A Theory-based Digital Intervention to Promote Weight Loss and Weight Loss Maintenance (Choosing Health): A Randomised Controlled Trial With Within Person Assessment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 285
- 试验地点
- 2
- 主要终点
- Weight
研究概览
简要总结
Obesity can severely reduce quality and longevity of life and there is an urgent need to help people lose weight and maintain weight loss long term. Digital behaviour change interventions targeting diet and physical activity have the potential for public health gain; however, these interventions are often not adequately tailored to the participants. The aim of this study is to develop and test a digital intervention to help people make sustainable changes to diet and physical activity, and consequently their weight. This study is a hybrid trial that will evaluate the effectiveness, cost-effectiveness and implementation of the Choosing Health program among overweight/obese adults.
This study is a two-group randomised controlled trial (RCT) with within person assessment. Participants (N=285) will be randomly assigned to either the Choosing Health digital intervention or a control group. For intervention participants, Ecological Momentary Assessment (EMA) will be used to identify behavioural determinants for each individual in order to tailor evidence-based behaviour change techniques and intervention content. Control group will receive non-tailored factual weight loss advice. Primary outcome is mean difference in weight loss between groups at 6 months, in kilograms. Key outcomes will be measured at baseline, 3-, 6- and 12 months. Data will be analysed using multilevel modelling and time series analysis.
This is the first weight loss intervention applying individualised digital tailoring based on continuous assessment of individual's psychological determinants of behaviour measured over time. The Choosing Health will offer insight into factors associated with success in making sustained changes to weight, and secondary outcomes, such as diet and physical activity.
详细描述
Behavioural science offers theory-driven and evidence-based behaviour change techniques that can support people in losing weight and maintaining it long term. These techniques have not yet been assessed in within-person studies that not only examine aggregated between-group effects (e.g., intervention versus control comparisons) but also determine personal trajectories of weight loss and maintenance and tailor accordingly to the strongest predictors of outcomes. The aim of the proposed study is to develop and test a digital intervention that uses Ecological Momentary Assessment (EMA) and tailors the evidence-based behaviour change techniques that are based on theory to the strongest predictors of outcomes (based on EMA responses collected over time).
This study will determine the effectiveness and cost-effectiveness of the proposed intervention through the Randomised Controlled Trial (EMA tailored intervention versus control), with within person component embedded in the trial. Study hypothesis is that participants in the EMA tailored intervention group will lose significantly more weight than participants in the control group from baseline to 6 months (post program comparison - primary outcome) and at 12 months (maintenance effects assessment - secondary outcome).
This is a two-group intervention trial adopting a randomised controlled design. It is a hybrid trial assessing intervention effectiveness, cost-effectiveness and implementation. This study has within person component embedded in the design and intervention group will answer EMA questions during the initial 3 months of the study and will receive tailored intervention at month 3 combined with additional EMA. There are two phases of the 6-month intervention (I) observational EMA phase and (II) active intervention phase.
The proposed intervention is delivered online through emails and text messages and based on the EMA responses in phase I, it is tailored in phase II. The intervention will have a non-automatic component, meaning trained facilitators will answer participants' queries and provide additional resources if and when needed to improve the engagement with the intervention. The study meets CONSORT criteria for RCTs and study ethical approval was obtained from SWPS University of Social Sciences and Humanities, Wroclaw, Poland (approval number 03/P/12/2019).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigator and Outcomes Assessor will be blinded to participants study arm allocation. It is impossible to blind study participants and intervention providers, it is behavioural trial.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults with overweight and obesity (18+);
- •Individuals with a BMI 25 and higher at the baseline assessment.
排除标准
- •Individuals who self-report a physical condition or impairment preventing them from being physically active or losing excess body weight;
- •Individuals who have had a bariatric surgery or are planning to have one within the next 12 months;
- •Individuals who are currently participating in another weight loss program (e.g., regular meetings with personal trainer);
- •Individuals who report any contradictions to exercise as indicated by the PAR-Q or pregnant women who consulted their doctor to obtain approval to take part in the study and did not get the approval;
- •Individuals who do not have a mobile phone with access to the internet;
- •Individuals who are currently participating in another weight loss program (e.g., regular meetings with personal trainer);
- •Pregnant women;
- •Individuals who are planning to move outside of the study region and are not willing to travel for study measurement sessions;
- •Individuals who are on medication that causes weight gain;
- •Individuals with a pacemaker (the scale used in the study is not appropriate for use in these individuals).
结局指标
主要结局
Weight
时间窗: Change from baseline to 6 months
Mean difference in weight loss between groups at 6 months, in kilograms
次要结局
- Self-reported measures of goal conflict(baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3))
- Height(baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3))
- Number of adverse effects(Through study completion, an average of 1 year)
- Weight(baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3))
- Diet(baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3))
- Physical activity (self-reported) and sitting time(baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3))
- Body fat %(baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3))
- Self-reported measures of motivation(baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3))
- Self-reported measures of self-efficacy(baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3))
- Self-reported measures of attitudes(baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3))
- Self-reported measures of action planning(baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3))
- Self-reported measures of coping planning(baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3))
- Systolic and diastolic blood pressure(baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3))
- Alcohol(baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3))
- Health related quality of life(baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3))
- BMI(baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3))
- Sleep duration and quality(baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3))
- Self-reported measures of intentions(baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3))
- Self-reported measures of goal facilitation(baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3))
- Self-reported measures of habit strength for physical activity(baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3))
- Self-reported measures of habit strength for healthy eating(baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3))