ISRCTN ISRCTN10470937
DOI https://doi.org/10.1186/ISRCTN10470937
Secondary identifying numbers 5766/003
Submission date
25/02/2019
Registration date
08/03/2019
Last edited
16/03/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims:
TOP TIPS is a simple and effective weight loss approach which was converted into an Android app. The study tested two versions of TOP TIPS that were accessed through participants' smartphone. The apps aimed to help people develop healthy habits and lose weight.

Who can participate:
To be eligible to take part in this research people had to: be 18 years or over; speak English fluently; live in the UK; have Body Mass Index 25kg/m2 or over and own an android smartphone.

What does the study involve:
Taking part in the study involved using the TOP TIPS weight loss app for 3 months. Some participants were able to start straight away while others were asked to wait for three months to get access to the app. Taking part required no more than 10 minutes per day of participants' time, and they could use the app a time that suits them. The Top Tips apps advised users to make context-specific plans to turn each tip into a habit and adjust these whenever needed. The app also asked users to track their weight in kg and adherence to the tips each day. The apps provided automatic updates of how many times each tip was achieved per week, as well as daily reminders to promote engagement with the app.

What are the possible benefits and risks of participating:
Potential benefits included weight loss and improvements in participants' diet and activity behaviours. No risk was foreseen from taking part in this research.

Where is the study run from:
The intervention was run entirely online.

When is the study starting and how long is it expected to run for?
The study started in January 2017 and was expected to run for 3 months.

Who is funding the study:
The app development was partially funded by the charity Weight Concern and partially funded by White October, a web design and development company. Researchers involved in this study were supported by CRUK, YCR, and CAPES/Brazil.

Who is the main contact:
For more information about the study, please e-mail Nathalie.kliemann.13@ucl.ac.uk or access the study website: http://weightconcern.wixsite.com/toptips

Study website

Contact information

Dr Rebecca Beeken
Scientific

Leeds Institute of Health Sciences
Level 10, Worsley Building
Clarendon Way
Leeds
LS2 9NL
United Kingdom

ORCiD logoORCID ID 0000-0001-8287-9351
Phone +44 (0)113 343 3228
Email r.beeken@leeds.ac.uk

Study information

Study designMixed methods pilot study
Primary study designInterventional
Secondary study designThree-arm, individually-randomised, controlled pilot study
Study setting(s)Internet/virtual
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleDevelopment of the Top Tips habit-based weight loss app and preliminary indications of its usage, effectiveness and acceptability: a mixed methods pilot study
Study objectivesParticipants would engage with the apps and find them useful. Both Top Tips habit-based apps would promote greater eating self-regulatory skills, weight loss and healthy behaviours among adults with overweight or obesity compared to the control group. The 'Top Tips plus app' would promote greater absolute decreases in sweet snacks and sugar sweetened drinks intake compared to the 'Top Tips only app'.
Ethics approval(s)Approved 16/09/2016, UCL Research Ethics Committee (Research Ethics Co-ordinator, Office of the Vice-Provost (Research), University College London, 2 Taviton St, London, WC1E 6BT; 020 7679 8717; ethics@ucl.ac.uk), ref: 5766/003.
Health condition(s) or problem(s) studiedOverweight or obesity
InterventionParticipants were individually randomised to one of the three group conditions:
i) Top Tips ‘only’ app;
ii) Top Tips ‘plus’ app (including an additional tip on dealing with tempting foods) or
iii) no intervention control group (waiting list).
The active intervention period was 3 months and follow-up data were collected at the end of this period. Both the content and format of the Top Tips apps were developed based on:
i) the 10 Top Tips leaflet;
ii) the principles of Habit Theory;
iii) empirical evidence from the field of weight loss and behavioural nutrition and;
iv) the experience of the developers in designing health apps for behaviour change.
They were designed for android devices. The Top Tips apps advised users to make context specific plans to turn each tip into a habit and adjust these whenever needed. The app also asked users to track their weight in kg and adherence to the tips each day. The apps provided automatic updates of how many times each tip was achieved per week, as well as daily reminders to promote engagement with the app. A total of 9 notifications were designed related to different functions of the app,easy to add to past days. A random notification was sent each day in the evenings as it was anticipated that this would be the most likely time people would log their adherence to the target behaviours and review their plans. However, participants could turn this function off if they wanted.
The Top Tips ‘plus’ app included an additional tip targeting self-regulatory strategies to resist tempting food. This new tip was developed based on the current evidence for reducing unhealthy food cravings and avoiding lapses. The tip promoted visual imagery and distraction strategies to avoid cues that elicit urges to eat unhealthy foods, which may increase the likelihood of resisting tempting food. The additional tip also provided examples of forming coping plans using these strategies. In line with the other tips, users were required to make their own coping plans to resist unhealthy food and monitor their progress every day, assessing whether they experienced food cravings and whether they could resist them.
After randomisation, participants randomised to one of the 2 app groups received an email with instructions about the intervention and a passcode to access the app. Participants were instructed to use the app every day for 3 months, which is the period usually required to form habits. Participants randomised to the control condition received an email explaining that they had been allocated to the waiting list group and that they would receive access to the weight loss app in 3 months’ time. Prior to randomisation and at 3-month follow-up all participants were requested to complete an online questionnaire. To promote completion of the post-intervention assessment all participants had the chance to enter a draw to win one of three £20 high street vouchers. However, they were only informed about the prize draw at the end of the intervention, to ensure only participants who were motivated to lose weight and to improve their diet were recruited to the study. Participants from the Top Tips apps conditions were also invited to answer qualitative questions at the end of the online follow-up questionnaire to further explore their experience of using the apps.
The randomisation was performed by the principal investigator using Minimpy software. Randomisation was stratified by gender, age and BMI classification to prevent imbalances between the treatment groups that could influence the effect of the intervention.
Intervention typeBehavioural
Primary outcome measureUsage pattern and users’ feedback were the primary variables of interest. Automated data from Top Tips ‘only’ and Top Tips ‘plus’ users were collected over the 3-month intervention period to assess usage patterns (number of log-ins; pages viewed; plans made; total time spent on the app in minutes and the number of times weight was logged and each tip was achieved).

