Neurocognitive Benefits of a Weight Management Program

Phase 4

Completed

Conditions: Overweight and Obesity

Interventions: Behavioral: Waitlist
Behavioral: WW (formerly Weight Watchers)

Registration Number: NCT04202133

Lead Sponsor: University of Pennsylvania

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 61

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Waitlist Control	Waitlist	16-weeks on waitlist then participants will be provided with 16-weeks of the group-based WW program
WW (formerly Weight Watchers)	WW (formerly Weight Watchers)	16-weeks of the group-based WW program

Primary Outcome Measures

Name	Time	Method
Blood Oxygen Level-dependent (BOLD) Response to High-calorie Foods Cues Minus Neutral Objects in Left Anterior Cingulate Cortex	Change from baseline to 16 weeks	Changes in BOLD fMRI response to high-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- Trait (Lack of Control Over Eating)	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	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 (liking for high-calorie foods); visual analog scores ranging from 0-100 with higher scores indicating a worse outcome
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
Eating Behaviors (Low-calorie Foods)	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

Secondary Outcome Measures

Name	Time	Method
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). The cognitive restraint scale includes 21 items (range 0-21). Higher scores demonstrate more awareness of one's eating and success in restricting dietary intake for weight control. The disinhibited eating scale includes 16 items (range 0-16). Higher scores signify more overeating tendencies. The hunger scale has 14 items and higher scores indicate more perceived hunger (range 0-14). Subscales were analyzed separately.
N-back Behavioral Performance	Change from baseline to 16 weeks	Change in reaction time (seconds) on the N-back task
Percent Weight	Change from baseline to 16 weeks	Percent weight change
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. Range of scores is 1-5