Overweight and obese adults who have achieved clinically significant weight loss (5%) Other Obesity
Conditions
Interventions
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-m
Sponsors
The University of Leeds
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight (kg) is measured using the SECA 704 at 0, 6, 12 and 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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, Dif | — |
Countries
Denmark, England, Portugal, United Kingdom
Contacts
Public ContactSarah Scott
Outcome results
None listed