The NULevel trial of a scalable, technology-assisted weight loss maintenance intervention for obese adults after clinically significant weight loss: Study protocol for a randomised controlled trial
MetadataShow full item record
This open access article is distributed under the Creative Commons license http://creativecommons.org/licenses/by/4.0/
Background: Effective weight loss interventions are widely available but, after weight loss, most individuals regain weight. This article describes the protocol for the NULevel trial evaluating the effectiveness and cost-effectiveness of a systematically developed, inexpensive, scalable, technology-assisted, behavioural intervention for weight loss maintenance (WLM) in obese adults after initial weight loss. Methods/Design: A 12-month single-centre, two-armed parallel group, participant randomised controlled superiority trial is underway, recruiting a total of 288 previously obese adults after weight loss of ≥5 % within the previous 12 months. Participants are randomly assigned to intervention or control arms, with a 1:1 allocation, stratified by sex and percentage of body weight lost (<10 % vs ≥10 %). Change in weight (kg) from baseline to 12 months is the primary outcome. Weight, other anthropometric variables and 7-day physical activity (assessed via accelerometer) measures are taken at 0 and 12 months. Questionnaires at 0, 6 and 12 months assess psychological process variables, health service use and participant costs. Participants in the intervention arm initially attend an individual face-to-face WLM consultation with an intervention facilitator and then use a mobile internet platform to self-monitor and report their diet, daily activity (via pedometer) and weight through daily weighing on wirelessly connected scales.Automated feedback via mobile phone, tailored to participants’ weight regain and goal progress is provided. Participants in the control arm receive quarterly newsletters (via links embedded in text messages) and wirelessly connected scales. Qualitative process evaluation interviews are conducted with a subsample of up to 40 randomly chosen participants. Acceptability and feasibility of procedures, cost-effectiveness, and relationships among socioeconomic variables and WLM will also be assessed. Discussion: It is hypothesised that participants allocated to the intervention arm will show significantly lower levels of weight regain from baseline than those in the control arm. To date, this is the first WLM trial using remote real-time weight monitoring and mobile internet platforms to deliver a flexible, efficient and scalable intervention, tailored to the individual. This trial addresses a key research need and has the potential to make a vital contribution to the evidence base to inform future WLM policy and provision.
Showing items related by title, author, creator and subject.
Living well after breast cancer randomized controlled trial protocol: evaluating a telephone-delivered weight loss intervention versus usual care in women following treatment for breast cancerReeves, M.; Terranova, C.; Erickson, J.; Job, J.; Brookes, D.; McCarthy, N.; Hickman, I.; Lawler, S.; Fjeldsoe, B.; Healy, Genevieve; Winkler, E.; Janda, M.; Veerman, J.; Ware, R.; Prins, J.; Vos, T.; Demark-Wahnefried, W.; Eakin, E. (2016)BACKGROUND: Obesity, physical inactivity and poor diet quality have been associated with increased risk of breast cancer-specific and all-cause mortality as well as treatment-related side-effects in breast cancer survivors. ...
Effectiveness of brief structured interventions on risk factor modification for patients with coronary heart disease: a systematic reviewFernandez, R.; Griffiths, R.; Everett, B.; Davidson, Patricia; Salamonson, Yenna; Andrew, S. (2007)Background: The physical and psychosocial benefits of participation in cardiac rehabilitation following a coronary event have well been established. Despite these benefits there is strong evidence that participation in ...
Living well with diabetes: A randomized controlled trial of a telephone-delivered intervention for maintenance of weight loss, physical activity and glycaemic control in adults with type 2 diabetesEakin, E.; Reeves, M.; Marshall, A.; Dunstan, D.; Graves, N.; Healy, Genevieve; Bleier, J.; Barnett, A.; O'Moore-Sullivan, T.; Russell, A.; Wilkie, K. (2010)Background. By 2025, it is estimated that approximately 1.8 million Australian adults (approximately 8.4% of the adult population) will have diabetes, with the majority having type 2 diabetes. Weight management via improved ...