Evidence-based information and communications technology tools for weight loss maintenance

• Register: ISRCTN
• Last refreshed on: 13 November 2023
• Main ID: ISRCTN88405328
• Date of registration: 22/12/2016
• Prospective Registration: Yes
• Primary sponsor: The University of Leeds
• Public title: Evidence-based information and communications technology tools for weight loss maintenance
• 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
• Date of first enrolment: 20/03/2017
• Target sample size: 1600
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN88405328
• Study type: Interventional
• Study design: International multi-centre 2 x 2 four-arm randomised controlled trial with adaptive stratified sampling using minimisation (Prevention)
• Phase: Not Applicable

Countries of recruitment

Denmark, England, Portugal, United Kingdom

Contacts

• Name: Sarah Scott

• Name: James Stubbs

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Overweight and obese adults who have achieved clinically significant weight loss (5%)
Not Applicable
Obesity

Intervention(s)

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-man

Primary Outcome(s)

Weight (kg) is measured using the SECA 704 at 0, 6, 12 and 18 months

Secondary Outcome(s)

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.

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Horizon 2020

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; The University of Leeds, School of Psychology Research Ethics Committee, 27/10/2016, ref: 16-0275

Results

• Results available: Yes
• Date Completed: 28/02/2020