Evaluating Environmental Control (AVOID) and Inhibitory Control (RESIST) Strategies to Improve Weight Management Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 503
- 试验地点
- 1
- 主要终点
- Change in BMI from baseline to 12 months.
研究概览
简要总结
The proposed randomized controlled trial tests two self-regulatory approaches to improve intentional weight loss and diet quality in individuals with overweight or obesity: (1) an environmental control strategy (AVOID) and (2) an impulse control training strategy (RESIST).
详细描述
Evidence-based weight management programs are effective when individuals are able to consistently adhere to recommendations. However, a large proportion of treatment-seeking individuals do not experience clinically significant weight loss. Innovative strategies are needed to optimize behavior change in weight management interventions. The proposed randomized controlled trial tests two self-regulatory approaches to improve intentional weight loss and diet quality in individuals with overweight or obesity: (1) an environmental control strategy (AVOID) and (2) an impulse control training strategy (RESIST). Specifically, 500 women and men (BMI between 25-45 kg/m2) will be recruited from the Cedars-Sinai Medical Center network of hospitals and clinics. All participants will be enrolled in a 12-month weight-management program (WW, formerly Weight Watchers©) focusing on diet, physical activity and mindset skills, and randomized to one of four study arms: (1) WW only, (2) WW + modification of home food environment and online grocery delivery (AVOID), (3) WW + gamified inhibitory control training (RESIST), (4) WW + AVOID + RESIST. Baseline, 6- and 12-month assessments will be completed by experienced, English and Spanish speaking study staff. Aim 1 (Outcomes). (a) Tests how AVOID and RESIST affect weight loss and waist circumference (primary) and diet quality (secondary). H1a: AVOID and/or RESIST (arms 2, 3, 4) will result in greater weight loss at 6-month and 12-month timepoints compared to WW alone. (b) Tests potential ripple effects of AVOID and RESIST on available household members' diet quality (primary) and weight (secondary). H1b: The investigators predict that AVOID (arms 2 and 4) will produce greater dietary changes in household members than WW alone and RESIST (arms 1 and 3). Aim 2 (Mechanisms). Tests the mechanistic pathways of AVOID and RESIST by (a) comparing longitudinal changes in inhibitory control and home food environment across study arms; and (b) whether inhibitory control and the home food environment mediate the relationships between study arms and anthropometric and dietary outcomes. H2: AVOID will produce changes in the home food environment and RESIST will operate on inhibitory control. Aim 3 (Moderators). Examines how (a) individual characteristics (age, sex, ethnicity, socioeconomic status, household composition, physical activity, baseline BMI and executive functioning), and (b) process data (frequency of grocery delivery, dining out and take out, impulse control training and WW app use) moderate the relationship between study arms and anthropometric and dietary outcomes. These considerations are important to help explain heterogeneity in intervention outcomes and to understand who benefits from AVOID and/or RESIST.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(Main participants):
- •Age 18 years or older
- •BMI between 25-45 kg/m2
- •Read, write, and speak English with acceptable visual acuity
- •Has a household member (≥ 14 years) willing to complete three brief assessments over 12 months* *Only applies to individuals who indicate they are cohabitating with at least one eligible household member
- •Inclusion Criteria (Household participants):
- •14-years-old
- •Parent consent for children <18-years-old
- •Willingness to complete assessments / measurements
排除标准
- •(Main participants):
- •Currently enrolled in weight loss interventions or undergoing bariatric surgery
- •Pregnant women
- •Individuals for whom weight loss may be contraindicated (e.g., unstable coronary artery disease, end-stage disease, active cancer treatment, uncontrolled insulin-dependent diabetes, portal hypertension, drug/alcohol abuse)
- •Individuals with severe cognitive delays or visual/hearing impairment
- •Individuals who are unable or unwilling to complete the study assessments / measurements
- •Exclusion Criteria (Household participants):
- •≤ 14-years-old
- •Individuals who are unable or unwilling to complete the study assessments / measurements
研究组 & 干预措施
WW Only
WW is commercially-available weight management program focusing on diet, physical activity and mindset skills.
干预措施: WW (Behavioral)
WW + Home modification and grocery delivery (AVOID)
WW + modification of home food environment + online grocery shopping and delivery
干预措施: Home food environment and grocery delivery (AVOID) (Behavioral)
WW + Home modification and grocery delivery (AVOID)
WW + modification of home food environment + online grocery shopping and delivery
干预措施: WW (Behavioral)
WW + Inhibitory control training (RESIST)
WW + daily gamified inhibitory control training
干预措施: Inhibitory control training (RESIST) (Behavioral)
WW + Inhibitory control training (RESIST)
WW + daily gamified inhibitory control training
干预措施: WW (Behavioral)
WW + Home food modification and grocery delivery (AVOID) + Inhibitory control training (RESIST)
WW + modification of home food environment + online grocery shopping and delivery + daily gamified inhibitory control training
干预措施: Home food environment and grocery delivery (AVOID) (Behavioral)
WW + Home food modification and grocery delivery (AVOID) + Inhibitory control training (RESIST)
WW + modification of home food environment + online grocery shopping and delivery + daily gamified inhibitory control training
干预措施: Inhibitory control training (RESIST) (Behavioral)
WW + Home food modification and grocery delivery (AVOID) + Inhibitory control training (RESIST)
WW + modification of home food environment + online grocery shopping and delivery + daily gamified inhibitory control training
干预措施: WW (Behavioral)
结局指标
主要结局
Change in BMI from baseline to 12 months.
时间窗: Baseline, 6-month, 12-month
BMI will be calculated by aggregating participants' self-reported height in meters and weight in kilograms at baseline, 6- and 12-months.
次要结局
- Diet quality assessed by 24h-dietary recall(Baseline, 6-month, 12-month)
研究者
Sarah Salvy
Professor, Department of Medicine
Cedars-Sinai Medical Center
