Engaging Men in Weight Loss With a Game-based mHealth and Neurotraining Program: A 2 x 2 Randomized Design
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Baseline Weight
研究概览
简要总结
Men in the United States have an exceptionally high prevalence of overweight and obesity, i.e., 71.3%, and 42% of men are currently attempting weight loss. However, men are dramatically underrepresented in weight loss programs. Attempts to modestly adapt standard weight loss programs have seen only minimal success. Mobile applications (mHealth apps) have attractive features, but have low male enrollment and poor efficacy as conventionally delivered. A gamified mHealth program offers the possibility of engaging men and enhancing efficacy given that (1) video gaming is highly appealing to men; (2) gamification features (e.g., digital rewards for attaining "streaks" and milestones, competition) are known enhance enjoyment and motivation and facilitate desired behaviors; and (3) "neurotraining" video games featuring repetitive action mechanics, adaptive difficulty, and feedback can train inhibitory control, a basic brain capacity to inhibit intrinsically-generated approach responses that is strongly linked to body mass and the consumption of high-calorie foods. This project evaluates long-term engagement and outcomes of a professionally-designed, game-based weight loss program. As such, 228 overweight men will be randomized to: (1) a 12-month mHealth weight loss program that includes digital self-monitoring, simplified and self-selected dietary targets, physical activity and a control (sham) non-game neurotraining, or (2) a fully-gamified version of this same program, comprised of a behavior change program featuring team-based competition, digital reinforcers for attainment of streaks and milestones, and an integrated neurotraining video game. Aims include evaluating the efficacy of the gamified program in terms of weight loss, diet and physical activity at 12 months, as well as evaluating hypothesized mediators (inhibitory control and engagement), (enjoyment and compliance) and moderators (baseline frequency of video game play and implicit preferences for Inhibitory Control Training-targeted foods).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessors will be blind to condition.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals must be of overweight or obese BMI (25-50 kg/m)
- •Individuals must be adults (aged 18-65)
- •Able to engage in physical activity (defined as walking two city blocks without stopping)
- •Individuals must also provide consent for the research team to contact their personal physician, if necessary, to provide clearance for the prescribed level of physical activity (i.e., walking) or to consult about rapid weight loss
- •Have moderate-to-high implicit preference for high-calorie foods
- •Satisfactory completion of all enrollment procedures]
排除标准
- •Medical condition (e.g., cancer, type I diabetes, renal failure), heavy alcohol use, or psychiatric condition (e.g., active substance abuse, eating disorder) that may pose a risk to the participant during intervention or cause a change in weight
- •Recently began or changed the dosage of medication that can cause significant change in weight
- •History of bariatric surgery
- •Weight loss of ≥ 5% in the previous 3 months
研究组 & 干预措施
Non-gamified program with sham ICT
One group will be assigned to a 12-month mobile weight loss program that includes digital self-monitoring, simplified and self-selected dietary targets (to align with neurotraining and promote autonomy , and behavioral strategies with sham.
干预措施: mHealth behavioral weight loss treatment (Behavioral)
Non-gamified program with Active ICT
One group will be assigned to a 12-month mobile weight loss program that includes digital self-monitoring, simplified and self-selected dietary targets (to align with neurotraining and promote autonomy , and behavioral strategies with active neurotraining.
干预措施: mHealth behavioral weight loss treatment (Behavioral)
Gamified program with sham ICT
One group will receive fully-gamified version of the program with a sham.
干预措施: Gamified behavioral weight loss treatment (Behavioral)
Gamified program with Active ICT
One group will receive fully-gamified version of the program with active neurotraining.
干预措施: Gamified behavioral weight loss treatment (Behavioral)
结局指标
主要结局
Baseline Weight
时间窗: Assessments will be administered at month zero.
Weight will be measured using the Fitibit Aria wireless scale, accurate to 0.2 kg. We will instruct participants to place the scale on a flat, hard surface; weigh upon waking, without clothes, after using the bathroom, require participants to confirm monthly that they are following instructions, require participants to weigh daily, remove incorrect weights, and use the average of 5 daily weights for each timepoint.
Change from Baseline Weight at 6 months
时间窗: Assessment will be administered at month sixth.
Weight will be measured using the Fitibit Aria wireless scale, accurate to 0.2 kg. We will instruct participants to place the scale on a flat, hard surface; weigh upon waking, without clothes, after using the bathroom, require participants to confirm monthly that they are following instructions, require participants to weigh daily, remove incorrect weights, and use the average of 5 daily weights for each timepoint.
Change from Baseline Weight at 12 months
时间窗: Assessment will be administered at month twelve.
Weight will be measured using the Fitibit Aria wireless scale, accurate to 0.2 kg. We will instruct participants to place the scale on a flat, hard surface; weigh upon waking, without clothes, after using the bathroom, require participants to confirm monthly that they are following instructions, require participants to weigh daily, remove incorrect weights, and use the average of 5 daily weights for each timepoint.
Change from Baseline Weight at 1 month
时间窗: Assessment will be administered at month one.
Weight will be measured using the Fitibit Aria wireless scale, accurate to 0.2 kg. We will instruct participants to place the scale on a flat, hard surface; weigh upon waking, without clothes, after using the bathroom, require participants to confirm monthly that they are following instructions, require participants to weigh daily, remove incorrect weights, and use the average of 5 daily weights for each timepoint.
次要结局
- Caloric intake measured using the Fitbit app's built-in dietary tracking system(Assessments will be administered at months 0, 1, 6 and 12.)
- Physical activity measured in minutes of moderate to vigorous physical activity using wrist-worn activity tracker.(Assessments will be administered at months 0, 1, 6 and 12.)
研究者
Evan Forman PhD
Professor of Psychological and Brain Sciences
Drexel University