To assess acceptability of the Top Tips apps, eight open questions relating to users’ experience of using the apps were included in the online follow-up questionnaire at 3 months.
Secondary outcome measures1. Weight and height were self-reported using an online questionnaire at baseline and 3-month follow-up
2. Overall frequency of the target behaviours was measured online using a 16-item questionnaire (developed previously for the 10 Top Tips intervention on a 5-point Likert scale) at baseline and 3-month follow-up
3. Dietary intake was measured online using validated food frequency questionnaires (assessing fruit and vegetable; sweet snack and sugar-sweetened drinks intake on a 7-point Likert scale) at baseline and 3-month follow-up.
4. Fat intake was measured online using the dietary fat scale from the validated Dietary Instrument for Nutrition Education (DINE) at baseline and 3-month follow-up.
Overall study start date01/05/2015
Completion date01/03/2017

Eligibility

Participant type(s)Mixed
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants25 participants per randomisation group
Total final enrolment81
Key inclusion criteria1. Adults (18 years or over) from the UK
2. Owned an android smartphone
3. Read English fluently
4. Overweight or obese (BMI ≥ 25 kg/m2)
Key exclusion criteria1. Unable to provide informed consent
2. Pregnant or breastfeeding
3. Expecting to have bariatric surgery in the following 3 months or were recovering from bariatric surgery
4. On a strict weight loss treatment, such as meal replacements
Date of first enrolment01/01/2017
Date of final enrolment01/03/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Behavioural Science and Health
University College London
2nd and 3rd floor
1-19 Torrington Place
London
W1CE 7HB
United Kingdom

Sponsor information

Weight Concern
Charity

1-19 Torrington Pl
London
WC1E 7HB
United Kingdom

Phone 020 7679 1853
Email enquiries@weightconcern.org.uk
Website http://www.weightconcern.org.uk/
ROR logo "ROR" https://ror.org/04zhncz06
White October
Other

3 The Gallery
54 Marston Street
Oxford
OX4 1LF
United Kingdom

Phone +44 (0) 1865 920707
Email info@whiteoctober.co.uk
Website https://www.whiteoctober.co.uk/

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom
Yorkshire Cancer Research
Government organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
YCR
Location
United Kingdom
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
Government organisation / National government
Alternative name(s)
Brazilian Federal Agency for the Support and Evaluation of Graduate Education, Coordination for the Improvement of Higher Education Personnel, CAPES Foundation, Capes - Ministério da Educação, Coordinación de la formación del personal de nivel superior (Brasil), CAPES
Location
Brazil

Results and Publications

Intention to publish date01/02/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 10/05/2019 17/05/2019 Yes No

Editorial Notes

16/03/2020: Internal review.
17/05/2019: Publication reference and total final enrolment number added.
15/03/2019: Internal review.
27/02/2019: Trial’s existence confirmed by IRB.