A Randomized Controlled Trial Examining the Neurocognitive Benefits of a Nationally Available Weight Management Program
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Blood Oxygen Level-dependent (BOLD) Response to High-calorie Foods Cues Minus Neutral Objects in Left Anterior Cingulate Cortex
研究概览
简要总结
This study will assess whether weight loss induced through diet and physical activity can change neural responses to high- and low-calorie food images. In addition, it will evaluate whether weight loss can improve neural function when performing the N-back task, a measure of working memory. Findings will address notable gaps in the literature by testing whether a scalable weight loss intervention can help protect and improve neurocognitive functioning and brain health in individuals with obesity. This study will also provide important information about the effects of weight loss on neuroplasticity in brain regions crucial for memory and cognitive functioning, which will help to inform future interventions aimed at promoting brain health.
详细描述
The purpose of the present study is to conduct a randomized controlled trial (RCT) to assess the effects of a commercially available weight loss program (WW; formerly Weight Watchers) on neural response to food cues and memory tasks, as well as on structural brain morphology. Participants with obesity will be randomized to either 16 weeks of an in-person, group-based WW program (n=30) or a wait-list control (WLC; n=30). Both groups will have structural and blood oxygen level-dependent (BOLD) functional magnetic resonance imaging (fMRI) scans at baseline and after the 16-week intervention. Participants will complete the following fMRI tasks: 1) structural scan; 2) food cue task to measure reactivity to high and low-calorie food images and 3) N-back task to measure working memory (i.e., the ability to temporarily hold information available for processing). In addition, participants will complete self-report and behavioral measures of eating behaviors, appetite, physical activity, mood, quality of life, attention and memory at baseline, and weeks 8 and 16.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ages 18-60 years
- •BMI>30 kg/m2
- •Eligible female patients will be:
- •Non-pregnant
- •Non-lactating
- •Surgically sterile or postmenopausal, or they will agree to continue to use an accepted method of birth control during the study. Acceptable methods of birth control are: hormonal contraceptives; double barrier method (condom with spermicide or diaphragm with spermicide); intrauterine device; surgical sterility; abstinence; and/or postmenopausal status (defined as at least 2 years without menses).
- •Participants must:
- •Understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent
排除标准
- •Weight>158.8 kg (350 lbs, due to scanner weight restrictions)
- •Serious medical risk such as type 1 or 2 diabetes, cancer, or recent cardiac event (e.g., heart attack, angioplasty)
- •Untreated thyroid disease or any changes (type or dose) in thyroid medication in the last 6 months
- •Current psychiatric disorder that significantly interferes with daily living
- •Active suicidal ideation
- •Current substance use disorder (current or in remission < 1 year)
- •Presence or history of orthopedic circumstances, metallic inserts, pacemaker, claustrophobia, or other conditions that may interfere with magnetic resonance imaging
- •Participation in a structured weight loss program in the prior 6 months
- •WW member within the past 12 months
- •Use of medications known to induce significant weight loss/gain, including chronic use of oral steroids in the past 3 months
- •Psychiatric hospitalization within the past 6 months
- •Loss of >10 lbs of body weight within the past 3 months
- •History or plans for bariatric surgery
- •Visual, auditory, or other impairment affecting task performance
- •Neurological trauma (e.g., concussion)
- •Inability to attend treatment and/or assessment visits
- •Participant from same household
- •Adherence to specialized diet regimes, such as vegetarian, macrobiotic
- •Lack of capacity to provide informed consent
- •Inability to walk 5 blocks comfortably or engage in some other form of aerobic activity (e.g., swimming)
- •Any serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the study
结局指标
主要结局
Blood Oxygen Level-dependent (BOLD) Response to High-calorie Foods Cues Minus Neutral Objects in Left Anterior Cingulate Cortex
时间窗: Change from baseline to 16 weeks
Changes in BOLD fMRI response to high-calorie food images
Reward-based Eating
时间窗: Change from baseline to 16 weeks
Changes in scores on the Reward-Based Eating Drive Scale; range of 0-52; higher scores indicate higher reward-related eating
Food Cravings- Trait (Lack of Control Over Eating)
时间窗: Change from baseline to 16 weeks
Changes in scores on the Food Cravings Questionnaire- Trait (lack of control over eating), range=6-36, higher scores indicate greater cravings
Food Preference
时间窗: Change from baseline to 16 weeks
Changes in scores on the Leeds Food Preference Questionnaire
Eating Behaviors
时间窗: Change from baseline to 16 weeks
Changes in scores on the Eating Behaviors Questionnaire (liking for high-calorie foods); visual analog scores ranging from 0-100 with higher scores indicating a worse outcome
Hippocampal Volume
时间窗: Change from baseline to 16 weeks
Change in hippocampal volume
BOLD fMRI Response to the N-back Task
时间窗: Change from baseline to 16 weeks
Changes in BOLD fMRI response to the N-back task
Eating Behaviors (Low-calorie Foods)
时间窗: Change from baseline to 16 weeks
Changes in scores on the Eating Behaviors Questionnaire (liking for low-calorie foods); visual analog scores ranging from 0-100 with higher scores indicating a better outcome
次要结局
- Eating Behavior(Change from baseline to 16 weeks)
- N-back Behavioral Performance(Change from baseline to 16 weeks)
- Percent Weight(Change from baseline to 16 weeks)
- Power of Food(Change from baseline to 16 weeks)