Neurocognitive Benefits of a Weight Management Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial Examining the Neurocognitive Benefits of a Nationally Available Weight Management Program

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: WW (formerly Weight Watchers)
* Behavioral: Waitlist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-60 years Female 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 Exclusion Criteria: 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 Epilepsy 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WW (formerly Weight Watchers)<br>16-weeks of the group-based WW program | Behavioral: WW (formerly Weight Watchers)<br>* The WW intervention will consist of weekly group workshops for 16 weeks with WW Coaches and Guides.<br>|
| Other: Waitlist Control<br>16-weeks on waitlist then participants will be provided with 16-weeks of the group-based WW program | Behavioral: Waitlist<br>* The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered the WW intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood oxygen level-dependent (BOLD) response to food cues | Changes in BOLD fMRI response to high- and low-calorie food images | Change from baseline to 16 weeks | 
| Reward-based eating | Changes in scores on the Reward-Based Eating Drive Scale; range of 0-52; higher scores indicate higher reward-related eating | Change from baseline to 16 weeks | 
| Food cravings | Changes in scores on the Food Cravings Questionnaire; summed scores for subscales; higher scores indicate greater cravings | Change from baseline to 16 weeks | 
| Food preference | Changes in scores on the Leeds Food Preference Questionnaire | Change from baseline to 16 weeks | 
| Eating behaviors | Changes in scores on the Eating Behaviors Questionnaire; visual analog scores | Change from baseline to 16 weeks | 
| Hippocampal volume | Change in hippocampal volume | Change from baseline to 16 weeks | 
| BOLD fMRI response to the N-back task | Changes in BOLD fMRI response to the N-back task | Change from baseline to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| N-back behavioral performance | Change in reaction time (seconds) on the N-back task | Change from baseline to 16 weeks | 
| Accuracy on N-back Task | Accuracy (percent of correct responses) on the N-back task | Change from baseline to 16 weeks | 
| Percent Weight | Percent weight change | Change from baseline to 16 weeks | 
| Blood Pressure | Change in systolic and diastolic blood pressure | Change from baseline to 16 weeks | 
| Waist Circumference | Change in waist circumference | Change from baseline to 16 weeks | 
| Executive Functioning | Changes in executive functioning as measured by the National Institutes of Health Toolbox-Cognitive Function Battery | Change from baseline to 16 weeks | 
| Mood | Changes in mood as measured by the Beck Depression Inventory-II; range 0-63; higher scores indicate greater depressive symptoms | Change from baseline to 16 weeks | 
| Eating Behavior | Changes in eating behavior as measured by the Eating Inventory (Cognitive restraint, disinhibited eating, and hunger subscales, summed scores, higher values indicate greater restraint/disinhibition/hunger) | Change from baseline to 16 weeks | 
| Binge eating and weight control behaviors | Changes in eating behavior as measured by the Questionnaire on Weight and Eating Pattern-5 | Change from baseline to 16 weeks | 
| Power of Food | Changes in eating behavior as measured by the Power of Food Scale; higher scores indicate greater hedonic hunger | Change from baseline to 16 weeks | 
| Palatable Eating Motives | Changes in eating behavior as measured by the Palatable Eating Motives- Revised; total score and subscale scores (coping, reward enhancement, conformity, social motives) with higher scores indicating greater consumption of tasty foods for non-metabolic reasons | Change from baseline to 16 weeks | 
| Portion sizes | Changes in eating behavior as measured by the Modified Eating Patterns Questionnaire; higher scores indicate higher thresholds for perceived portions | Change from baseline to 16 weeks | 
| Disordered Eating Behaviors and Thoughts | Changes in disordered eating behaviors and thoughts as measured by the Eating Disorder Examination Questionnaire (Global score and subscales; range 0-6 with higher scores indicating greater psychopathology; frequency of disordered eating behaviors) | Change from baseline to 16 weeks | 
| Stress | Changes in stress as measured by the Perceived Stress Scale; range of 0-40 with higher scores indicating more stress | Change from baseline to 16 weeks | 
| Perceived Nutrition Environment | Changes in perceived nutrition environment as measured by the Perceived Nutrition Environment | Change from baseline to 16 weeks | 
| Resilience | Changes in resilience as measured by the Brief Resilience Scale; range of 6-30; greater scores indicate more resilience | Change from baseline to 16 weeks | 
| Food Addiction | Changes in food addiction as measured by the Yale Food Addiction Scale 2.0; greater scores indicate greater food addiction symptoms | Change from baseline to 16 weeks | 
| Physical Activity | Changes in physical activity as measured by the Paffenbarger Physical Activity Questionnaire | Change from baseline to 16 weeks | 
| Generic Quality of Life | Changes in generic quality of life as measured by the Short Form-36; total and subscale scores; higher scores indicate better quality of life | Change from baseline to 16 weeks | 
| Weight-related Quality of Life | Changes in weight-related quality of life as measured by Impact of Weight on Quality of Life-Lite; total score and 5 subscales; t-scores ranging from 0 (low) to 100 (better) | Change from baseline to 16 weeks | 
| Self-regulation | Changes in self-regulation as measured by the Index of Self-Regulation; higher scores indicate greater self-regulation | Change from baseline to 16 weeks | 
| Inhibition | Changes in inhibition as measured by the Behavioral Avoidance/Inhibition Scales; drive, fun seeking, reward responsiveness, inhibition; higher scores | Change from baseline to 16 weeks | 
| Adherence | Changes in adherence as measured by the number of sessions attended and the number of self-monitoring records completed | Change from baseline to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, weight loss, neuroimaging, fMRI, behavioral obesity treatment