Plain English Summary
Background and study aims
Obesity is a key economic and healthcare challenge for Europe. Most adults try to lose weight but fail to maintain it. Effective programmes for weight loss are widely available, but most people re-gain their lost weight. The most promising behaviour change techniques for maintaining weight loss maintenance are self-monitoring, goal setting, action control, building self-efficacy and intrinsic motivation. Stress management and emotion regulation skills can also prevent relapse and weight regain. Information communication technology (ICT) offers attractive tools for teaching and supporting these techniques, some of which are currently delivered face-to-face. ICT delivery includes tracking technologies, weighing scales and activity sensors, online tools and smartphone apps, multimedia resources and internet-based support. A broad choice of tools is most likely to be acceptable to users, who can pick and choose their own preferred technologies. This study tests whether ICT-based delivery of the most promising behavior change techniques is effective for maintaining weight loss.
Who can participate?
Adults aged 18 or older who have lost at least 5% of their body weight intentionally in the last 12 months, and started with a BMI of 25 or more
What does the study involve?
Participants are invited to attend five sessions across 18 months. Additionally, at a number of time points (month 1, 3, 6, 12 and 18) throughout the study, participants are also asked to complete some short online questionnaires about their experience of the toolkit.
The first visit takes place at the research centre at the University of Leeds and takes up to 4 hours. Participants are asked to give a range of measurements including body weight, height, hip and waist circumference, and health markers including optional blood pressure, body composition, and optional hair samples. Participants also have the option to provide fasting blood samples via a small finger-prick, which will help to assess important health markers but this is voluntary. Participants are also asked to fill out a one-off questionnaire. This includes information such as date of birth, gender, and personal characteristics (e.g. weight loss history, experience with mobile technologies, and some questions about your typical eating behaviour). Participants are also asked to complete questionnaires relating to physical activity, motivation, emotional state, stress, well-being, quality of life, and diet. Participants are then randomly allocated to one of four groups. These groups are offered one of four different versions of the toolkit that might provide general health information, tools to help participants self-manage their eating and activity behaviours, their motivation, or their emotional responses to stress. Participants in each of these groups are required to weigh themselves a minimum of twice a week and on the same days of the week (e.g., Monday and Thursday) throughout the study with the Fitbit Aria weighing scales. Participants are also required to wear a wrist-worn activity meter (Fitbit Charge 2) for the duration of the study. Participants are provided with these devices free of charge. At the end of the day, there is a short training session to get participants set up with their tools (Fitbit Charge 2 and Aria weighing scales). A few days after their visit participants are also asked to complete an online 4-day food diary. Participants are then asked to visit the University of Leeds one week later for a shorter second visit (2 hours) for training on how to use the different components of the Toolkit (i.e. the NoHoW web-based app, the Fitbit Charge 2 and Aria scales). The third, fourth and fifth visits take place at 6, 12 and 18 months after the first visit and last up to 4 hours each. A researcher takes many of the same measurements made at visit 1 including body weight, height, hip and waist circumference, blood pressure and body composition. Participants are asked to complete questionnaires relating to physical activity, motivation, emotional state, stress, well-being, quality of life, and diet.
What are the possible benefits and risks of participating?
The potential benefits are increased knowledge and skills for weight loss maintenance in the long-term. Participants receive a £30 reward and are able to keep the Fitbit Charge HR and Aria scales for free. There are no expected disadvantages involved in taking part in this study.
Where is the study run from?
1. University of Leeds (UK)
2. The Parker Institute (Denmark)
3. University of Lisbon (Portugal)
When is the study starting and how long is it expected to run for?
March 2015 to February 2020
Who is funding the study?
European Union’s Horizon 2020 research and innovation programme (Belgium)
Who is the main contact?
Prof. James Stubbs
r.j.stubbs@leeds.ac.uk
Study website
Contact information
Type
Scientific
Contact name
Prof James Stubbs
ORCID ID
http://orcid.org/0000-0002-0843-9064
Contact details
School of Psychology
Faculty of Medicine and Health
University of Leeds
Leeds
LS2 9JT
United Kingdom
+44 (0)113 343 3476
r.j.stubbs@leeds.ac.uk
Type
Public
Contact name
Dr Sarah Scott
ORCID ID
Contact details
School of Psychology
Faculty of Medicine and Health
University of Leeds
Leeds
LS2 9JT
United Kingdom
+44 (0)113 343 3476
s.e.scott@leeds.ac.uk
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
A 2 x 2 randomised controlled trial to evaluate the effectiveness of evidence-based information and communications technology behaviour change tools for weight loss maintenance in overweight/obese adults after clinically significant weight loss
Acronym
NoHoW
Study hypothesis
1. That participants will be more effective at maintaining weight loss in the long-term when receiving a toolkit that combines content for self-regulation and motivation compared to only self weighing.
2. That participants will be more effective at maintaining weight loss in the long-term when receiving a toolkit that combines content emotion-regulation components compared to only self weighing.
3. That there is an additive effect of combining self-regulation and emotion regulation at improving maintenance of weight loss compared to only self weighing.
