Neurocognitive Benefits of a Weight Management Program

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT04202133

Collaborator

Weight Watchers International (Industry)

Enrollment

Location

Arms

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Behavioral: WW (formerly Weight Watchers) Behavioral: Waitlist	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 20, 2019

Actual Primary Completion Date :

Apr 2, 2021

Actual Study Completion Date :

Jul 20, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: WW (formerly Weight Watchers)

16-weeks of the group-based WW program

Behavioral: WW (formerly Weight Watchers)

The WW intervention will consist of weekly group workshops for 16 weeks with WW Coaches and Guides.

Other: Waitlist Control

16-weeks on waitlist then participants will be provided with 16-weeks of the group-based WW program

Behavioral: Waitlist

The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered the WW intervention

Outcome Measures

Primary Outcome Measures

Blood oxygen level-dependent (BOLD) response to food cues [Change from baseline to 16 weeks]
Changes in BOLD fMRI response to high- and low-calorie food images
Reward-based eating [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 [Change from baseline to 16 weeks]
Changes in scores on the Food Cravings Questionnaire; summed scores for subscales; higher scores indicate greater cravings
Food preference [Change from baseline to 16 weeks]
Changes in scores on the Leeds Food Preference Questionnaire
Eating behaviors [Change from baseline to 16 weeks]
Changes in scores on the Eating Behaviors Questionnaire; visual analog scores
Hippocampal volume [Change from baseline to 16 weeks]
Change in hippocampal volume
BOLD fMRI response to the N-back task [Change from baseline to 16 weeks]
Changes in BOLD fMRI response to the N-back task

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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