Neurocognitive Benefits of a Weight Management Program

A Randomized Controlled Trial Examining the Neurocognitive Benefits of a Nationally Available Weight Management Program

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04202133

Enrollment

Registered

2019-12-17

Start date

2019-11-20

Completion date

2021-07-20

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

obesity, weight loss, neuroimaging, fMRI, behavioral obesity treatment

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.

Interventions

BEHAVIORALWW (formerly Weight Watchers)

The WW intervention will consist of weekly group workshops for 16 weeks with WW Coaches and Guides.

BEHAVIORALWaitlist

The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered the WW intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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
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
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

Secondary

Measure	Time frame	Description
Percent Weight	Change from baseline to 16 weeks	Percent weight change
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.
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
N-back Behavioral Performance	Change from baseline to 16 weeks	Change in reaction time (seconds) on the N-back task

Countries

United States

Participant flow

Participants by arm

Arm	Count
WW (Formerly Weight Watchers) 16-weeks of the group-based WW program WW (formerly Weight Watchers): The WW intervention will consist of weekly group workshops for 16 weeks with WW Coaches and Guides.	31
Waitlist Control 16-weeks on waitlist then participants will be provided with 16-weeks of the group-based WW program Waitlist: The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered the WW intervention	30
Total	61

Baseline characteristics

Characteristic	Waitlist Control	Total	WW (Formerly Weight Watchers)
Age, Continuous	40.1 years STANDARD_DEVIATION 11.1	41.1 years STANDARD_DEVIATION 9.9	42 years STANDARD_DEVIATION 8.7
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants	6 Participants	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants	55 Participants	28 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	2 Participants	2 Participants	0 Participants
Race (NIH/OMB) Black or African American	15 Participants	31 Participants	16 Participants
Race (NIH/OMB) More than one race	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	13 Participants	26 Participants	13 Participants
Sex: Female, Male Female	30 Participants	61 Participants	31 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 31	0 / 30
other Total, other adverse events	0 / 31	0 / 30
serious Total, serious adverse events	0 / 31	0 / 30