- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04202133
Neurocognitive Benefits of a Weight Management Program
July 27, 2021 updated by: University of Pennsylvania
A Randomized Controlled Trial Examining the Neurocognitive Benefits of a Nationally Available Weight Management Program
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
61
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WW (formerly Weight Watchers)
16-weeks of the group-based WW program
|
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
|
The waitlist group will have a 16-week waitlist period.
After the waitlist period, they will be offered the WW intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood oxygen level-dependent (BOLD) response to food cues
Time Frame: Change from baseline to 16 weeks
|
Changes in BOLD fMRI response to high- and low-calorie food images
|
Change from baseline to 16 weeks
|
Reward-based eating
Time Frame: 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
|
Change from baseline to 16 weeks
|
Food cravings
Time Frame: Change from baseline to 16 weeks
|
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
Time Frame: Change from baseline to 16 weeks
|
Changes in scores on the Leeds Food Preference Questionnaire
|
Change from baseline to 16 weeks
|
Eating behaviors
Time Frame: Change from baseline to 16 weeks
|
Changes in scores on the Eating Behaviors Questionnaire; visual analog scores
|
Change from baseline to 16 weeks
|
Hippocampal volume
Time Frame: Change from baseline to 16 weeks
|
Change in hippocampal volume
|
Change from baseline to 16 weeks
|
BOLD fMRI response to the N-back task
Time Frame: Change from baseline to 16 weeks
|
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
Time Frame: Change from baseline to 16 weeks
|
Change in reaction time (seconds) on the N-back task
|
Change from baseline to 16 weeks
|
Accuracy on N-back Task
Time Frame: Change from baseline to 16 weeks
|
Accuracy (percent of correct responses) on the N-back task
|
Change from baseline to 16 weeks
|
Percent Weight
Time Frame: Change from baseline to 16 weeks
|
Percent weight change
|
Change from baseline to 16 weeks
|
Blood Pressure
Time Frame: Change from baseline to 16 weeks
|
Change in systolic and diastolic blood pressure
|
Change from baseline to 16 weeks
|
Waist Circumference
Time Frame: Change from baseline to 16 weeks
|
Change in waist circumference
|
Change from baseline to 16 weeks
|
Executive Functioning
Time Frame: Change from baseline to 16 weeks
|
Changes in executive functioning as measured by the National Institutes of Health Toolbox-Cognitive Function Battery
|
Change from baseline to 16 weeks
|
Mood
Time Frame: 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
|
Change from baseline to 16 weeks
|
Eating Behavior
Time Frame: 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)
|
Change from baseline to 16 weeks
|
Binge eating and weight control behaviors
Time Frame: Change from baseline to 16 weeks
|
Changes in eating behavior as measured by the Questionnaire on Weight and Eating Pattern-5
|
Change from baseline to 16 weeks
|
Power of Food
Time Frame: Change from baseline to 16 weeks
|
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
Time Frame: 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
|
Change from baseline to 16 weeks
|
Portion sizes
Time Frame: 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
|
Change from baseline to 16 weeks
|
Disordered Eating Behaviors and Thoughts
Time Frame: 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)
|
Change from baseline to 16 weeks
|
Stress
Time Frame: 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
|
Change from baseline to 16 weeks
|
Perceived Nutrition Environment
Time Frame: Change from baseline to 16 weeks
|
Changes in perceived nutrition environment as measured by the Perceived Nutrition Environment
|
Change from baseline to 16 weeks
|
Resilience
Time Frame: 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
|
Change from baseline to 16 weeks
|
Food Addiction
Time Frame: 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
|
Change from baseline to 16 weeks
|
Physical Activity
Time Frame: Change from baseline to 16 weeks
|
Changes in physical activity as measured by the Paffenbarger Physical Activity Questionnaire
|
Change from baseline to 16 weeks
|
Generic Quality of Life
Time Frame: 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
|
Change from baseline to 16 weeks
|
Weight-related Quality of Life
Time Frame: 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)
|
Change from baseline to 16 weeks
|
Self-regulation
Time Frame: Change from baseline to 16 weeks
|
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
Time Frame: 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
|
Change from baseline to 16 weeks
|
Adherence
Time Frame: 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
|
Change from baseline to 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ariana M. Chao, PhD, CRNP, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2019
Primary Completion (Actual)
April 2, 2021
Study Completion (Actual)
July 20, 2021
Study Registration Dates
First Submitted
December 3, 2019
First Submitted That Met QC Criteria
December 16, 2019
First Posted (Actual)
December 17, 2019
Study Record Updates
Last Update Posted (Actual)
July 29, 2021
Last Update Submitted That Met QC Criteria
July 27, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 834404
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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