Ethics approval(s)
The University of Leeds, School of Psychology Research Ethics Committee, 27/10/2016, ref: 16-0275
Study design
International multi-centre 2 x 2 four-arm randomised controlled trial with adaptive stratified sampling using minimisation
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Community
Study type
Prevention
Patient information sheet
Participant information sheet can be found on the recruitment website at http://uk.nohow.eu
Condition
Overweight and obese adults who have achieved clinically significant weight loss (5%)
Intervention
The NoHoW study is an International multi-centre 2 x 2 four-arm randomised controlled trial with adaptive stratified sampling using minimisation. It will run across 18 months, which will include a 6-month active intervention and a 12-month follow up.
Participants attend five sessions across 18 months. Additionally, at a number of time points (month 1, 3, 6, 12 and 18) throughout the study, participants are also asked to complete online questionnaires about their experience of the toolkit.
The first visit takes place at the research centre at the University of Leeds and takes up to 4 hours. Participants are able to discuss the study in detail and are invited to sign a consent form giving your agreement to participate in the study. All data will be anonymised. Participants are then asked to give a range of measurements including body weight, height, hip and waist circumference, and health markers including optional blood pressure, body composition, and optional hair samples. Participants also have the option to provide fasting bloods samples via a small finger-prick, which will help to assess important health markers but this is voluntary. Participants are also asked to fill out a one off questionnaire. This includes information such as date of birth, gender, and personal characteristics (e.g. weight loss history, experience with mobile technologies, and some questions about your typical eating behaviour). Participants are also asked to complete questionnaires relating to physical activity, motivation, emotional state, stress, well-being, quality of life, and diet.
Participants are then randomly allocated to one of four groups. These groups are offered different versions of the toolkit that might provide general health information, tools to help participants self-manage their eating and activity behaviours, their motivation, or their emotional responses to stress. The four groups are:
1. Self-weighing, only access to generic toolkit content
2. Self-weighing and toolkit content focused on self-regulation and motivation components, including feedback on weight trajectories
3. Self-weighing and toolkit content focused on emotional regulation, including feedback on weight trajectories
4. Self-weighing and toolkit expanded to focus on both self-regulation + motivation + emotional components, including feedback on weight trajectories
Participants in each of these groups are required to weigh themselves a minimum of twice a week and on the same days of the week (e.g., Monday and Thursday) throughout the study with the Fitbit Aria weighing scales. Participants are also required to wear a wrist-worn activity meter (Fitbit Charge 2) for the duration of the study. Participants are provided with these devices free of charge. At the end of the day, there is a short training session to get participants set up with their tools (Fitbit Charge 2 and Aria weighing scales). A few days after their visit participants are also asked to complete an online 4-day food diary.
Participants are then asked to visit the University of Leeds one week later for a shorter second visit (2 hours) for training on how to use the different components of the Toolkit (i.e. the NoHoW web-based app, the Fitbit Charge 2 and Aria scales).
The third, fourth and fifth visits take place at 6, 12 and 18 months after the first visit and last up to 4 hours each. A researcher takes many of the same measurements made at visit 1 including body weight, height, hip and waist circumference, blood pressure and body composition. Participants are asked to complete questionnaires relating to physical activity, motivation, emotional state, stress, well-being, quality of life, and dietary intake.
Intervention type
Behavioural
Primary outcome measure
Weight (kg) is measured using the SECA 704 at 0, 6, 12 and 18 months
Secondary outcome measures
Secondary outcome measures will be collected at 0, 6, 12 and 18 months:
1. Proportion of subjects maintaining >0, 5 and 10% weight loss, and drop-out rate
2. Body composition (e.g. fat free mass and fat mass) is measured using the Impedimed SFB7
3. Health biomarkers, including blood pressure and resting heart rate (Using the OMRON M10). Full lipid profile and HbA1c by finger prick method (using the Alere Afinion Analyser) and hair cortisol to measure stress according to a protocol outlines by Van Uum et al. (2008). Please note that the blood and hair samples will only be collected at 0 and 12 months.
4. Intervention impact on physical activity and sleep quantity and quality (e.g. daily minutes of light moderate and vigorous activity, number of steps and distance walked, heart rate throughout the day)]. Objective physical activity and sleep patterns will be analysed using the Fitbit Charge HR 2 throughout the 18 month trial. Self-reported physical activity will also be collected by the IPAQ and Activity Choice Index.
5. Dietary intake at 0, 6, 12 and 18 months through 24 hour recalls on four consecutive days within 7-days of each time point using INTAKE24.
6. Eating Behaviour (Three factor eating inventory, Controllability and automaticity of eating behaviour, Eating in the absence of hunger scale, Intuitive eating scale).
