Phase 4
N=61
Neurocognitive Benefits of a Weight Management Program
Overweight and Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04202133 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Blood Oxygen Level-dependent (BOLD) Response to High-calorie Foods Cues Minus Neutral Objects in Left Anterior Cingulate Cortex — -0.05; -0.16 percent BOLD signal change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- WW (formerly Weight Watchers) (Behavioral); Waitlist (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Pennsylvania
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Oxygen Level-dependent (BOLD) Response to High-calorie Foods Cues Minus Neutral Objects in Left Anterior Cingulate Cortex |
-0.05; -0.16 | — |
| PRIMARY Reward-based Eating |
-3.9; -0.7 | — |
| PRIMARY Food Cravings- Trait (Lack of Control Over Eating) |
-2.7; -0.1 | — |
| PRIMARY Food Preference |
— | — |
| PRIMARY Eating Behaviors |
-3.2; 1.0 | — |
| PRIMARY Hippocampal Volume |
-84.9; 42.8 | — |
| PRIMARY BOLD fMRI Response to the N-back Task |
— | — |
| PRIMARY Eating Behaviors (Low-calorie Foods) |
0.7; -0.8 | — |
| SECONDARY N-back Behavioral Performance |
— | — |
| SECONDARY Percent Weight |
-4.7; 0.2 | — |
| SECONDARY Eating Behavior |
3.5; 0.3; -0.9; -0.7; -1.5; -0.4 | — |
| SECONDARY Power of Food |
-0.4; -0.1 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT04202133). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.