
|
The (no app) control group will be sent general health and sustainability information via email immediately after randomisation is done.
To incentivise participation in both baseline and follow-up assessments, the control group will be offered lifetime access to the app and a summary of their self-reported food intake at week 10.
The control group will be sent one email reminder halfway through (week 5) to remind them that they are involved in the study, provide them with instructions on the follow-up assessment, and that they will receive the intervention and dietary feedback at week 10.
|
|
Experimental: Intervention group 1
|
As the app has not been evaluated before in terms of its impact on dietary change, the first intervention group will have the app as it stands.
The overall aim of the app is to improve general wellbeing across several health-related domains, which is achieved through engaging with its main features (the daily plan, journal, user profile, and chat function).
|
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Experimental: Intervention group 2
|
The plant-forward recipes and information pages available on the app will be made more salient for app users in this group through sending them via targeted messages in the chat function at specific times.
Each day, the information pages will be sent at 09:30 and the recipes will be sent at 13:00.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to intervention
Time Frame: From enrolment to the end of the intervention at 8 weeks
|
Number of days participants log on to the app, measured using the app analytics
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From enrolment to the end of the intervention at 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in legume intake
Time Frame: Enrolment and at the end of the intervention at 8 weeks
|
Self-reported dietary intake from two 24h dietary recalls, averaged into portions per day
|
Enrolment and at the end of the intervention at 8 weeks
|
|
Change in meat intake
Time Frame: Enrolment and at the end of the intervention at 8 weeks
|
Self-reported dietary intake from two 24h dietary recalls, averaged into portions per day
|
Enrolment and at the end of the intervention at 8 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Other Study ID Numbers
- 28317
- 204000 (Other Grant/Funding Number: NIHR)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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