University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT04202133
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.
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Notify Me18 year–60 year
Female
Interventional
Phase 4
Philadelphia, Pennsylvania, 19104, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The WW intervention will consist of weekly group workshops for 16 weeks with WW Coaches and Guides.
The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered the WW intervention
Time frame: Change from baseline to 16 weeks
Changes in BOLD fMRI response to high-calorie food images
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
Time frame: 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
Time frame: Change from baseline to 16 weeks
Changes in scores on the Leeds Food Preference Questionnaire
Time frame: 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
Time frame: Change from baseline to 16 weeks
Change in hippocampal volume
Time frame: Change from baseline to 16 weeks
Changes in BOLD fMRI response to the N-back task
Time frame: 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
Time frame: Change from baseline to 16 weeks
Change in reaction time (seconds) on the N-back task
Time frame: Change from baseline to 16 weeks
Percent weight change
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). 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.
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. Range of scores is 1-5
University of Pennsylvania
Other
A Randomized Controlled Trial Examining the Neurocognitive Benefits of a Nationally Available Weight Management Program
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