7. Impact of the interventions on well-being and quality of life (Warwick and Edinburgh Wellbeing Scale, EQ5D)
8. Moderators and mediators of behaviour change, including:
8.1. Self-regulation and motivation (Action planning and coping scales, Basic Psychological Needs and Frustration Scale, Goal content maintenance for weight loss maintenance, BREQ-3, Regulation of eating behaviour scale, Self-efficacy for exercise and easting scales)
8.2. Emotion regulation (including weight focused self-criticism scale, weight focused external shame scale, Body image acceptance and action questionnaire, Engaged living scale, Five dimensions of mindfulness, Difficulties in emotion regulation scale, Mindful attention awareness scale)
8.3. Stress Management (Perceived stress scale and depression, Anxiety and stress scale)
9. Process evaluation to investigate and feedback recruitment/reach to maximise recruitment effectiveness, reasons for engagement, continuation and drop out (through questionnaires), user experience and acceptability of the intervention arms (convenience, ease of use, outcomes for themselves and wider social networks) and unintended consequences. Questionnaires will be distributed to all participants at 0, 1, 3, 6, 12 and 18 months. Focus groups will be conducted after 6 months toolkit usage.
Overall study start date
01/03/2015
Overall study end date
28/02/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Providing written informed consent for study participation prior to any study specific procedures
2. Aged 18 years or older (no upper limit)
3. Initial Body Mass Index (prior to weight loss) of ≥25 kg/m2
4. Written verification of at least 5% of weight loss in the last 12 months by either a physician, health professional, weight loss counsellor or friend
5. Access to a smartphone, tablet or computer with Internet access and WiFi at home to receive reminder messages regarding weight recordings, mobile health intervention modules and intervention assessments
5. Ability to use a standing scale for weight measurements
Participant type(s)
All
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
1600
Participant exclusion criteria
1. Inability to give informed consent
2. Individuals who have lost weight due to illness or surgical procedures, including bariatric procedures
3. Pregnant or planning to become pregnant in the next 18 months
4. Mothers who are breastfeeding
5. Current involvement in other research intervention studies or randomised controlled trials (excluding local health interventions and weight management services)
6. Inability to follow written material or telephone conversations in the English, Danish or Portuguese language (depending on the centre) that would preclude completion of study questionnaires and use the NoHoW TK
7. Diagnosis of anorexia nervosa, bulimia nervosa, purging disorder, or screen positive for symptoms of any of these disorders of eating at baseline
Recruitment start date
20/03/2017
Recruitment end date
31/03/2018
Locations
Countries of recruitment
Denmark, England, Portugal, United Kingdom
Study participating centre
University of Leeds
School of Psychology
Faculty of Medicine and Health
Leeds
LS2 9JZ
United Kingdom
Study participating centre
The Parker Institute
Copenhagen University Hospitals
Bispebjerg and Frederiksberg
Nordre Fasanvej 57
Road 8, Entrance 19
Frederiksberg
Copenhagen
DK-2000
Denmark
Study participating centre
University of Lisbon
Alameda Da Universidade
Lisbon
1600 214
Portugal
Sponsor information
Organisation
The University of Leeds
Sponsor details
School of Psychology
Faculty of Medicine and Health
University of Leeds
Leeds
LS2 9JT
England
United Kingdom
+44 (0)113 3435724
psyc-enquiries@leeds.ac.uk
Sponsor type
University/education
Website
ROR
Funders
Funder type
Other
Funder name
Horizon 2020
Alternative name(s)
EU Framework Programme for Research and Innovation, Horizon 2020 - Research and Innovation Framework Programme, European Union Framework Programme for Research and Innovation
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Results and Publications
Publication and dissemination plan
Planned publications in high-impact peer reviewed journals to be published from 2017 and after the trial end date (2020).
Intention to publish date
31/12/2020
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study will be stored in a publically available repository - The Danish Data archives (DDA, Dansk Data Arkiv), available via https://www.sa.dk/en/services/danish-data-archive.
The process is between the application and the project’s steering committee. To apply for permission to use the data, search for the project via http://dda.dk/simple-search
Following the project (and having achieved intellectual property and publication goals), this data will be made available in DDI (data documentation initiative) formats (as applicable) on the Danish Data archives (DDA, Dansk Data Arkiv), where it can be accessed by bona-fide researchers in the future. Consent was obtained for anonymised participant data to be disseminated and stored for 20 years.
IPD sharing plan summary
Stored in repository
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | sleep study results | 16/07/2020 | 17/07/2020 | Yes | No |
| Protocol article | protocol | 30/09/2019 | 15/01/2021 | Yes | No |
| Other publications | secondary analysis on association between weight variability and cardiometabolic health markers | 02/08/2020 | 18/01/2021 | Yes | No |
| Other publications | Usage and effects of web intervention modules | 14/04/2022 | 19/04/2022 | Yes | No |
| Other publications | User experience of NoHow Toolkit | 10/01/2022 | 19/04/2022 | Yes | No |
| Other publications | Testing motivational and self-regulatory mechanisms of action on device-measured physical activity in the context of a weight loss maintenance digital intervention: A secondary analysis of the NoHoW trial | 01/01/2023 | 05/09/2023 | Yes | No |
| Results article | Primary and secondary analysis | 27/10/2023 | 30/10/2023 | Yes | No |