NCT04202133

Neurocognitive Benefits of a Weight Management Program

Completed Phase 4 Results posted Last updated 10 February 2025

What this trial tests

Phase 4 trial testing WW (formerly Weight Watchers) in Overweight and Obesity in 61 participants. Completed in 20 July 2021.

Timeline

20 November 2019

Primary endpoint
2 April 2021

20 July 2021

Quick facts

Lead sponsor	University of Pennsylvania
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	61
Start date	20 November 2019
Primary completion	2 April 2021
Estimated completion	20 July 2021
Sites	1 location across United States

Drugs / interventions tested

• WW (formerly Weight Watchers)
• Waitlist

Conditions studied

• Overweight and Obesity — all drugs for Overweight and Obesity →

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 60, female only, with Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Blood Oxygen Level-dependent (BOLD) Response to High-calorie Foods Cues Minus Neutral Objects in Left Anterior Cingulate Cortex Primary · Change from baseline to 16 weeks

Changes in BOLD fMRI response to high-calorie food images

Group	Value	95% CI
WW (Formerly Weight Watchers)	-0.05	± 0.05
Waitlist Control	-0.16	± 0.06

Reward-based Eating Primary · 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

Group	Value	95% CI
WW (Formerly Weight Watchers)	-3.9	± 1.4
Waitlist Control	-0.7	± 1.5

Food Cravings- Trait (Lack of Control Over Eating) Primary · 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

Group	Value	95% CI
WW (Formerly Weight Watchers)	-2.7	± 0.8
Waitlist Control	-0.1	± 0.9

Eating Behaviors Primary · 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

Group	Value	95% CI
WW (Formerly Weight Watchers)	-3.2	± 2.1
Waitlist Control	1.0	± 2.3

Hippocampal Volume Primary · Change from baseline to 16 weeks

Change in hippocampal volume

Group	Value	95% CI
WW (Formerly Weight Watchers)	-84.9	± 154.8
Waitlist Control	42.8	± 172.9

Eating Behaviors (Low-calorie Foods) Primary · 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

Group	Value	95% CI
WW (Formerly Weight Watchers)	0.7	± 2.3
Waitlist Control	-0.8	± 2.3

Percent Weight Secondary · Change from baseline to 16 weeks

Percent weight change

Group	Value	95% CI
WW (Formerly Weight Watchers)	-4.7	± 4.9
Waitlist Control	0.2	± 3.5

Eating Behavior Secondary · 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). Subscal

Cognitive restraint

Group	Value	95% CI
WW (Formerly Weight Watchers)	3.5	± 0.6
Waitlist Control	0.3	± 0.7

Hunger

Group	Value	95% CI
WW (Formerly Weight Watchers)	-0.9	± 0.4
Waitlist Control	-0.7	± 0.5

Disinhibition

Group	Value	95% CI
WW (Formerly Weight Watchers)	-1.5	± 0.4
Waitlist Control	-0.4	± 0.5

Power of Food Secondary · 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

Group	Value	95% CI
WW (Formerly Weight Watchers)	-0.4	± 0.6
Waitlist Control	-0.1	± 0.7

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Randomized Controlled Trial of Effects of Behavioral Weight Loss Treatment on Food Cue Reactivity.
   Chao AM, Wadden TA, Cao W, Zhou Y, et al · · 2024 · cited 3× · PMID 37916843 · DOI 10.1097/nnr.0000000000000702
2. A randomized controlled trial examining the effects of behavioral weight loss treatment on hippocampal volume and neurocognition.
   Chao AM, Zhou Y, Erus G, Davatzikos C, et al · · 2023 · cited 2× · PMID 37156318 · DOI 10.1016/j.physbeh.2023.114228