Clinical trial NCT04202133: Neurocognitive Benefits of a Weight Management Program
Official title: A Randomized Controlled Trial Examining the Neurocognitive Benefits of a Nationally Available Weight Management Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overweight and Obesity
Keywords: obesity
weight loss
neuroimaging
fMRI
behavioral obesity treatment
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: WW International Inc
First posted: 2019-12-17
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood Oxygen Level-dependent (BOLD) Response to High-calorie Foods Cues Minus Neutral Objects in Left Anterior Cingulate Cortex
timeFrame: Change from baseline to 16 weeks
measure: Reward-based Eating
timeFrame: Change from baseline to 16 weeks
measure: Food Cravings- Trait (Lack of Control Over Eating)
timeFrame: Change from baseline to 16 weeks
measure: Food Preference
timeFrame: Change from baseline to 16 weeks
measure: Eating Behaviors
timeFrame: Change from baseline to 16 weeks
measure: Hippocampal Volume
timeFrame: Change from baseline to 16 weeks
measure: BOLD fMRI Response to the N-back Task
timeFrame: Change from baseline to 16 weeks
measure: Eating Behaviors (Low-calorie Foods)
timeFrame: Change from baseline to 16 weeks
Secondary outcomes:
measure: N-back Behavioral Performance
timeFrame: Change from baseline to 16 weeks
measure: Percent Weight
timeFrame: Change from baseline to 16 weeks
measure: Eating Behavior
timeFrame: Change from baseline to 16 weeks
measure: Power of Food
timeFrame: Change from baseline to 16 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ariana M. Chao, PhD, CRNP
role: PRINCIPAL_INVESTIGATOR
References: