Neurocognitive Benefits of a Weight Management Program

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: Overweight and Obesity
• Intervention / Treatment: Behavioral: WW (formerly Weight Watchers); Behavioral: Waitlist

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

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Oxygen Level-dependent (BOLD) Response to High-calorie Foods Cues Minus Neutral Objects in Left Anterior Cingulate Cortex	Changes in BOLD fMRI response to high-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- Trait (Lack of Control Over Eating)	Changes in scores on the Food Cravings Questionnaire- Trait (lack of control over eating), range=6-36, 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 (liking for high-calorie foods); visual analog scores ranging from 0-100 with higher scores indicating a worse outcome	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
Eating Behaviors (Low-calorie Foods)	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	Change from baseline to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Weight	Percent weight change	Change from baseline to 16 weeks
N-back Behavioral Performance	Change in reaction time (seconds) on the N-back task	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). 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.	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. Range of scores is 1-5	Change from baseline to 16 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: WW International Inc
• Investigators: Principal Investigator: Ariana M. Chao, PhD, CRNP, University of Pennsylvania

Study record dates

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): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: neuroimaging; obesity; fMRI; weight loss; behavioral obesity treatment
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• 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